Steps Involved in Pharmaceutical Tablet Development
•Als PPTX, PDF herunterladen•
1 gefällt mir•8 views
Pharmaceutical tablet development is a complex process that requires meticulous attention to detail and adherence to strict quality standards. From conceptualization to market release, each step plays a crucial role in ensuring the safety, efficacy, and stability of the final product. In this article, we will delve into the various steps involved in pharmaceutical tablet development, providing a comprehensive overview for both industry professionals and curious minds. https://pharmaceuticalcarrier.com/2024/02/25/steps-involved-in-pharmaceutical-tablet-development/
Melden
Teilen
Melden
Teilen
Empfohlen
Get Your Development Program Started on the Right Foot
You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.
How early is too early charles view 5jun2017
How early is too early for pharmaceutical market insights and product forecasts. A discussion on pipeline product research during early product development
school practice_240130_141325.PDF
Formulation development is the process of combining an active drug with other ingredients to create a stable, bioavailable, and effective final product. It involves pre-formulation studies, design and testing, manufacturing, and stability testing. The goal is to identify the most effective delivery method for the active drug. Key steps include analytical development, particle characterization, dissolution testing, and excipient screening. Drugs then progress through preclinical and clinical research phases to test safety and efficacy before seeking regulatory approval. Post-approval monitoring ensures the drug's safe use. Factors like a drug's properties, intended use, and stability studies guide its formulation.
Need for an Integrated approach to Formulation Research and Knowledge Management
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
lecture 2 slides.pptxlecture 2 slides sdfswssdsdsdsdsdsdsdsd.pptxlecture 2 sl...
jklkd;kvd
;;l;. ;.. ;dl;gldg;gl;[kd[fhjkohg
;lgjkfgjkdlgklfgllfg
ll;l;;;;;f'ffffiiriieeopoeeppe
fefefefefeffef
efefefefcvvxcvxc xcvvsewffsdv dsfwefw f
efwefweflecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxvvvvvvvvvvvvvvvvvvvvvlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptx
@Ndd
Once a new compound is identified, it undergoes a multi-step drug development process before FDA approval. This includes preclinical testing in labs and animals to evaluate safety and efficacy. If results are promising, an IND application is filed for clinical trials involving human subjects in 3 phases to further assess safety, effectiveness, and proper dosing. Upon successful completion of clinical trials, an NDA is filed with comprehensive data for FDA review. If approved, the drug can be marketed and requires ongoing monitoring and reporting to FDA.
Marketing Research ppt
The document discusses the process and methodology of marketing research in the pharmaceutical industry. It describes 8 key steps: 1) defining the problem, 2) setting research objectives, 3) designing the research plan including selecting samples, 4) collecting data through surveys, observation, and experiments, 5) analyzing the collected data, 6) creating a situational model based on the data, 7) evaluating the model, and 8) deciding on an optimal marketing strategy. The goal is to systematically obtain information needed for marketing decisions through objective research in order to launch successful products and maximize competitive advantage.
Final navigating multiple clinical trial requirements for the us
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Empfohlen
Get Your Development Program Started on the Right Foot
You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.
How early is too early charles view 5jun2017
How early is too early for pharmaceutical market insights and product forecasts. A discussion on pipeline product research during early product development
school practice_240130_141325.PDF
Formulation development is the process of combining an active drug with other ingredients to create a stable, bioavailable, and effective final product. It involves pre-formulation studies, design and testing, manufacturing, and stability testing. The goal is to identify the most effective delivery method for the active drug. Key steps include analytical development, particle characterization, dissolution testing, and excipient screening. Drugs then progress through preclinical and clinical research phases to test safety and efficacy before seeking regulatory approval. Post-approval monitoring ensures the drug's safe use. Factors like a drug's properties, intended use, and stability studies guide its formulation.
Need for an Integrated approach to Formulation Research and Knowledge Management
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
lecture 2 slides.pptxlecture 2 slides sdfswssdsdsdsdsdsdsdsd.pptxlecture 2 sl...
jklkd;kvd
;;l;. ;.. ;dl;gldg;gl;[kd[fhjkohg
;lgjkfgjkdlgklfgllfg
ll;l;;;;;f'ffffiiriieeopoeeppe
fefefefefeffef
efefefefcvvxcvxc xcvvsewffsdv dsfwefw f
efwefweflecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxvvvvvvvvvvvvvvvvvvvvvlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptxlecture 2 slides.pptx
@Ndd
Once a new compound is identified, it undergoes a multi-step drug development process before FDA approval. This includes preclinical testing in labs and animals to evaluate safety and efficacy. If results are promising, an IND application is filed for clinical trials involving human subjects in 3 phases to further assess safety, effectiveness, and proper dosing. Upon successful completion of clinical trials, an NDA is filed with comprehensive data for FDA review. If approved, the drug can be marketed and requires ongoing monitoring and reporting to FDA.
Marketing Research ppt
The document discusses the process and methodology of marketing research in the pharmaceutical industry. It describes 8 key steps: 1) defining the problem, 2) setting research objectives, 3) designing the research plan including selecting samples, 4) collecting data through surveys, observation, and experiments, 5) analyzing the collected data, 6) creating a situational model based on the data, 7) evaluating the model, and 8) deciding on an optimal marketing strategy. The goal is to systematically obtain information needed for marketing decisions through objective research in order to launch successful products and maximize competitive advantage.
Final navigating multiple clinical trial requirements for the us
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Software Used In Formulation Design Process (Pharmaceutics).Pdf
This is an Minor project of mine, to explaining the Various software which are generally used in the designing for drug dosage form .
This project gave me more of the knowledge about drug designing.
In which lots of software are considered as Formulation.
Helping for PHARMACEUTICS, PHARMACEUTICAL ANALYSIS student. And some of articles review.
It's data are from standard as well as notebook.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Life Sciences Network marcus evans
Presentation by Andreas Grauer, MD, Executive Medical Director, Global Development Leader, Amgen at the marcus evans Evolution Summit Fall 2015 in Las VegasDrug Discovery Method (Bioinformatics)
The document discusses drug design and the drug development process. It describes the two main types of drug design: ligand-based drug design, which relies on knowledge of molecules that bind to the biological target, and structure-based drug design, which models the 3D structure of a protein target. The drug development process involves six main stages: hit identification, pre-clinical studies, manufacturing, clinical trials, regulatory evaluation, and marketing. Overall, drug discovery and development is a complex, expensive process that can take 15 years from initial screening to FDA approval and market launch.
Lionberger gpha-2015
This document summarizes a presentation given by Dr. Robert Lionberger on the FDA's Office of Generic Drugs' (OGD) regulatory science priorities and accomplishments under the Generic Drug User Fee Amendments of 2012 (GDUFA). It introduces the Office of Research and Standards and discusses their work establishing equivalence standards and evaluating generic drugs, with a focus on five priority areas - post-market evaluation, complex products, locally-acting drugs, therapeutic equivalence standards, and computational tools. Updates on research projects, guidances, and interactions with industry are provided. The goal of the regulatory science program is to facilitate generic drug development and ensure therapeutic equivalence.
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
The document discusses pharmaceutical development and design according to ICH Q8 guidelines. It emphasizes using prior knowledge to establish a quality target product profile that defines the essential characteristics needed for safety, efficacy and intended use. Critical quality attributes are identified through risk assessment and studies that link material attributes to product performance. A control strategy is developed and includes designing a robust formulation and manufacturing process within a defined design space to consistently produce the desired quality product. The process emphasizes continual improvement and management of product knowledge throughout the lifecycle.
FDA applications in a nutshell
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
This presentation discusses integrated strategies for overcoming formulation challenges in drug development. It describes Quotient Sciences' approach of integrating formulation development, clinical testing, and manufacturing to accelerate programs and reduce costs. Examples are provided of enhancing solubility for poorly soluble drugs, developing modified release formulations, selecting formulations for first-in-human studies, and formulating peptides for oral delivery. The benefits of this integrated approach include timelines accelerated by over 12 months, significant cost savings, and a greater likelihood of success.
The Role of RWE in Drug Development_4Jun2015_final
This document discusses how real-world evidence (RWE) can be incorporated earlier and more broadly in the drug development process. It proposes a revised model where RWE is used from early research through commercialization to inform target profiles, messaging on unmet needs, and clinical trial design. Specifically, it suggests using RWE to "stress test" enrollment projections and identify referral sources. The document also advocates for moving beyond observational research to conduct cluster-randomized real-world experiments addressing outcomes important to payers and patients like treatment patterns and costs.
The assessed listed medicines pathway
This document discusses the assessed listed medicines pathway, a new pathway established under recommendations from an Australian medicines review. It provides three options for sponsors to list complementary medicines in Australia, including an option where sponsors can submit evidence of a product's efficacy to the Therapeutic Goods Administration (TGA) for pre-market assessment and be provided an AUSTL(A) number and ability to note the product was independently assessed. Key requirements and features of this pathway include sponsors submitting evidence of a product's intermediate-level indications, quality, safety and efficacy. The TGA will assess the evidence and product label before listing.
Multi criteria value-maximization methods for the prioritization of r&d inves...
This document discusses the need for systematically prioritizing limited resources for R&D investments in global health product development. It notes that certain diseases, products, R&D areas, and actors are in need of prioritization due to scarce funding. A multi-criteria decision analysis tool is proposed to help assess optimal R&D priority setting and investment decisions by considering various stakeholder concerns, objectives, and criteria. The document outlines a project to develop such a tool through establishing conceptual and methodological frameworks, conducting a global survey, and testing the tool at multiple levels of decision making.
4 Dr Jian Wang Health Canada
4 Dr Jian Wang Health CanadaInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Health Canada's Clinical Evaluation Division chief Jian Wang presented on clinical data requirements and key issues for market authorization of biotherapeutics. Wang discussed Health Canada's international collaborations and highlighted regulatory authorities' decision-making based on efficacy and safety. He outlined submission data requirements including quality, non-clinical, clinical, and risk management data. Wang also reviewed key clinical trial design considerations and common efficacy and safety issues with biologics. He emphasized that benefit-risk assessments are context-specific and can lead different regulatory decisions in different jurisdictions based on the same data.Application for New Drug Discovery (NDD) according to USFDA guidelines
The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
How and When to Kill a Program in New Product Planning
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Fundamental of-product-development
This document discusses key aspects of product development for pharmaceutical products. It covers stages of product development including drug discovery, formulation development, process research and development, analytical research, toxicology testing, and clinical trials. It discusses important considerations for product design such as target product profiles, design specifications, commercial factors, technical risks, safety, intellectual property, and environmental impacts. Methods for testing drug-excipient compatibility like DSC, chromatography, and microscopy are also summarized. The importance of pilot plant scale up is discussed to help identify issues prior to full production.
Jennifer maguire and karen bernard
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
IriSys Profile Presentation widescreen V.2.3
IRISYS is a pharmaceutical contract development and manufacturing organization founded in 1996 that offers services from preclinical formulation development through commercial manufacturing. It has extensive experience working with a wide range of clients, including small biotechs and large pharmaceutical companies. IRISYS has state-of-the-art facilities inspected by the FDA and is compliant with cGMP regulations. It has expertise in developing formulations across multiple dosage forms and technologies to meet various drug properties and delivery objectives.
PHARMACEUTICS.pptx
This document provides an introduction to pharmaceutics, which is concerned with the preparation and use of medicinal drugs. It discusses key topics including:
- The sources of drugs, pharmacology analysis, and active ingredients
- The design and manufacture of dosage forms, which combine active ingredients with excipients to facilitate drug delivery
- Quality assurance processes to ensure safe and effective drug production in a consistent manner
- The six main areas of pharmaceutics including physical chemistry principles, biopharmaceutics, dosage form design, manufacturing processes, sterilization, and product testing
- Factors considered in dosage form design like drug properties, administration route requirements, and therapeutic indications
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
The document discusses regulatory requirements for drug approval. It covers the drug development process including non-clinical and clinical development teams. The non-clinical team conducts pre-clinical studies in animals to evaluate efficacy, safety, and viability of manufacturing. Clinical trials have multiple phases to test drugs on humans. A New Drug Application is submitted to regulatory authorities for marketing approval and includes preclinical and clinical data. The drug development process takes 10-12 years and involves interactions between scientific disciplines.
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
Weitere ähnliche Inhalte
Ähnlich wie Steps Involved in Pharmaceutical Tablet Development
Software Used In Formulation Design Process (Pharmaceutics).Pdf
This is an Minor project of mine, to explaining the Various software which are generally used in the designing for drug dosage form .
This project gave me more of the knowledge about drug designing.
In which lots of software are considered as Formulation.
Helping for PHARMACEUTICS, PHARMACEUTICAL ANALYSIS student. And some of articles review.
It's data are from standard as well as notebook.
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. In this presentation, Dr. David Shoemaker, SVP R&D, and Dr. Karen Kesler, AVP Operations, will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Life Sciences Network marcus evans
Presentation by Andreas Grauer, MD, Executive Medical Director, Global Development Leader, Amgen at the marcus evans Evolution Summit Fall 2015 in Las VegasDrug Discovery Method (Bioinformatics)
The document discusses drug design and the drug development process. It describes the two main types of drug design: ligand-based drug design, which relies on knowledge of molecules that bind to the biological target, and structure-based drug design, which models the 3D structure of a protein target. The drug development process involves six main stages: hit identification, pre-clinical studies, manufacturing, clinical trials, regulatory evaluation, and marketing. Overall, drug discovery and development is a complex, expensive process that can take 15 years from initial screening to FDA approval and market launch.
Lionberger gpha-2015
This document summarizes a presentation given by Dr. Robert Lionberger on the FDA's Office of Generic Drugs' (OGD) regulatory science priorities and accomplishments under the Generic Drug User Fee Amendments of 2012 (GDUFA). It introduces the Office of Research and Standards and discusses their work establishing equivalence standards and evaluating generic drugs, with a focus on five priority areas - post-market evaluation, complex products, locally-acting drugs, therapeutic equivalence standards, and computational tools. Updates on research projects, guidances, and interactions with industry are provided. The goal of the regulatory science program is to facilitate generic drug development and ensure therapeutic equivalence.
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
The document discusses pharmaceutical development and design according to ICH Q8 guidelines. It emphasizes using prior knowledge to establish a quality target product profile that defines the essential characteristics needed for safety, efficacy and intended use. Critical quality attributes are identified through risk assessment and studies that link material attributes to product performance. A control strategy is developed and includes designing a robust formulation and manufacturing process within a defined design space to consistently produce the desired quality product. The process emphasizes continual improvement and management of product knowledge throughout the lifecycle.
FDA applications in a nutshell
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
This presentation discusses integrated strategies for overcoming formulation challenges in drug development. It describes Quotient Sciences' approach of integrating formulation development, clinical testing, and manufacturing to accelerate programs and reduce costs. Examples are provided of enhancing solubility for poorly soluble drugs, developing modified release formulations, selecting formulations for first-in-human studies, and formulating peptides for oral delivery. The benefits of this integrated approach include timelines accelerated by over 12 months, significant cost savings, and a greater likelihood of success.
The Role of RWE in Drug Development_4Jun2015_final
This document discusses how real-world evidence (RWE) can be incorporated earlier and more broadly in the drug development process. It proposes a revised model where RWE is used from early research through commercialization to inform target profiles, messaging on unmet needs, and clinical trial design. Specifically, it suggests using RWE to "stress test" enrollment projections and identify referral sources. The document also advocates for moving beyond observational research to conduct cluster-randomized real-world experiments addressing outcomes important to payers and patients like treatment patterns and costs.
The assessed listed medicines pathway
This document discusses the assessed listed medicines pathway, a new pathway established under recommendations from an Australian medicines review. It provides three options for sponsors to list complementary medicines in Australia, including an option where sponsors can submit evidence of a product's efficacy to the Therapeutic Goods Administration (TGA) for pre-market assessment and be provided an AUSTL(A) number and ability to note the product was independently assessed. Key requirements and features of this pathway include sponsors submitting evidence of a product's intermediate-level indications, quality, safety and efficacy. The TGA will assess the evidence and product label before listing.
Multi criteria value-maximization methods for the prioritization of r&d inves...
This document discusses the need for systematically prioritizing limited resources for R&D investments in global health product development. It notes that certain diseases, products, R&D areas, and actors are in need of prioritization due to scarce funding. A multi-criteria decision analysis tool is proposed to help assess optimal R&D priority setting and investment decisions by considering various stakeholder concerns, objectives, and criteria. The document outlines a project to develop such a tool through establishing conceptual and methodological frameworks, conducting a global survey, and testing the tool at multiple levels of decision making.
4 Dr Jian Wang Health Canada
4 Dr Jian Wang Health CanadaInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Health Canada's Clinical Evaluation Division chief Jian Wang presented on clinical data requirements and key issues for market authorization of biotherapeutics. Wang discussed Health Canada's international collaborations and highlighted regulatory authorities' decision-making based on efficacy and safety. He outlined submission data requirements including quality, non-clinical, clinical, and risk management data. Wang also reviewed key clinical trial design considerations and common efficacy and safety issues with biologics. He emphasized that benefit-risk assessments are context-specific and can lead different regulatory decisions in different jurisdictions based on the same data.Application for New Drug Discovery (NDD) according to USFDA guidelines
The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
How and When to Kill a Program in New Product Planning
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Fundamental of-product-development
This document discusses key aspects of product development for pharmaceutical products. It covers stages of product development including drug discovery, formulation development, process research and development, analytical research, toxicology testing, and clinical trials. It discusses important considerations for product design such as target product profiles, design specifications, commercial factors, technical risks, safety, intellectual property, and environmental impacts. Methods for testing drug-excipient compatibility like DSC, chromatography, and microscopy are also summarized. The importance of pilot plant scale up is discussed to help identify issues prior to full production.
Jennifer maguire and karen bernard
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
IriSys Profile Presentation widescreen V.2.3
IRISYS is a pharmaceutical contract development and manufacturing organization founded in 1996 that offers services from preclinical formulation development through commercial manufacturing. It has extensive experience working with a wide range of clients, including small biotechs and large pharmaceutical companies. IRISYS has state-of-the-art facilities inspected by the FDA and is compliant with cGMP regulations. It has expertise in developing formulations across multiple dosage forms and technologies to meet various drug properties and delivery objectives.
PHARMACEUTICS.pptx
This document provides an introduction to pharmaceutics, which is concerned with the preparation and use of medicinal drugs. It discusses key topics including:
- The sources of drugs, pharmacology analysis, and active ingredients
- The design and manufacture of dosage forms, which combine active ingredients with excipients to facilitate drug delivery
- Quality assurance processes to ensure safe and effective drug production in a consistent manner
- The six main areas of pharmaceutics including physical chemistry principles, biopharmaceutics, dosage form design, manufacturing processes, sterilization, and product testing
- Factors considered in dosage form design like drug properties, administration route requirements, and therapeutic indications
Drug development team
Drug discovery project team, preclinical drug development project team, clinical drug development team
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
The document discusses regulatory requirements for drug approval. It covers the drug development process including non-clinical and clinical development teams. The non-clinical team conducts pre-clinical studies in animals to evaluate efficacy, safety, and viability of manufacturing. Clinical trials have multiple phases to test drugs on humans. A New Drug Application is submitted to regulatory authorities for marketing approval and includes preclinical and clinical data. The drug development process takes 10-12 years and involves interactions between scientific disciplines.
Ähnlich wie Steps Involved in Pharmaceutical Tablet Development (20)
Software Used In Formulation Design Process (Pharmaceutics).Pdf
Software Used In Formulation Design Process (Pharmaceutics).Pdf
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Protocol Design & Development: What You Need to Know to Ensure a Successful S...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
presentation-regulators-perspective-session-2-keith-pugh_en.pdf
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
OVERCOMING COMPLEX FORMULATION CHALLENGES FOR SMALL MOLECULES & PEPTIDES
The Role of RWE in Drug Development_4Jun2015_final
The Role of RWE in Drug Development_4Jun2015_final
Multi criteria value-maximization methods for the prioritization of r&d inves...
Multi criteria value-maximization methods for the prioritization of r&d inves...
Application for New Drug Discovery (NDD) according to USFDA guidelines
Application for New Drug Discovery (NDD) according to USFDA guidelines
How and When to Kill a Program in New Product Planning
How and When to Kill a Program in New Product Planning
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
regulatory requirements for drug approval ( IP-2 / UNIT -3 )
Kürzlich hochgeladen
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
Journal Article Review on Rasamanikya
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
This quiz was conducted as a promotional event for the 2024 Annual Meet of Kerala Chapter of API.
More than 20 participants took part everyday !
Histololgy of Female Reproductive System.pptx
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Hemodialysis: Chapter 4, Dialysate Circuit - Dr.Gawad
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Role of Mukta Pishti in the Management of Hyperthyroidism
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
The Nervous and Chemical Regulation of Respiration
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Kürzlich hochgeladen (20)
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
Hemodialysis: Chapter 4, Dialysate Circuit - Dr.Gawad
Hemodialysis: Chapter 4, Dialysate Circuit - Dr.Gawad
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis - Definition , Evaluation and Management .pdf
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Role of Mukta Pishti in the Management of Hyperthyroidism
Role of Mukta Pishti in the Management of Hyperthyroidism
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
The Nervous and Chemical Regulation of Respiration
The Nervous and Chemical Regulation of Respiration
Steps Involved in Pharmaceutical Tablet Development
- 1. Steps In the Development of a Tablet Formulation Sandip Gite, MTech, PhD(Pharmaceutics) 1
- 2. 2 Research Areas: • Solid Oral Dosage forms • Sterile Dosage forms • Oral solutions • NDDS • Ocular Dosage Forms
- 3. Steps In the Development of a Tablet Formulation 3 Define Objectives Literature Review Preformulation Studies Select Excipients Formulation Design Compatibility Studies Analytical Method Development Prototype Development Evaluation of Prototypes Scale-Up Stability Studies Regulatory Compliance Clinical Trials Scale-Up for Commercial Production (Exhibit/Reg Batches) Post-Market Surveillance
- 4. Define Objectives • Clearly outline the objectives of the tablet formulation including the desired therapeutic effect, target patient population, and any specific formulation requirements. 4
- 5. 5
- 6. 6
- 7. 7
- 8. 8
- 9. 9