SlideShare ist ein Scribd-Unternehmen logo

The role of dissolution in the demonstration of bioequivalence

•
•
I
inemet

PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com Abstract is available at http://www.pharmaconnectme.com

TechnologieBusiness
1 von 68
THE ROLE OF DISSOLUTION IN THE DEMONSTRATION OF BIOEQUIVALENCE Prof.Dr.Nevin ÇELEBİ Gazi University Faculty of Pharmacy Department of Pharmaceutical Technology PharmaCon 2007-Dubrovnik
OUTLINE ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution ,[object Object]
Dissolution rate ,[object Object]
 
[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution test ,[object Object],[object Object]
Dissolution test ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution Test Equipment ,[object Object],[object Object],[object Object],[object Object],[object Object]
Official dissolution apparatus ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 1 - Basket ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Klein S., Hands-on-Dissollution workshop,İstanbul,2005
USP apparatus 1 - Basket ,[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 2 - Paddle ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 3 – Reciprocating cylinder ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 4 – Flow-Through Cell ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 5 – Paddle over disk ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object]
Dissolution/In vitro Release Testing-Important Tool ,[object Object],[object Object],[object Object],[object Object],[object Object]
Role of Dissolution Testing in Regulating Pharmaceuticals ,[object Object],[object Object],[object Object]
Policy Related Dissolution BA/BE Guidances ,[object Object],[object Object],[object Object],[object Object],http://www.fda.gov/cder/guidance/index.htm
Setting Dissolution Specification (FDA) ,[object Object],[object Object],[object Object]
Setting Dissolution Specification(FDA) ,[object Object],[object Object],[object Object]
Guidance of BY/BE (EMEA2001) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Guidance of BY/BE (EMEA2001) ,[object Object],[object Object],[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution Specifications (FDA) ,[object Object],[object Object],[object Object],[object Object]
Dissolution Specifications (FDA) ,[object Object],[object Object],[object Object],[object Object]
 
The comparison of dissolution profiles ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The comparison of dissolution profiles ,[object Object],[object Object]
Difference factor (f 1 ) n is the number of time points R t is the dissolution value of the reference batch at time t, and T t is the dissolution value of the test batch at time t.
Similarity factor (f 2 ) n is the number of time points Rt is the mean percent drug dissolved of e.g a reference product, Tt is the mean percent drug dissolved of e.g a test product
Similarity factor (f 2 ) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Similarity factor (f 2 ) ,[object Object]
[object Object]
Biopharmaceutics Classification System(BCS) ,[object Object],[object Object]
According to BCS,drug substances are classified as follows: ,[object Object],BCS for Immediate Release (IR) products Case by case Low Low IV Permeability Low High III Dissolution High Low II Gastric Emptying High High I Absorption rate control Permeability Solubility Class
BCS (Cont’d) ,[object Object],[object Object]
BCS (Cont’d) ,[object Object],[object Object],[object Object]
BCS (Cont’d) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Reference product-EU origin ,[object Object]
Reference product-EU origin ,[object Object]
Graffner C., Eur.Pharm.Sci.,29,288-298 (2006)
Summary ,[object Object]
[object Object],[object Object]
Dissolution ,[object Object]
Dissolution ,[object Object],[object Object]
Dissolution ,[object Object]
Dissolution ,[object Object]
Dissolution test ,[object Object],[object Object]
Dissolution Guidance ,[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective ,[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
[object Object]
Graffner C., Eur.Pharm.Sci.,29,288-298 (2006)

Empfohlen

Biowaiver
BiowaiverBiowaiver
Biowaiver
Ahmadreza Barazesh
 
Dissolution - Selection of Dissolution Media
Dissolution - Selection of Dissolution MediaDissolution - Selection of Dissolution Media
Dissolution - Selection of Dissolution Media
Sagar Savale
 
Dissolution and drug release testing
Dissolution and drug release testingDissolution and drug release testing
Dissolution and drug release testing
Roshan Bodhe
 
Comparision of dissolution profile
Comparision of dissolution profileComparision of dissolution profile
Comparision of dissolution profile
Ranjith Karanam
 
Similarity and difference factors of dissolution
Similarity and difference factors of dissolutionSimilarity and difference factors of dissolution
Similarity and difference factors of dissolution
Jessica Fernandes
 
Four Levels of In-Vitro-In-Vivo Correlation
Four Levels of In-Vitro-In-Vivo CorrelationFour Levels of In-Vitro-In-Vivo Correlation
Four Levels of In-Vitro-In-Vivo Correlation
Bhaswat Chakraborty
 
Dissolution chapter
Dissolution chapter Dissolution chapter
Dissolution chapter
Arshad Khan
 
Bioequivalence Studies
Bioequivalence StudiesBioequivalence Studies
Bioequivalence Studies
wonderingsoul114
 

Empfohlen

Biowaiver
BiowaiverBiowaiver
Biowaiver
Ahmadreza Barazesh
 
Dissolution - Selection of Dissolution Media
Dissolution - Selection of Dissolution MediaDissolution - Selection of Dissolution Media
Dissolution - Selection of Dissolution Media
Sagar Savale
 
Dissolution and drug release testing
Dissolution and drug release testingDissolution and drug release testing
Dissolution and drug release testing
Roshan Bodhe
 
Comparision of dissolution profile
Comparision of dissolution profileComparision of dissolution profile
Comparision of dissolution profile
Ranjith Karanam
 
Similarity and difference factors of dissolution
Similarity and difference factors of dissolutionSimilarity and difference factors of dissolution
Similarity and difference factors of dissolution
Jessica Fernandes
 
Four Levels of In-Vitro-In-Vivo Correlation
Four Levels of In-Vitro-In-Vivo CorrelationFour Levels of In-Vitro-In-Vivo Correlation
Four Levels of In-Vitro-In-Vivo Correlation
Bhaswat Chakraborty
 
Dissolution chapter
Dissolution chapter Dissolution chapter
Dissolution chapter
Arshad Khan
 
Bioequivalence Studies
Bioequivalence StudiesBioequivalence Studies
Bioequivalence Studies
wonderingsoul114
 
Dissolution f1 and f2 Analysis and IVIVC
Dissolution f1 and f2 Analysis and IVIVCDissolution f1 and f2 Analysis and IVIVC
Dissolution f1 and f2 Analysis and IVIVC
Cipla Pharmaceuticals
 
Biowaivers
BiowaiversBiowaivers
Biowaivers
shikha singh
 
Developing a discriminating dissolution
Developing a discriminating dissolutionDeveloping a discriminating dissolution
Developing a discriminating dissolution
V.Maheswaran ,
 
Dissolution profile comparison
Dissolution profile comparisonDissolution profile comparison
Dissolution profile comparison
Mohammad Imran
 
Biowaivers
Biowaivers Biowaivers
Biowaivers
Institute of Pharmacy, Nirma University
 
IN VITRO - IN VIVO CORRELATION
IN VITRO - IN VIVO CORRELATIONIN VITRO - IN VIVO CORRELATION
IN VITRO - IN VIVO CORRELATION
N Anusha
 
Dissolution test apparatus
Dissolution test apparatus Dissolution test apparatus
Dissolution test apparatus
Sagar Savale
 
Dissolution and In Vitro In Vivo Correlation (IVIVC)
Dissolution and In Vitro In Vivo Correlation (IVIVC)Dissolution and In Vitro In Vivo Correlation (IVIVC)
Dissolution and In Vitro In Vivo Correlation (IVIVC)
Jaspreet Guraya
 
IVIVC
IVIVCIVIVC
IVIVC
Mohammad Imran
 
Dissolution testing
Dissolution testingDissolution testing
Dissolution testing
Gaurav Kr
 
DISSOLUTION
DISSOLUTIONDISSOLUTION
DISSOLUTION
Roshan Bodhe
 
DISSOLUTION PARAMETERS AND ITS APPARATUS
DISSOLUTION PARAMETERS AND ITS APPARATUSDISSOLUTION PARAMETERS AND ITS APPARATUS
DISSOLUTION PARAMETERS AND ITS APPARATUS
ROHIT
 
drug dissolution
drug dissolutiondrug dissolution
drug dissolution
Malla Reddy College of Pharmacy
 
Dissolution
DissolutionDissolution
Dissolution
Malla Reddy College of Pharmacy
 
Dissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release productsDissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release products
Md Fiaz
 
GUIDELINES FOR DISSOLUTION TESTING
GUIDELINES FOR DISSOLUTION TESTINGGUIDELINES FOR DISSOLUTION TESTING
GUIDELINES FOR DISSOLUTION TESTING
Sagar Savale
 
In vitro Dissolution Testing Models
In vitro Dissolution Testing ModelsIn vitro Dissolution Testing Models
In vitro Dissolution Testing Models
Ameer Ahmed
 
Drug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalenceDrug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalence
DipakKumarGupta3
 
Regulatory aspects of biowaiver
Regulatory aspects of biowaiverRegulatory aspects of biowaiver
Regulatory aspects of biowaiver
sonian22
 
In vitro In vivo correlation
In vitro In vivo correlationIn vitro In vivo correlation
In vitro In vivo correlation
Mahewash Sana Pathan
 
Dissolution
DissolutionDissolution
Dissolution
wonderingsoul114
 
Dissolution
DissolutionDissolution
Dissolution
NILESH JAWALKAR
 

Weitere ähnliche Inhalte

Was ist angesagt?

Dissolution testing
Dissolution testingDissolution testing
Dissolution testing
Gaurav Kr
 
Dissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release productsDissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release products
Md Fiaz
 

Was ist angesagt? (20)

Dissolution f1 and f2 Analysis and IVIVC
Dissolution f1 and f2 Analysis and IVIVCDissolution f1 and f2 Analysis and IVIVC
Dissolution f1 and f2 Analysis and IVIVC
 
Biowaivers
BiowaiversBiowaivers
Biowaivers
 
Developing a discriminating dissolution
Developing a discriminating dissolutionDeveloping a discriminating dissolution
Developing a discriminating dissolution
 
Dissolution profile comparison
Dissolution profile comparisonDissolution profile comparison
Dissolution profile comparison
 
Biowaivers
Biowaivers Biowaivers
Biowaivers
 
IN VITRO - IN VIVO CORRELATION
IN VITRO - IN VIVO CORRELATIONIN VITRO - IN VIVO CORRELATION
IN VITRO - IN VIVO CORRELATION
 
Dissolution test apparatus
Dissolution test apparatus Dissolution test apparatus
Dissolution test apparatus
 
Dissolution and In Vitro In Vivo Correlation (IVIVC)
Dissolution and In Vitro In Vivo Correlation (IVIVC)Dissolution and In Vitro In Vivo Correlation (IVIVC)
Dissolution and In Vitro In Vivo Correlation (IVIVC)
 
IVIVC
IVIVCIVIVC
IVIVC
 
Dissolution testing
Dissolution testingDissolution testing
Dissolution testing
 
DISSOLUTION
DISSOLUTIONDISSOLUTION
DISSOLUTION
 
DISSOLUTION PARAMETERS AND ITS APPARATUS
DISSOLUTION PARAMETERS AND ITS APPARATUSDISSOLUTION PARAMETERS AND ITS APPARATUS
DISSOLUTION PARAMETERS AND ITS APPARATUS
 
drug dissolution
drug dissolutiondrug dissolution
drug dissolution
 
Dissolution
DissolutionDissolution
Dissolution
 
Dissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release productsDissolution testing conventional and controlled release products
Dissolution testing conventional and controlled release products
 
GUIDELINES FOR DISSOLUTION TESTING
GUIDELINES FOR DISSOLUTION TESTINGGUIDELINES FOR DISSOLUTION TESTING
GUIDELINES FOR DISSOLUTION TESTING
 
In vitro Dissolution Testing Models
In vitro Dissolution Testing ModelsIn vitro Dissolution Testing Models
In vitro Dissolution Testing Models
 
Drug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalenceDrug product performance , in vivo: bioavailability and bioequivalence
Drug product performance , in vivo: bioavailability and bioequivalence
 
Regulatory aspects of biowaiver
Regulatory aspects of biowaiverRegulatory aspects of biowaiver
Regulatory aspects of biowaiver
 
In vitro In vivo correlation
In vitro In vivo correlationIn vitro In vivo correlation
In vitro In vivo correlation
 

Andere mochten auch

Pharmaceutical suspension
Pharmaceutical suspensionPharmaceutical suspension
Pharmaceutical suspension
Istiaque Ahmed
 
Facilities in RIPER
Facilities in RIPERFacilities in RIPER
Facilities in RIPER
DR. Venkat S. Karra, Ph.D.
 
Use of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
Use of Solid Core Chromatography for the Analysis of Pharmaceutical CompoundsUse of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
Use of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
Chromatography & Mass Spectrometry Solutions
 
Dissolution study of solids and suspension.ppt
Dissolution study of solids and suspension.pptDissolution study of solids and suspension.ppt
Dissolution study of solids and suspension.ppt
Chaitanya Ghodake
 
23117 copy of oral solid dosage forms
23117 copy of oral solid dosage forms23117 copy of oral solid dosage forms
23117 copy of oral solid dosage forms
Patel Parth
 
Osmotic drug delivery system
Osmotic drug delivery systemOsmotic drug delivery system
Osmotic drug delivery system
swapna porandla
 

Andere mochten auch (20)

Dissolution
DissolutionDissolution
Dissolution
 
Dissolution
DissolutionDissolution
Dissolution
 
Validation of solid dosage forms in pharmaceutical industries
Validation of solid dosage forms in pharmaceutical industries Validation of solid dosage forms in pharmaceutical industries
Validation of solid dosage forms in pharmaceutical industries
 
Oral Soild Dosage - Tablet manufacturing flow
Oral Soild Dosage - Tablet manufacturing flowOral Soild Dosage - Tablet manufacturing flow
Oral Soild Dosage - Tablet manufacturing flow
 
Pharmaceutical Solid Form
Pharmaceutical Solid FormPharmaceutical Solid Form
Pharmaceutical Solid Form
 
Pharmaceutical suspension
Pharmaceutical suspensionPharmaceutical suspension
Pharmaceutical suspension
 
DISSOLUTION TESTING APPARATUS
DISSOLUTION TESTING APPARATUSDISSOLUTION TESTING APPARATUS
DISSOLUTION TESTING APPARATUS
 
Pharmaceutical Syrup
Pharmaceutical SyrupPharmaceutical Syrup
Pharmaceutical Syrup
 
Surfactants and their applications in pharmaceutical dosage form
Surfactants and their applications in pharmaceutical dosage formSurfactants and their applications in pharmaceutical dosage form
Surfactants and their applications in pharmaceutical dosage form
 
Dissolution
DissolutionDissolution
Dissolution
 
John O'Halloran, Solid State Pharmaceutical Cluster
John O'Halloran, Solid State Pharmaceutical ClusterJohn O'Halloran, Solid State Pharmaceutical Cluster
John O'Halloran, Solid State Pharmaceutical Cluster
 
Facilities in RIPER
Facilities in RIPERFacilities in RIPER
Facilities in RIPER
 
Use of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
Use of Solid Core Chromatography for the Analysis of Pharmaceutical CompoundsUse of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
Use of Solid Core Chromatography for the Analysis of Pharmaceutical Compounds
 
Dissolution study of solids and suspension.ppt
Dissolution study of solids and suspension.pptDissolution study of solids and suspension.ppt
Dissolution study of solids and suspension.ppt
 
Semisolid
SemisolidSemisolid
Semisolid
 
Development and evaluation of xyloglucan matrix release tabs contaning glipizide
Development and evaluation of xyloglucan matrix release tabs contaning glipizideDevelopment and evaluation of xyloglucan matrix release tabs contaning glipizide
Development and evaluation of xyloglucan matrix release tabs contaning glipizide
 
23117 copy of oral solid dosage forms
23117 copy of oral solid dosage forms23117 copy of oral solid dosage forms
23117 copy of oral solid dosage forms
 
Dissolution presentation by subhakanta Dhal
Dissolution presentation by subhakanta DhalDissolution presentation by subhakanta Dhal
Dissolution presentation by subhakanta Dhal
 
Osmotic drug delivery system
Osmotic drug delivery systemOsmotic drug delivery system
Osmotic drug delivery system
 
Hari krishna
Hari krishnaHari krishna
Hari krishna
 

Ähnlich wie The role of dissolution in the demonstration of bioequivalence

Dissolution Test development in regard to bioequivalence
Dissolution Test development in regard to bioequivalenceDissolution Test development in regard to bioequivalence
Dissolution Test development in regard to bioequivalence
anezlin
 

Ähnlich wie The role of dissolution in the demonstration of bioequivalence (20)

DissolTesting.PPT diffrent dissolution testing
DissolTesting.PPT diffrent dissolution testingDissolTesting.PPT diffrent dissolution testing
DissolTesting.PPT diffrent dissolution testing
 
Claim & Reasonable Probability (Part 2)
Claim & Reasonable Probability (Part 2)Claim & Reasonable Probability (Part 2)
Claim & Reasonable Probability (Part 2)
 
Disolution best
Disolution bestDisolution best
Disolution best
 
DRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITRODRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITRO
 
Dissolution Test development in regard to bioequivalence
Dissolution Test development in regard to bioequivalenceDissolution Test development in regard to bioequivalence
Dissolution Test development in regard to bioequivalence
 
Dissolution_Technique.ppt
Dissolution_Technique.pptDissolution_Technique.ppt
Dissolution_Technique.ppt
 
Drug product perfomance in vitro
Drug product perfomance in vitroDrug product perfomance in vitro
Drug product perfomance in vitro
 
Drug product performance (joel)
Drug product performance (joel)Drug product performance (joel)
Drug product performance (joel)
 
In vivo in vitro correlation - copy
In vivo in vitro correlation - copyIn vivo in vitro correlation - copy
In vivo in vitro correlation - copy
 
Dissolution -final
Dissolution -finalDissolution -final
Dissolution -final
 
DRUG DISSOLUTION, BIO-AVAILABILITY AND IVIVC DEVELOPMENT
DRUG DISSOLUTION, BIO-AVAILABILITY AND IVIVC DEVELOPMENTDRUG DISSOLUTION, BIO-AVAILABILITY AND IVIVC DEVELOPMENT
DRUG DISSOLUTION, BIO-AVAILABILITY AND IVIVC DEVELOPMENT
 
Bioequivalence biowaiver and ivivc studies 2014 new
Bioequivalence biowaiver and ivivc studies 2014 newBioequivalence biowaiver and ivivc studies 2014 new
Bioequivalence biowaiver and ivivc studies 2014 new
 
in vivo in vitro
in vivo in vitroin vivo in vitro
in vivo in vitro
 
Biopharmaceutic considerations in drug product design and in
Biopharmaceutic considerations in drug product design and inBiopharmaceutic considerations in drug product design and in
Biopharmaceutic considerations in drug product design and in
 
Study submission of Bioequivalence and Drug review Process, BCS (BIOPHARMACEU...
Study submission of Bioequivalence and Drug review Process, BCS (BIOPHARMACEU...Study submission of Bioequivalence and Drug review Process, BCS (BIOPHARMACEU...
Study submission of Bioequivalence and Drug review Process, BCS (BIOPHARMACEU...
 
Biowaiver
BiowaiverBiowaiver
Biowaiver
 
validation of disso method 2.pdf
validation of disso method 2.pdfvalidation of disso method 2.pdf
validation of disso method 2.pdf
 
B
BB
B
 
Generic-Drugs-and-Bioequivalence---Presentation(1)(1)(1).pdf
Generic-Drugs-and-Bioequivalence---Presentation(1)(1)(1).pdfGeneric-Drugs-and-Bioequivalence---Presentation(1)(1)(1).pdf
Generic-Drugs-and-Bioequivalence---Presentation(1)(1)(1).pdf
 
In Vitro Drug Product Performance.ppt
In Vitro Drug Product Performance.pptIn Vitro Drug Product Performance.ppt
In Vitro Drug Product Performance.ppt
 

Mehr von inemet

Mehr von inemet (20)

EUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical SciencesEUFEPS and European Initiatives in Pharmaceutical Sciences
EUFEPS and European Initiatives in Pharmaceutical Sciences
 
Legal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalenceLegal requirements for generics and abridged products and bioequivalence
Legal requirements for generics and abridged products and bioequivalence
 
Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...Significance of BA/BE studies in drug research and evaluation of different as...
Significance of BA/BE studies in drug research and evaluation of different as...
 
Future trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnologyFuture trends and perspectives in modern pharmaceutical biotechnology
Future trends and perspectives in modern pharmaceutical biotechnology
 
Focussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enoughFocussing on cytotoxic treatment alone is not enough
Focussing on cytotoxic treatment alone is not enough
 
Bioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfallsBioavailability and bioequivalence – problems and pitfalls
Bioavailability and bioequivalence – problems and pitfalls
 
Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?Quo Vadis EU Pharmacy?
Quo Vadis EU Pharmacy?
 
Education - Do we have a choice?
Education - Do we have a choice?Education - Do we have a choice?
Education - Do we have a choice?
 
The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...The truth between the lines – Community pharmacists in improving the health o...
The truth between the lines – Community pharmacists in improving the health o...
 
BY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUEBY HELPING PEOPLE MY DREAM IS BECOMING TRUE
BY HELPING PEOPLE MY DREAM IS BECOMING TRUE
 
POSTGENETICS MEDICINE
POSTGENETICS MEDICINEPOSTGENETICS MEDICINE
POSTGENETICS MEDICINE
 
SHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERSSHARING VISION – TOWARDS BIOMEDICINE PARTNERS
SHARING VISION – TOWARDS BIOMEDICINE PARTNERS
 
Sightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forwardSightseeing Pharmacy practice - The way forward
Sightseeing Pharmacy practice - The way forward
 
EU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticalsEU telematics in the regulation of pharmaceuticals
EU telematics in the regulation of pharmaceuticals
 
Generics and Biogenerics
Generics and BiogenericsGenerics and Biogenerics
Generics and Biogenerics
 
Pharmacovigilance Workshop
Pharmacovigilance WorkshopPharmacovigilance Workshop
Pharmacovigilance Workshop
 
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG...
 
Making knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency MapsMaking knowledge matter: The Skills Inventory and the Competency Maps
Making knowledge matter: The Skills Inventory and the Competency Maps
 
Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats Trigger Point – Self-medication: Patients in white coats
Trigger Point – Self-medication: Patients in white coats
 
Pharmacy in croatia - A short overview
Pharmacy in croatia - A short overviewPharmacy in croatia - A short overview
Pharmacy in croatia - A short overview
 

Kürzlich hochgeladen

A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?
Igalia
 
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time AutomationFrom Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
Safe Software
 
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Miguel Araújo
 
TrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
TrustArc Webinar - Unlock the Power of AI-Driven Data DiscoveryTrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
TrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
TrustArc
 
TrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
TrustArc Webinar - Stay Ahead of US State Data Privacy Law DevelopmentsTrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
TrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
TrustArc
 

Kürzlich hochgeladen (20)

A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?A Year of the Servo Reboot: Where Are We Now?
A Year of the Servo Reboot: Where Are We Now?
 
GenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day PresentationGenCyber Cyber Security Day Presentation
GenCyber Cyber Security Day Presentation
 
Exploring the Future Potential of AI-Enabled Smartphone Processors
Exploring the Future Potential of AI-Enabled Smartphone ProcessorsExploring the Future Potential of AI-Enabled Smartphone Processors
Exploring the Future Potential of AI-Enabled Smartphone Processors
 
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time AutomationFrom Event to Action: Accelerate Your Decision Making with Real-Time Automation
From Event to Action: Accelerate Your Decision Making with Real-Time Automation
 
Scaling API-first – The story of a global engineering organization
Scaling API-first – The story of a global engineering organizationScaling API-first – The story of a global engineering organization
Scaling API-first – The story of a global engineering organization
 
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
Mastering MySQL Database Architecture: Deep Dive into MySQL Shell and MySQL R...
 
Finology Group – Insurtech Innovation Award 2024
Finology Group – Insurtech Innovation Award 2024Finology Group – Insurtech Innovation Award 2024
Finology Group – Insurtech Innovation Award 2024
 
The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024The 7 Things I Know About Cyber Security After 25 Years | April 2024
The 7 Things I Know About Cyber Security After 25 Years | April 2024
 
Developing An App To Navigate The Roads of Brazil
Developing An App To Navigate The Roads of BrazilDeveloping An App To Navigate The Roads of Brazil
Developing An App To Navigate The Roads of Brazil
 
🐬 The future of MySQL is Postgres 🐘
🐬 The future of MySQL is Postgres 🐘🐬 The future of MySQL is Postgres 🐘
🐬 The future of MySQL is Postgres 🐘
 
HTML Injection Attacks: Impact and Mitigation Strategies
HTML Injection Attacks: Impact and Mitigation StrategiesHTML Injection Attacks: Impact and Mitigation Strategies
HTML Injection Attacks: Impact and Mitigation Strategies
 
A Domino Admins Adventures (Engage 2024)
A Domino Admins Adventures (Engage 2024)A Domino Admins Adventures (Engage 2024)
A Domino Admins Adventures (Engage 2024)
 
Strategies for Landing an Oracle DBA Job as a Fresher
Strategies for Landing an Oracle DBA Job as a FresherStrategies for Landing an Oracle DBA Job as a Fresher
Strategies for Landing an Oracle DBA Job as a Fresher
 
TrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
TrustArc Webinar - Unlock the Power of AI-Driven Data DiscoveryTrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
TrustArc Webinar - Unlock the Power of AI-Driven Data Discovery
 
Real Time Object Detection Using Open CV
Real Time Object Detection Using Open CVReal Time Object Detection Using Open CV
Real Time Object Detection Using Open CV
 
How to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected WorkerHow to Troubleshoot Apps for the Modern Connected Worker
How to Troubleshoot Apps for the Modern Connected Worker
 
TrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
TrustArc Webinar - Stay Ahead of US State Data Privacy Law DevelopmentsTrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
TrustArc Webinar - Stay Ahead of US State Data Privacy Law Developments
 
2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...2024: Domino Containers - The Next Step. News from the Domino Container commu...
2024: Domino Containers - The Next Step. News from the Domino Container commu...
 
Boost Fertility New Invention Ups Success Rates.pdf
Boost Fertility New Invention Ups Success Rates.pdfBoost Fertility New Invention Ups Success Rates.pdf
Boost Fertility New Invention Ups Success Rates.pdf
 
Data Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt RobisonData Cloud, More than a CDP by Matt Robison
Data Cloud, More than a CDP by Matt Robison
 

The role of dissolution in the demonstration of bioequivalence

  • 1. THE ROLE OF DISSOLUTION IN THE DEMONSTRATION OF BIOEQUIVALENCE Prof.Dr.Nevin ÇELEBİ Gazi University Faculty of Pharmacy Department of Pharmaceutical Technology PharmaCon 2007-Dubrovnik
  • 2.
  • 3.
  • 4.
  • 5.  
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.  
  • 35.
  • 36.
  • 37. Difference factor (f 1 ) n is the number of time points R t is the dissolution value of the reference batch at time t, and T t is the dissolution value of the test batch at time t.
  • 38. Similarity factor (f 2 ) n is the number of time points Rt is the mean percent drug dissolved of e.g a reference product, Tt is the mean percent drug dissolved of e.g a test product
  • 39.
  • 40.
  • 41.
  • 42.
  • 43.
  • 44.
  • 45.
  • 46.
  • 47.
  • 48.
  • 49.
  • 50.
  • 52.
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58.
  • 59.
  • 60.
  • 61.
  • 62.
  • 63.
  • 64.
  • 65.
  • 66.
  • 67.