SlideShare ist ein Scribd-Unternehmen logo

Session 2 part 3

•Als PPT, PDF herunterladen•
•
P
plmiami
BusinessTechnologie
1 von 18
ICH S2: Genetic Toxicity ,[object Object],[object Object],[object Object],[object Object],[object Object]
Genetic Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ICH S7: Safety Pharmacology ,[object Object],[object Object],[object Object],[object Object]
Safety Pharmacology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Endpoints ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Endpoints (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Endpoints (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Endpoints (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Endpoints (cont.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tissues Examined ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ICH S3: Toxicokinetics - Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Must evaluate exposure in animals
Interpretation of Toxicology Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Interpretation of Toxicology Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How Much of an Exposure Multiple Do I Need? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Complete Toxicology Profile Preliminary Evaluation Genetic Toxicology Battery Acute Toxicology Subchronic Toxicology (14-day to 90-days) Chronic Toxicology (6-month to 12-month) Oncogenic Studies (2-year) Genetic Toxicology Kinetics Acute and Multidose Tox in vitro Tox Definitive toxicokinetics Reproductive and Developmental Tox (timing affected by inclusion of WCBP) Environmental Assessment Toxicology of major human metabolites Toxicology of degradation products Safety Pharmacology Dorato, M. A., Vodicnik, M. J. The Toxicologic Assessment of Pharmaceutical and Biotechnology Products. in Principles and Methods of Toxicology . Raven Press, 1994
Minimum For IND… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Empfohlen

Animal Experiments and Alternatives
Animal Experiments and AlternativesAnimal Experiments and Alternatives
Animal Experiments and AlternativesAndrew Knight
 
Alternative to animal studies
Alternative to animal studiesAlternative to animal studies
Alternative to animal studiespaulvitrion91
 
Assignment on Alternatives to Animal Screening Method
Assignment on Alternatives to Animal Screening MethodAssignment on Alternatives to Animal Screening Method
Assignment on Alternatives to Animal Screening MethodDeepak Kumar
 
Alternative methods to animal toxicity testing
Alternative methods to animal toxicity testingAlternative methods to animal toxicity testing
Alternative methods to animal toxicity testingSanchit Dhankhar
 
Pharmacological screening by harikesh maurya
Pharmacological screening by harikesh mauryaPharmacological screening by harikesh maurya
Pharmacological screening by harikesh mauryaHarikesh Maurya
 
Alternatives to animal experiments
Alternatives to animal experimentsAlternatives to animal experiments
Alternatives to animal experimentsRoopali Somani
 
Pravin fianl
Pravin fianlPravin fianl
Pravin fianlDr. Pravin Wahane
 
s.s.c (Alternative to animal study)
s.s.c (Alternative to animal study)s.s.c (Alternative to animal study)
s.s.c (Alternative to animal study)Sandip Chaudhari
 

Empfohlen

Animal Experiments and Alternatives
Animal Experiments and AlternativesAnimal Experiments and Alternatives
Animal Experiments and AlternativesAndrew Knight
 
Alternative to animal studies
Alternative to animal studiesAlternative to animal studies
Alternative to animal studiespaulvitrion91
 
Assignment on Alternatives to Animal Screening Method
Assignment on Alternatives to Animal Screening MethodAssignment on Alternatives to Animal Screening Method
Assignment on Alternatives to Animal Screening MethodDeepak Kumar
 
Alternative methods to animal toxicity testing
Alternative methods to animal toxicity testingAlternative methods to animal toxicity testing
Alternative methods to animal toxicity testingSanchit Dhankhar
 
Pharmacological screening by harikesh maurya
Pharmacological screening by harikesh mauryaPharmacological screening by harikesh maurya
Pharmacological screening by harikesh mauryaHarikesh Maurya
 
Alternatives to animal experiments
Alternatives to animal experimentsAlternatives to animal experiments
Alternatives to animal experimentsRoopali Somani
 
Pravin fianl
Pravin fianlPravin fianl
Pravin fianlDr. Pravin Wahane
 
s.s.c (Alternative to animal study)
s.s.c (Alternative to animal study)s.s.c (Alternative to animal study)
s.s.c (Alternative to animal study)Sandip Chaudhari
 
Toxicological studies
Toxicological studiesToxicological studies
Toxicological studiesRabeah Lookyoung
 
Alternatives to Animal Testing
Alternatives to Animal TestingAlternatives to Animal Testing
Alternatives to Animal TestingCognibrain Healthcare
 
Acute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animalsAcute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animalsSwaroopaNallabariki
 
Alternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusainAlternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusainVasaya Mohammadhusain
 
Animal experimentation
Animal experimentationAnimal experimentation
Animal experimentationJuan Antonio Sánchez Canales
 
Alternatives to animals in toxicity testing
Alternatives to animals in toxicity testingAlternatives to animals in toxicity testing
Alternatives to animals in toxicity testingSandhya Talla
 
Alternative animal experimentation technique
Alternative animal experimentation techniqueAlternative animal experimentation technique
Alternative animal experimentation techniqueKARNATAKA COLLEGE OF PHARMACY
 
Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )Deepak Joshi
 
Invivo pharmacology
Invivo pharmacologyInvivo pharmacology
Invivo pharmacologyKoppala RVS Chaitanya
 
Methods of Research
Methods of Research Methods of Research
Methods of Research Mohammad Elshawwa MD
 
Safety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt junSafety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt junMr. Sharad Khune
 
Toxicity Studies
Toxicity StudiesToxicity Studies
Toxicity StudiesSanman samova
 
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...International Journal of Technical Research & Application
 
Carcinogenicity testing
Carcinogenicity testingCarcinogenicity testing
Carcinogenicity testingsaravanan gunasekar
 
Toxicological studies and bioequivalence
Toxicological studies and bioequivalenceToxicological studies and bioequivalence
Toxicological studies and bioequivalencevishnugm
 
Introduction to toxicology
Introduction to toxicologyIntroduction to toxicology
Introduction to toxicologyManojKumar109262
 
Alternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptxAlternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptxDr.SIBI P ITTIYAVIRAH
 
Alternative methods to animal testing: review
Alternative methods to animal testing: reviewAlternative methods to animal testing: review
Alternative methods to animal testing: reviewankit sharma
 
ALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELSALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELSHarish Nakka
 
Reproductive toxicology studies
Reproductive toxicology studiesReproductive toxicology studies
Reproductive toxicology studieskusuma khushi
 
Toxicity
ToxicityToxicity
ToxicityVernie Gamit
 
Sequenced taged sites (sts)
Sequenced taged sites (sts)Sequenced taged sites (sts)
Sequenced taged sites (sts)DHANRAJ GIRIMAL
 

Weitere ähnliche Inhalte

Was ist angesagt?

Acute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animalsAcute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animalsSwaroopaNallabariki
 
Alternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusainAlternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusainVasaya Mohammadhusain
 
Alternatives to animals in toxicity testing
Alternatives to animals in toxicity testingAlternatives to animals in toxicity testing
Alternatives to animals in toxicity testingSandhya Talla
 
Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )Deepak Joshi
 
Safety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt junSafety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt junMr. Sharad Khune
 
Toxicological studies and bioequivalence
Toxicological studies and bioequivalenceToxicological studies and bioequivalence
Toxicological studies and bioequivalencevishnugm
 
Introduction to toxicology
Introduction to toxicologyIntroduction to toxicology
Introduction to toxicologyManojKumar109262
 
Alternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptxAlternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptxDr.SIBI P ITTIYAVIRAH
 
Alternative methods to animal testing: review
Alternative methods to animal testing: reviewAlternative methods to animal testing: review
Alternative methods to animal testing: reviewankit sharma
 
ALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELSALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELSHarish Nakka
 
Reproductive toxicology studies
Reproductive toxicology studiesReproductive toxicology studies
Reproductive toxicology studieskusuma khushi
 

Was ist angesagt? (20)

Toxicological studies
Toxicological studiesToxicological studies
Toxicological studies
 
Alternatives to Animal Testing
Alternatives to Animal TestingAlternatives to Animal Testing
Alternatives to Animal Testing
 
Acute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animalsAcute and chronic toxicity studies in animals
Acute and chronic toxicity studies in animals
 
Alternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusainAlternatives to animal screening methods p'screening. mohammadhusain
Alternatives to animal screening methods p'screening. mohammadhusain
 
Animal experimentation
Animal experimentationAnimal experimentation
Animal experimentation
 
Alternatives to animals in toxicity testing
Alternatives to animals in toxicity testingAlternatives to animals in toxicity testing
Alternatives to animals in toxicity testing
 
Alternative animal experimentation technique
Alternative animal experimentation techniqueAlternative animal experimentation technique
Alternative animal experimentation technique
 
Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )Alternate animal experiments ( Basic Introduction )
Alternate animal experiments ( Basic Introduction )
 
Invivo pharmacology
Invivo pharmacologyInvivo pharmacology
Invivo pharmacology
 
Methods of Research
Methods of Research Methods of Research
Methods of Research
 
Safety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt junSafety evaluation of algae...final ppt jun
Safety evaluation of algae...final ppt jun
 
Toxicity Studies
Toxicity StudiesToxicity Studies
Toxicity Studies
 
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...
THERAPY OF PULMONARY TUBERCULOSIS WITH MULTIDRUG-RESISTANT MYCOBACTERIUM TUBE...
 
Carcinogenicity testing
Carcinogenicity testingCarcinogenicity testing
Carcinogenicity testing
 
Toxicological studies and bioequivalence
Toxicological studies and bioequivalenceToxicological studies and bioequivalence
Toxicological studies and bioequivalence
 
Introduction to toxicology
Introduction to toxicologyIntroduction to toxicology
Introduction to toxicology
 
Alternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptxAlternatives to animalexperiments.pptx
Alternatives to animalexperiments.pptx
 
Alternative methods to animal testing: review
Alternative methods to animal testing: reviewAlternative methods to animal testing: review
Alternative methods to animal testing: review
 
ALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELSALTERNATIVES TO ANIMAL MODELS
ALTERNATIVES TO ANIMAL MODELS
 
Reproductive toxicology studies
Reproductive toxicology studiesReproductive toxicology studies
Reproductive toxicology studies
 

Andere mochten auch

Sequenced taged sites (sts)
Sequenced taged sites (sts)Sequenced taged sites (sts)
Sequenced taged sites (sts)DHANRAJ GIRIMAL
 
In vitro data and in silico models for predictive toxicology
In vitro data and in silico models for predictive toxicologyIn vitro data and in silico models for predictive toxicology
In vitro data and in silico models for predictive toxicologyEFSA EU
 
Computer-aided prediction of xenobiotics toxicity
Computer-aided prediction of xenobiotics toxicityComputer-aided prediction of xenobiotics toxicity
Computer-aided prediction of xenobiotics toxicityMobiliuz
 
OECD and genotoxicity guidelines
OECD and genotoxicity guidelinesOECD and genotoxicity guidelines
OECD and genotoxicity guidelinesSandhya Talla
 
Alternatives to animal experiments
Alternatives to animal experimentsAlternatives to animal experiments
Alternatives to animal experimentsDr. Mohit Kulmi
 
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010TigerTox
 
Pharmacogenetics devang
Pharmacogenetics devangPharmacogenetics devang
Pharmacogenetics devangDevang Parikh
 
Tier 1, 2 and 3 Capital based on the Basel II accord
Tier 1, 2 and 3 Capital based on the Basel II accordTier 1, 2 and 3 Capital based on the Basel II accord
Tier 1, 2 and 3 Capital based on the Basel II accordNahid Anjum
 
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
 
genome mapping
genome mappinggenome mapping
genome mappingSuresh San
 
Recombinant DNA technology
Recombinant DNA technology Recombinant DNA technology
Recombinant DNA technology Saranya Sankar
 

Andere mochten auch (20)

Toxicity
ToxicityToxicity
Toxicity
 
Sequenced taged sites (sts)
Sequenced taged sites (sts)Sequenced taged sites (sts)
Sequenced taged sites (sts)
 
In vitro data and in silico models for predictive toxicology
In vitro data and in silico models for predictive toxicologyIn vitro data and in silico models for predictive toxicology
In vitro data and in silico models for predictive toxicology
 
Computer-aided prediction of xenobiotics toxicity
Computer-aided prediction of xenobiotics toxicityComputer-aided prediction of xenobiotics toxicity
Computer-aided prediction of xenobiotics toxicity
 
OECD and genotoxicity guidelines
OECD and genotoxicity guidelinesOECD and genotoxicity guidelines
OECD and genotoxicity guidelines
 
Alternatives to animal experiments
Alternatives to animal experimentsAlternatives to animal experiments
Alternatives to animal experiments
 
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010
 
Pharmacogenetics devang
Pharmacogenetics devangPharmacogenetics devang
Pharmacogenetics devang
 
In vitro-in-vivo correlation
In vitro-in-vivo correlationIn vitro-in-vivo correlation
In vitro-in-vivo correlation
 
Tier 1, 2 and 3 Capital based on the Basel II accord
Tier 1, 2 and 3 Capital based on the Basel II accordTier 1, 2 and 3 Capital based on the Basel II accord
Tier 1, 2 and 3 Capital based on the Basel II accord
 
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)
 
cell injury
cell injurycell injury
cell injury
 
Pharmacogenetics
PharmacogeneticsPharmacogenetics
Pharmacogenetics
 
genome mapping
genome mappinggenome mapping
genome mapping
 
Recombinant DNA technology
Recombinant DNA technology Recombinant DNA technology
Recombinant DNA technology
 
Immunomodulators(VK)
Immunomodulators(VK)Immunomodulators(VK)
Immunomodulators(VK)
 
Genome Mapping
Genome MappingGenome Mapping
Genome Mapping
 
Pharmacogenomics
PharmacogenomicsPharmacogenomics
Pharmacogenomics
 
TRANSPOSABLE ELEMENTS
TRANSPOSABLE ELEMENTSTRANSPOSABLE ELEMENTS
TRANSPOSABLE ELEMENTS
 
Recombinant dna technology
Recombinant dna technologyRecombinant dna technology
Recombinant dna technology
 

Ähnlich wie Session 2 part 3

chronic toxicity studies
chronic toxicity studieschronic toxicity studies
chronic toxicity studieskaran chainani
 
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDYGENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDYRahul Kadam
 
Toxicological Approach to Drug Discovery
Toxicological Approach to Drug DiscoveryToxicological Approach to Drug Discovery
Toxicological Approach to Drug DiscoverySuhas Reddy C
 
Toxicokinetic evaluation in preclinical studies.pptx
Toxicokinetic evaluation in preclinical studies.pptxToxicokinetic evaluation in preclinical studies.pptx
Toxicokinetic evaluation in preclinical studies.pptxARSHIKHANAM4
 
Oecd for chronic toxicity
Oecd for chronic toxicityOecd for chronic toxicity
Oecd for chronic toxicitypavanreddy292
 
safety-and-toxicology-lecture-notes-18.pdf
safety-and-toxicology-lecture-notes-18.pdfsafety-and-toxicology-lecture-notes-18.pdf
safety-and-toxicology-lecture-notes-18.pdfGulyChwas
 
Pre clinical studies
Pre clinical studiesPre clinical studies
Pre clinical studiesKirsha K S
 
Chronic Toxicity Study (OECD TG-452).pptx
Chronic Toxicity Study (OECD TG-452).pptxChronic Toxicity Study (OECD TG-452).pptx
Chronic Toxicity Study (OECD TG-452).pptxSIRAJUDDIN MOLLA
 
various approaches to drug discovery
various approaches to drug discoveryvarious approaches to drug discovery
various approaches to drug discoveryaiswarya thomas
 
Preclinical & clinical sk
Preclinical & clinical skPreclinical & clinical sk
Preclinical & clinical skSumit Pal
 
Experimental Techniques For Evaluation Of New Drugs.ppt
Experimental Techniques For Evaluation Of New Drugs.pptExperimental Techniques For Evaluation Of New Drugs.ppt
Experimental Techniques For Evaluation Of New Drugs.pptKarabiAdak
 
animal toxicity studies
animal toxicity studiesanimal toxicity studies
animal toxicity studiesVishnu Vardhan
 
Phase clinicaltrial
Phase clinicaltrialPhase clinicaltrial
Phase clinicaltriallillibabu
 
Safety guidelines- S3A and S3B
Safety guidelines- S3A and S3BSafety guidelines- S3A and S3B
Safety guidelines- S3A and S3Banshagrawal2121
 
Assignment on Toxicokinetics
Assignment on ToxicokineticsAssignment on Toxicokinetics
Assignment on ToxicokineticsDeepak Kumar
 

Ähnlich wie Session 2 part 3 (20)

chronic toxicity studies
chronic toxicity studieschronic toxicity studies
chronic toxicity studies
 
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDYGENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
GENERAL GUIDELINES FOR TOXICOPATHOLOGY STUDY
 
Toxicological Approach to Drug Discovery
Toxicological Approach to Drug DiscoveryToxicological Approach to Drug Discovery
Toxicological Approach to Drug Discovery
 
Toxicity studies
Toxicity studiesToxicity studies
Toxicity studies
 
Toxicokinetic evaluation in preclinical studies.pptx
Toxicokinetic evaluation in preclinical studies.pptxToxicokinetic evaluation in preclinical studies.pptx
Toxicokinetic evaluation in preclinical studies.pptx
 
Oecd for chronic toxicity
Oecd for chronic toxicityOecd for chronic toxicity
Oecd for chronic toxicity
 
safety-and-toxicology-lecture-notes-18.pdf
safety-and-toxicology-lecture-notes-18.pdfsafety-and-toxicology-lecture-notes-18.pdf
safety-and-toxicology-lecture-notes-18.pdf
 
Phase 1 protocol
Phase 1 protocolPhase 1 protocol
Phase 1 protocol
 
Pre clinical studies
Pre clinical studiesPre clinical studies
Pre clinical studies
 
Chronic Toxicity Study (OECD TG-452).pptx
Chronic Toxicity Study (OECD TG-452).pptxChronic Toxicity Study (OECD TG-452).pptx
Chronic Toxicity Study (OECD TG-452).pptx
 
Csk toxi
Csk toxiCsk toxi
Csk toxi
 
various approaches to drug discovery
various approaches to drug discoveryvarious approaches to drug discovery
various approaches to drug discovery
 
Preclinical & clinical sk
Preclinical & clinical skPreclinical & clinical sk
Preclinical & clinical sk
 
Experimental Techniques For Evaluation Of New Drugs.ppt
Experimental Techniques For Evaluation Of New Drugs.pptExperimental Techniques For Evaluation Of New Drugs.ppt
Experimental Techniques For Evaluation Of New Drugs.ppt
 
animal toxicity studies
animal toxicity studiesanimal toxicity studies
animal toxicity studies
 
Phase clinicaltrial
Phase clinicaltrialPhase clinicaltrial
Phase clinicaltrial
 
Toxi chap 3.ppt
Toxi chap 3.pptToxi chap 3.ppt
Toxi chap 3.ppt
 
Safety guidelines- S3A and S3B
Safety guidelines- S3A and S3BSafety guidelines- S3A and S3B
Safety guidelines- S3A and S3B
 
Assignment on Toxicokinetics
Assignment on ToxicokineticsAssignment on Toxicokinetics
Assignment on Toxicokinetics
 
Toxicology Screening Models.pptx
Toxicology Screening Models.pptxToxicology Screening Models.pptx
Toxicology Screening Models.pptx
 

Mehr von plmiami

Am 8.00 workowski
Am 8.00 workowskiAm 8.00 workowski
Am 8.00 workowskiplmiami
 
Am 8.45 policar vulvovag
Am 8.45 policar vulvovagAm 8.45 policar vulvovag
Am 8.45 policar vulvovagplmiami
 
Noon friedman
Noon friedmanNoon friedman
Noon friedmanplmiami
 
Am 11.20 oxentenko
Am 11.20 oxentenkoAm 11.20 oxentenko
Am 11.20 oxentenkoplmiami
 
Am 10.40 gardner
Am 10.40 gardnerAm 10.40 gardner
Am 10.40 gardnerplmiami
 
Am 9.15 awards
Am 9.15 awardsAm 9.15 awards
Am 9.15 awardsplmiami
 
Am 8.50 salganicoff
Am 8.50 salganicoffAm 8.50 salganicoff
Am 8.50 salganicoffplmiami
 
Am 8.40 diaz
Am 8.40 diazAm 8.40 diaz
Am 8.40 diazplmiami
 
Am 8.30 lee
Am 8.30 leeAm 8.30 lee
Am 8.30 leeplmiami
 
Final slide deck for dr iglesia
Final slide deck for dr iglesiaFinal slide deck for dr iglesia
Final slide deck for dr iglesiaplmiami
 
Pm 4.45 mcintyre-seltman
Pm 4.45 mcintyre-seltmanPm 4.45 mcintyre-seltman
Pm 4.45 mcintyre-seltmanplmiami
 
Pm 4.00 wisner
Pm 4.00 wisnerPm 4.00 wisner
Pm 4.00 wisnerplmiami
 
Pm 2.45 kushner
Pm 2.45 kushnerPm 2.45 kushner
Pm 2.45 kushnerplmiami
 
Pm 1.50 trudy bush
Pm 1.50 trudy bushPm 1.50 trudy bush
Pm 1.50 trudy bushplmiami
 
Evidence based management of cardiovascular disease in women
Evidence based management of cardiovascular disease in women Evidence based management of cardiovascular disease in women
Evidence based management of cardiovascular disease in women plmiami
 
Am 11.30 grunfeld
Am 11.30 grunfeldAm 11.30 grunfeld
Am 11.30 grunfeldplmiami
 
Am 10.45 lindsay bone health
Am 10.45 lindsay bone healthAm 10.45 lindsay bone health
Am 10.45 lindsay bone healthplmiami
 
Am 9.30 robertson
Am 9.30 robertsonAm 9.30 robertson
Am 9.30 robertsonplmiami
 
Am 7.15 shulman
Am 7.15 shulmanAm 7.15 shulman
Am 7.15 shulmanplmiami
 
Pm 4.50 hochberg
Pm 4.50 hochbergPm 4.50 hochberg
Pm 4.50 hochbergplmiami
 

Mehr von plmiami (20)

Am 8.00 workowski
Am 8.00 workowskiAm 8.00 workowski
Am 8.00 workowski
 
Am 8.45 policar vulvovag
Am 8.45 policar vulvovagAm 8.45 policar vulvovag
Am 8.45 policar vulvovag
 
Noon friedman
Noon friedmanNoon friedman
Noon friedman
 
Am 11.20 oxentenko
Am 11.20 oxentenkoAm 11.20 oxentenko
Am 11.20 oxentenko
 
Am 10.40 gardner
Am 10.40 gardnerAm 10.40 gardner
Am 10.40 gardner
 
Am 9.15 awards
Am 9.15 awardsAm 9.15 awards
Am 9.15 awards
 
Am 8.50 salganicoff
Am 8.50 salganicoffAm 8.50 salganicoff
Am 8.50 salganicoff
 
Am 8.40 diaz
Am 8.40 diazAm 8.40 diaz
Am 8.40 diaz
 
Am 8.30 lee
Am 8.30 leeAm 8.30 lee
Am 8.30 lee
 
Final slide deck for dr iglesia
Final slide deck for dr iglesiaFinal slide deck for dr iglesia
Final slide deck for dr iglesia
 
Pm 4.45 mcintyre-seltman
Pm 4.45 mcintyre-seltmanPm 4.45 mcintyre-seltman
Pm 4.45 mcintyre-seltman
 
Pm 4.00 wisner
Pm 4.00 wisnerPm 4.00 wisner
Pm 4.00 wisner
 
Pm 2.45 kushner
Pm 2.45 kushnerPm 2.45 kushner
Pm 2.45 kushner
 
Pm 1.50 trudy bush
Pm 1.50 trudy bushPm 1.50 trudy bush
Pm 1.50 trudy bush
 
Evidence based management of cardiovascular disease in women
Evidence based management of cardiovascular disease in women Evidence based management of cardiovascular disease in women
Evidence based management of cardiovascular disease in women
 
Am 11.30 grunfeld
Am 11.30 grunfeldAm 11.30 grunfeld
Am 11.30 grunfeld
 
Am 10.45 lindsay bone health
Am 10.45 lindsay bone healthAm 10.45 lindsay bone health
Am 10.45 lindsay bone health
 
Am 9.30 robertson
Am 9.30 robertsonAm 9.30 robertson
Am 9.30 robertson
 
Am 7.15 shulman
Am 7.15 shulmanAm 7.15 shulman
Am 7.15 shulman
 
Pm 4.50 hochberg
Pm 4.50 hochbergPm 4.50 hochberg
Pm 4.50 hochberg
 

Kürzlich hochgeladen

BeMetals Investor Presentation_May 3, 2024.pdf
BeMetals Investor Presentation_May 3, 2024.pdfBeMetals Investor Presentation_May 3, 2024.pdf
BeMetals Investor Presentation_May 3, 2024.pdfDerekIwanaka1
 
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGParadip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGpr788182
 
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All TimeCall 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Timegargpaaro
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPanhandleOilandGas
 
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfArti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfwill854175
 
Falcon Invoice Discounting: The best investment platform in india for investors
Falcon Invoice Discounting: The best investment platform in india for investorsFalcon Invoice Discounting: The best investment platform in india for investors
Falcon Invoice Discounting: The best investment platform in india for investorsFalcon Invoice Discounting
 
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Oman
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in OmanMifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Oman
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Omaninstagramfab782445
 
Cracking the 'Career Pathing' Slideshare
Cracking the 'Career Pathing' SlideshareCracking the 'Career Pathing' Slideshare
Cracking the 'Career Pathing' SlideshareWorkforce Group
 
Buy Verified TransferWise Accounts From Seosmmearth
Buy Verified TransferWise Accounts From SeosmmearthBuy Verified TransferWise Accounts From Seosmmearth
Buy Verified TransferWise Accounts From SeosmmearthBuy Verified Binance Account
 
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan Cytotec
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan CytotecJual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan Cytotec
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan CytotecZurliaSoop
 
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai KuwaitThe Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwaitdaisycvs
 
Pre Engineered Building Manufacturers Hyderabad.pptx
Pre Engineered Building Manufacturers Hyderabad.pptxPre Engineered Building Manufacturers Hyderabad.pptx
Pre Engineered Building Manufacturers Hyderabad.pptxRoofing Contractor
 
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165meghakumariji156
 
Uneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration PresentationUneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration Presentationuneakwhite
 
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannaBusinessPlans
 
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...daisycvs
 
Mckinsey foundation level Handbook for Viewing
Mckinsey foundation level Handbook for ViewingMckinsey foundation level Handbook for Viewing
Mckinsey foundation level Handbook for ViewingNauman Safdar
 
Rice Manufacturers in India | Shree Krishna Exports
Rice Manufacturers in India | Shree Krishna ExportsRice Manufacturers in India | Shree Krishna Exports
Rice Manufacturers in India | Shree Krishna ExportsShree Krishna Exports
 
Power point presentation on enterprise performance management
Power point presentation on enterprise performance managementPower point presentation on enterprise performance management
Power point presentation on enterprise performance managementVaishnaviGunji
 

Kürzlich hochgeladen (20)

BeMetals Investor Presentation_May 3, 2024.pdf
BeMetals Investor Presentation_May 3, 2024.pdfBeMetals Investor Presentation_May 3, 2024.pdf
BeMetals Investor Presentation_May 3, 2024.pdf
 
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDINGParadip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
Paradip CALL GIRL❤7091819311❤CALL GIRLS IN ESCORT SERVICE WE ARE PROVIDING
 
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All TimeCall 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
Call 7737669865 Vadodara Call Girls Service at your Door Step Available All Time
 
PHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation FinalPHX May 2024 Corporate Presentation Final
PHX May 2024 Corporate Presentation Final
 
Arti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdfArti Languages Pre Seed Teaser Deck 2024.pdf
Arti Languages Pre Seed Teaser Deck 2024.pdf
 
!~+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUD...
!~+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUD...!~+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUD...
!~+971581248768>> SAFE AND ORIGINAL ABORTION PILLS FOR SALE IN DUBAI AND ABUD...
 
Falcon Invoice Discounting: The best investment platform in india for investors
Falcon Invoice Discounting: The best investment platform in india for investorsFalcon Invoice Discounting: The best investment platform in india for investors
Falcon Invoice Discounting: The best investment platform in india for investors
 
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Oman
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in OmanMifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Oman
Mifepristone Available in Muscat +918761049707^^ €€ Buy Abortion Pills in Oman
 
Cracking the 'Career Pathing' Slideshare
Cracking the 'Career Pathing' SlideshareCracking the 'Career Pathing' Slideshare
Cracking the 'Career Pathing' Slideshare
 
Buy Verified TransferWise Accounts From Seosmmearth
Buy Verified TransferWise Accounts From SeosmmearthBuy Verified TransferWise Accounts From Seosmmearth
Buy Verified TransferWise Accounts From Seosmmearth
 
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan Cytotec
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan CytotecJual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan Cytotec
Jual Obat Aborsi ( Asli No.1 ) 085657271886 Obat Penggugur Kandungan Cytotec
 
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai KuwaitThe Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
The Abortion pills for sale in Qatar@Doha [+27737758557] []Deira Dubai Kuwait
 
Pre Engineered Building Manufacturers Hyderabad.pptx
Pre Engineered Building Manufacturers Hyderabad.pptxPre Engineered Building Manufacturers Hyderabad.pptx
Pre Engineered Building Manufacturers Hyderabad.pptx
 
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165
Lucknow Housewife Escorts by Sexy Bhabhi Service 8250092165
 
Uneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration PresentationUneak White's Personal Brand Exploration Presentation
Uneak White's Personal Brand Exploration Presentation
 
Cannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 UpdatedCannabis Legalization World Map: 2024 Updated
Cannabis Legalization World Map: 2024 Updated
 
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...
Quick Doctor In Kuwait +2773`7758`557 Kuwait Doha Qatar Dubai Abu Dhabi Sharj...
 
Mckinsey foundation level Handbook for Viewing
Mckinsey foundation level Handbook for ViewingMckinsey foundation level Handbook for Viewing
Mckinsey foundation level Handbook for Viewing
 
Rice Manufacturers in India | Shree Krishna Exports
Rice Manufacturers in India | Shree Krishna ExportsRice Manufacturers in India | Shree Krishna Exports
Rice Manufacturers in India | Shree Krishna Exports
 
Power point presentation on enterprise performance management
Power point presentation on enterprise performance managementPower point presentation on enterprise performance management
Power point presentation on enterprise performance management
 

Session 2 part 3

  • 1.
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17. Complete Toxicology Profile Preliminary Evaluation Genetic Toxicology Battery Acute Toxicology Subchronic Toxicology (14-day to 90-days) Chronic Toxicology (6-month to 12-month) Oncogenic Studies (2-year) Genetic Toxicology Kinetics Acute and Multidose Tox in vitro Tox Definitive toxicokinetics Reproductive and Developmental Tox (timing affected by inclusion of WCBP) Environmental Assessment Toxicology of major human metabolites Toxicology of degradation products Safety Pharmacology Dorato, M. A., Vodicnik, M. J. The Toxicologic Assessment of Pharmaceutical and Biotechnology Products. in Principles and Methods of Toxicology . Raven Press, 1994
  • 18.