Drug Safety Evaluation, Third Edition.

"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Gad, Shayne Cox
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Somerset : John Wiley & Sons, Incorporated, 2016.
Edición:3rd ed.
Colección:Pharmaceutical Development Ser.
Temas:
Drugs > Toxicology.
Drugs > Testing.
MĐedicaments > Toxicologie.
MĐedicaments > Essais cliniques.
Drugs > Testing
Drugs > Toxicology
Acceso en línea:Texto completo

MARC

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035 |a (OCoLC)965778378 
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049 |a UAMI 
100 1 |a Gad, Shayne Cox. 
245 1 0 |a Drug Safety Evaluation, Third Edition. 
250 |a 3rd ed. 
260 |a Somerset :  |b John Wiley & Sons, Incorporated,  |c 2016. 
300 |a 1 online resource (917 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Pharmaceutical Development Ser. 
588 0 |a Print version record. 
505 0 |a TITLE PAGE ; COPYRIGHT PAGE ; CONTENTS ; PREFACE ; ABOUTH THE AUTHOR ; CHAPTER 1 THE DRUG DEVELOPMENT PROCESS AND THE GLOBAL PHARMACEUTICAL MARKETPLACE; 1.1 INTRODUCTION; 1.2 THE MARKETPLACE; 1.3 HISTORY OFÈMODERN THERAPEUTICS; 1.4 THE DRUG DEVELOPMENT PROCESS; 1.5 STRATEGIES FORÈDEVELOPMENT: LARGE VERSUS SMALL COMPANY OR THEÈSHORT VERSUS LONG GAME; 1.5.1 Do Only What YouÈMust; 1.5.2 Minimize theÈRisk ofÈSubsequent Failure; 1.6 SAFETY ASSESSMENT ANDÈTHEËVOLUTION OFÈDRUG SAFETY; 1.7 THE THREE STAGES OFÈDRUG SAFETY EVALUATION INÈTHEÈGENERAL CASE; REFERENCES. 
505 8 |a CHAPTER 2 REGULATION OF HUMAN PHARMACEUTICAL SAFETY: ROUTES TO HUMAN USE AND MARKET 2.1 INTRODUCTION ; 2.2 BRIEF HISTORY OFÜS PHARMACEUTICAL LAW; 2.2.1 1906: Pure Food andÈDrug Act; 2.2.2 1938: Food, Drug, andÈCosmetic Act; 2.2.3 1962: Major Amendment; 2.2.4 1992, 1997, 2002, 2007, andÈ2012: PDUFAändÈFDAMA; 2.3 FDAMA SUMMARY: CONSEQUENCES ANDÖTHER REGULATIONS; 2.4 OVERVIEW OFÜS REGULATIONS; 2.4.1 Regulations: General Considerations; 2.4.2 Regulations: Human Pharmaceuticals; 2.4.3 Regulations: Environmental Impact; 2.4.4 Regulations: Antibiotics; 2.4.5 Regulations: Biologics. 
505 8 |a 2.4.6 Regulations versus Law2.5 ORGANIZATIONS REGULATING DRUG ANDÈDEVICE SAFETY INÈTHEÜNITED STATES; 2.6 PROCESS OFÈPHARMACEUTICAL PRODUCT DEVELOPMENT ANDÄPPROVAL; 2.7 TESTING GUIDELINES; 2.7.1 Toxicity Testing: Traditional Pharmaceuticals; 2.7.2 General or Systematic Toxicity Assessment; 2.7.3 Genetic Toxicity Assessment; 2.7.4 Safety Pharmacology; 2.7.5 Local Tissue Tolerance; 2.7.6 Toxicity Testing: Biotechnology Products; 2.8 TOXICITY/SAFETY TESTING: CELLULARÄNDÈGENE THERAPY PRODUCTS; 2.8.1 Cellular Therapies; 2.8.2 Gene Therapies; 2.8.3 Ex Vivo; 2.8.4 In Vivo. 
505 8 |a 2.8.5 Preclinical Safety Evaluation2.8.6 Basic Principles forÈPreclinical Safety Evaluation ofÈCellular andÈGene Therapies; 2.8.7 Additional Considerations forÈCellular Therapies; 2.8.8 Additional Considerations forÈGene Therapies; 2.9 TOXICITY TESTING: SPECIAL CASES; 2.9.1 Oral Contraceptives; 2.9.2 Life-Threatening Diseases (Compassionate Use) ; 2.9.3 Optical Isomers; 2.9.4 Special Populations: Pediatric andÈGeriatric Claims; 2.9.5 Orphan Drugs; 2.9.6 Botanical Drug Products; 2.9.7 Types ofÈNew Drug Applications (NDAs); 2.10 INTERNATIONAL PHARMACEUTICAL REGULATION ANDÈREGISTRATION. 
505 8 |a 2.10.1 International Conference onḦarmonization2.10.2 Other International Considerations; 2.10.3 Safety Pharmacology; 2.11 COMBINATION PRODUCTS; 2.11.1 Device Programs That CDER andÈCBRH Each Will Administer; 2.11.2 Coordination; 2.11.3 Submissions; 2.12 CONCLUSIONS; REFERENCES; FURT HER READING; CHAPTER 3 DATA MINING: SOURCES OF INFORMATION FOR CONSIDERATION IN STUDY AND PROGRAM DESIGN AND IN SAFETY EVALUATION ; 3.1 INTRODUCTION; 3.1.1 Claims; 3.1.2 Time andËconomies; 3.1.3 Prior Knowledge; 3.1.4 Miscellaneous Reference Sources; 3.1.5 Search Procedure. 
500 |a 3.1.6 Monitoring Published Literature andÖther Research inÈProgress. 
520 |a "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--  |c Provided by publisher. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Drugs  |x Toxicology. 
650 0 |a Drugs  |x Testing. 
650 6 |a MĐedicaments  |x Toxicologie. 
650 6 |a MĐedicaments  |x Essais cliniques. 
650 7 |a Drugs  |x Testing  |2 fast 
650 7 |a Drugs  |x Toxicology  |2 fast 
758 |i has work:  |a Drug Safety Evaluation, Third Edition (Text)  |1 https://id.oclc.org/worldcat/entity/E39PCYVgckFmbTGPQyb7kTGXMP  |4 https://id.oclc.org/worldcat/ontology/hasWork 
776 0 8 |i Print version:  |a Gad, Shayne Cox.  |t Drug Safety Evaluation, Third Edition.  |d Somerset : John Wiley & Sons, Incorporated, Ã2016  |z 9781119097396 
830 0 |a Pharmaceutical Development Ser. 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=4753453  |z Texto completo 
936 |a BATCHLOAD 
994 |a 92  |b IZTAP 

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