Cargando…

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:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.