Gad Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition
2. Auflage 2012
ISBN: 978-1-4398-4568-4
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 213 Seiten

This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international—especially Europe and Japan) and updated test methods, interpretation, and science.

Zielgruppe

Toxicologists, pharmacologists, investors, regulatory experts, and pharmaceutical development professionals

Autoren/Hrsg.

Gad, Shayne C.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie

Inhaltsverzeichnis

Safety Pharmacology: Background, History, Issues, and Concerns
General versus safety pharmacology
History
Reasons for poor predictive performance
Why tiers
Study designs and principles
Issues
Integral versus separate

Regulatory Requirements: ICH, FDA, EMA, and Japan
Regulatory requirements

Principles of Screening and Study Design
Introduction
Characteristics of screens
Uses of screens
Types of screens
Criterion: Development and use
Analysis of screening data
Study design
References

Cardiovascular System
Introduction
History
Summary

Central Nervous System
Core battery CNS procedures
Rat
Dog
Sleep induction and interaction with hypnotics
Higher cognitive function
Isolated tissue assays
CNS function: Electroencephalography
Neurochemical and biochemical assays

Respiratory System
Plethysmography
Design of respiratory function safety studies
Study design considerations

Renal Function
Major functions of the kidney
Acute renal failure
Functional reserve of the kidney
Clearance
Free water clearance and renal concentrating ability
Clinical chemistry measures
Animal models
Examples of species differences in drug sensitivity

The Gastrointestinal System
Drug-induced alterations of GI transit or motility
Gastrointestinal function
Assessment of intestinal transit
Determination of intestinal absorption
Gastric emptying rate and gastric pH changes: A new model
Effects of drugs on gut immune system (jejunum, ileum, colon)
Candidate drugs to evaluate for effects on gut immune system
Conclusions

The Immune System
Introduction to the immune system and adverse modulation activities of drugs
Overview of the immune system
Immunotoxic effects

Über Autor(innen)

Shayne Cox Gad is Principal at Gad Consulting Services in Cary, North Carolina. He has over 33 years experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries.