Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition
Features
- Presents a complete guide to regulatory requirements, including US, international, and special overseas cases
- Offers a clear description of what is needed and why for supporting drug development
- Covers the core and supplemental batteries of test procedures and how to do them
- Describes the tricks of the trade for study performance and interpretation
- Thoroughly overviews available facilities and contract organizations for performing studies
Summary
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.
Table of Contents
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
Author Bio(s)
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.
