Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition, 2nd Edition (Hardback) book cover

Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition, 2nd Edition

By Shayne C. Gad

CRC Press

213 pages | 11 B/W Illus.

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pub: 2012-04-26
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Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions.

Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.

The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

Table of Contents

Safety Pharmacology: Background, History, Issues, and Concerns

General versus safety pharmacology


Reasons for poor predictive performance

Why tiers

Study designs and principles


Integral versus separate

Regulatory Requirements: ICH, FDA, EMA, and Japan

Regulatory requirements

Principles of Screening and Study Design


Characteristics of screens

Uses of screens

Types of screens

Criterion: Development and use

Analysis of screening data

Study design


Cardiovascular System




Central Nervous System

Core battery CNS procedures



Sleep induction and interaction with hypnotics

Higher cognitive function

Isolated tissue assays

CNS function: Electroencephalography

Neurochemical and biochemical assays

Respiratory System


Design of respiratory function safety studies

Study design considerations

Renal Function

Major functions of the kidney

Acute renal failure

Functional reserve of the kidney


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


The Immune System

Introduction to the immune system and adverse modulation activities of drugs

Overview of the immune system

Immunotoxic effects

About the Author

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.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
MEDICAL / Toxicology