Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition

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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

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
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.