Safety Pharmacology in Pharmaceutical Development and Approval

Safety Pharmacology in Pharmaceutical Development and Approval

by Shayne C. Gad
     
 

ISBN-10: 0849313805

ISBN-13: 9780849313806

Pub. Date: 06/28/2003

Publisher: Taylor & Francis

The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Conference on

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Overview

The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Conference on Harmonization (ICH) guidelines, safety pharmacology will become a more important phase in drug development.

Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery.

Until recently, pharmacovigilance has been product-rather than utilization-oriented and often invisible in clinical medicine. It is clear that definitive safety pharmacology standards are needed to combat the increase in adverse reactions seen in the last 20 years. Giving you a head start in this emerging field, Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.

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Product Details

ISBN-13:
9780849313806
Publisher:
Taylor & Francis
Publication date:
06/28/2003
Pages:
208
Product dimensions:
6.30(w) x 9.50(h) x 0.66(d)

Table of Contents

SAFETY PHARMACOLOGY: BACKGROUND, HISTORY, ISSUES, AND CONCERNS
General vs Safety Pharmacology
History
Reasons for Poor Predictive Performance
Why Tiers?
Study Designs and Principles
Issues
Summary
References

REGULATORY REQUIREMENTS OF ICH, U.S. FDA, EMEA, AND JAPAN MHW
Regulatory Requirements
References

PRINCIPLES OF SCREENING AND STUDY DESIGN
Introduction
Characteristics of Screens
Uses of Screens
Types of Screens
Criterion: Development and Use
Analysis of Screening Data
Univariate Data
Multivariate Data
Study Design
References

CARDIOVASCULAR SYSTEM
Introduction
History
Regulatory Developments
Summary
References

CENTRAL NERVOUS SYSTEM
Core Battery CNS Procedures
References

RESPIRATORY SYSTEM
Plethysmography
Design of Respiratory Function Safety Studies
Summary
References

RENAL FUNCTION
Major Functions of the Kidney
Acute Renal Failure (ARF)
Functional Reserve of the Kidney
Clearance
Free Water Clearance and Renal Concentrating Ability
Clinical Chemistry Measures
Animal Models
References

THE GASTROINTESTINAL SYSTEM
Drug-Induced Alterations of GI Transit or Motility
GI Function
Assessment of Intestinal Transit
Determination of Intestinal Absorption
Conclusions
References

SAFETY PHARMACOLOGY OF THE IMMUNE SYSTEM
Introduction
PCA Test for Potential Antigenicity of Compound
Overview of the Immune System
Immunotoxic Effects
Immunosupression
References

INTEGRATION OF EVALUATIONS INTO OF SAFETY PHARMACOLOGY into Existing Study Designs
Rodent Acute Toxicity
Nonrodent Acute Toxicology
Repeated Dose (IND Pivotal Toxicity) Studies
Integration
References

Selected regulatory and Toxicological Acronyms
Safety Pharmacology Labs
Index

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