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Safety Pharmacology in Pharmaceutical Development and Approval

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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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Editorial Reviews

Doody's Review Service
Reviewer: Richard H. Alper, PhD (Pfizer Inc.)
Description: This book provides an introduction to the newly developing discipline of safety pharmacology. After an initial overview of the history and regulatory requirements for safety pharmacology, the author provides descriptions of in vivo and in vitro pre-clinical tests used to assess the effects of novel chemical entities on the function of most of the major organ systems.
Purpose: This book was written to answer questions about safety pharmacology and to add clarity to existing requirements. The primary objective is very timely because the discipline is not well recognized even though it is becoming increasingly critical in drug discovery and development. To present a review of the current regulatory environment and the practices used in the discipline is noteworthy. The book falls short in its second goal to add clarity to the existing requirements. As written, it is sometimes difficult for the reader to get a good understanding of the ICH guidelines as compared to the author's interpretation and extension of the guidelines.
Audience: The author does not state the intended audience for this book. The most appropriate audience is likely to be graduate students, academic pharmacologists and toxicologists, and people in related disciplines in academia and industry who are not directly involved in safety pharmacology. This book will provide them with knowledge of the field.
Features: In addition to addressing the regulatory issues, the book covers methodologies used or useful in the functional assessments of organ systems. It might have been clearer had the author included major divisions of the core battery (defined as CNS, cardiovascular and respiratory in the ICH guidelines) and supplemental studies (respiratory, renal, GI and other).
Assessment: The book is nicely written and provides some useful insight into the current state of the field. However, the author intermingles the concepts of safety pharmacology with overall safety assessments in drug development. Safety pharmacology studies are to support first in human studies (FIH) that are most commonly single dose studies in healthy human subjects. Much of the book discusses multidose, pre-clinical protocols using animal models of specific disease states. This might leave the reader with a misconception of what is required of the safety pharmacologist.

2 Stars from Doody
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Product Details

  • ISBN-13: 9780849313806
  • Publisher: CRC Press
  • Publication date: 6/28/2003
  • 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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