| Description |
1 online resource (189 pages) : illustrations |
| 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 |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drugs -- Toxicology.
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Drugs -- Safety measures
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Drug Evaluation, Preclinical
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Drug Approval
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Toxicity Tests
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MEDICAL -- Pharmacology.
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Drugs -- Safety measures
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Drugs -- Toxicology
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| Form |
Electronic book
|
| LC no. |
2003051468 |
| ISBN |
0203499182 |
|
9780203499184 |
|
