Safety pharmacology in pharmaceutical development and approval. (©2004)

• Record Type: Book
• Further Information: Note: Shayne C. Gad.
• Other Names: Gad, Shayne C, 1948-
• 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
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2004
• Copyright Date: 2004
• Extent: 1 online resource (189 pages), illustrations
• Subjects: 615/.704; Drugs -- Toxicology; Drugs -- Safety measures; Drug Evaluation, Preclinical; Drug Approval; Toxicity Tests; MEDICAL -- Pharmacology; Drugs -- Safety measures; Drugs -- Toxicology; Electronic books
• Languages: English
• ISBNs: 0203499182; 9780203499184
• Related ISBNs: 0849313805; 9780849313806
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.