Safety pharmacology in pharmaceutical development : approval and post marketing surveillance /: approval and post marketing surveillance. (2012)

• Record Type: Book
• Further Information: Note: Shayne C. Gad.
• Other Names: Gad, Shayne C, 1948-; Gad, Shayne C, 1948-
• 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;
• Edition: 2nd ed
• Publisher Details: Boca Raton, Fla : CRC Press/Taylor & Francis
• Publication Date: 2012
• Extent: 1 online resource (xv, 180 pages :), illustrations
• Subjects: 615.7/04; Drug development -- Safety measures; Drugs -- Toxicology; Drugs -- Safety measures; Drug Evaluation, Preclinical; Drug Approval; Product Surveillance, Postmarketing; Toxicity Tests; Electronic books
• Languages: English
• ISBNs: 9781439845684; 1439845689
• Related ISBNs: 9781439845677
• Notes: Note: Includes bibliographical references.
• 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.