Drug Discovery and Evaluation has safety aspects that were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound.
These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity.
Contents
Section 1: Safety Pharmacolgoy
- Status of Safety Pharmacology and Present Guidelines
- Central Nervous System (CNS) Safety Pharmacology Studies
- Methods in Cardiovascular Safety Pharmacology
- Safety Pharmacology of Drugs for the Urinary Tract
- Respiratory Function Assays in Safety Pharmacology
- Metabolism Pharmacology
- Peripheral Nervous System
- Safety of Intravenous and Inhalation Anesthetics
- Side Effects of Central Analgesic Drugs
- Safety Pharmacology of Antiinflammatory Drugs
...and chapters K-P
Section 2: Safety Pharmacokinetics
- Physicochemical Properties
- In-Silico ADME Modeling
- Absorption—in vitro Tests—Cell Based
- Absorbtion—in vitro Tests—Non-Cell Based
- Distribution—in vitro Tests—Protein Binding
- Perfused Organs
- Metabolism Studies in vitro and in vivo
- Distribution—Across Barriers
- Drug—Drug Interaction—Enzyme Induction
- Drug—Drug Interaction—Enzyme Inhibition
...and chapters K-R
Section 3:Safety Toxicology
- Internationl Guidelines for the Development of Pharmaceutical Compounds
- General Toxitity
- In Silico Methods
- Alternative Methods for Carcinogenity Testing
- Genotoxicity
- Reproduction Toxicology
- Toxicogenomics and Toxicoproteomics
- Application of Toxicoproteomics in Profiling Drug Effects
Index
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