Clinical Measurement in Drug EvaluationCRC Press, 1991 M09 27 - 256 pages Clinical measurement of the therapeutic and adverse effects of a drug is an important part of drug evaluation and registration. This volume presents full coverage of the principles and practice of the measurement of drug effects in humans and its role in the evaluation and development of new drugs. Clinical interpretation and relevance of data, as well as the acceptability and accuracy of methodology are emphasized together with the special problems of the cardiovascular system and the central nervous system. Contributions are from an international team of scientists and clinicians from both academia and industry. Clinical Measurement in Drug Evaluation will be useful for clinical and research scientists, research-based pharmacologists, and the pharmaceutical industry. |
Contents
Mortality in the evaluation of cardiovascular drugs | 5 |
Exercise testing in the clinical pharmacology of heart failure | 13 |
The monitoring of arterial pressure | 23 |
Dose and concentrationeffect relationships | 35 |
uses in the assessment of drug | 45 |
Psychometric screening of new drugs | 57 |
Pain models in healthy volunteers | 73 |
Analgesic clinical trials | 85 |
Cancer chemotherapy tumour markers | 127 |
Markers of drug allergy | 143 |
Gastrointestinal methodology for the evaluation of drug | 151 |
The importance of pharmacodynamic studies in phase I trials | 165 |
The use of clinical samples for the biomonitoring of genotoxic | 173 |
5 | 188 |
Special population studies | 203 |
Detection and collection of adverse drug reactions | 213 |
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Common terms and phrases
abnormalities acid active adducts adverse drug reactions agents ambulatory analgesia analgesic analogue analysis anaphylaxis arterial pressure aspirin assays assessment biomonitoring blood pressure cancer cardiac cardiotoxicity cardiovascular cells chemical chromosomal cimetidine Clin clinical trials compliance compound concentration cumulative dose cytogenetic detect dipipanone disease dosage dose finding studies dose-response drug effects duodenal ulcer efficacy Endoscopy Epirubicin exercise exposure factors felodipine Figure flecainide gastric emptying genotoxicity healing healthy volunteers heart failure human hypertension increased indicate investigator laboratory lymphocytes markers measure metabolites methods metoprolol mg/m² micronuclei monitoring mortality motility myocardial myocardial infarction nifedipine non-invasive oesophageal omeprazole pain patients performance pharmacodynamic pharmacokinetic Pharmacol pharmacology phase placebo plasma population potential pre-clinical prostaglandin protocol randomised ranitidine rating scale reactions regimen relationship response rioprostil risk samples score sensitivity specific subjects techniques therapeutic therapy toxicity treadmill treatment tumour urine validation variability vitro