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Important Considerations for the Clinical
Resolving Ethical and Moral Problems
Coping with Regulations and Legal Aspects
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absorption active adverse reaction Agents amygdalin analysis animal approved benefit bioavailability bioavailability studies bioequivalence blind blood levels cholesterol Clinical Evaluation clinical research clinical studies clinical trials clofibrate codes completely randomized design conduct considered CRFs crossover determine discussed disease documentation dosage forms dose double blind Drug Administration drug application drug development drug products Drugs GPO effects established ethical example experiment experimental Food and Drug Guidelines informed consent initial Institutional Review Board investigator's involved issues laboratory Laetrile marketed ment metabolism monitoring number of patients objective optimal participate patient population percent Pfizer pharmaceutical pharmacokinetic pharmacologic Phase IV studies phenytoin physician placebo potential practice problems procedures protocol question randomized records regulations regulatory renal report forms response risk safety and efficacy sample scientific specific sponsor statistical study design therapeutic therapy tion toxicity treatment usually vivo