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Compounding for Investigational and Clinical Studies

Author(s):  Allen Loyd V Jr

Issue:  May/Jun 2022 - Volume 26, Number 3
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Abstract:  An investigational drug study is a biomedical or health-related research study in humans or animals that follows a predefined protocol. Preclinical studies involve the testing of potential drugs in the laboratory setting or in animals and typically are conducted before a clinical study. In the medical and pharmaceutical literature, hundreds of clinical and investigational studies are reported annually comparing the effects of different drugs, dosage forms, and delivery systems. These studies may compare different products, or they may compare a product with a placebo. A compounding pharmacist is often the source of the products used in these drug studies

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, investigational studies, clinical trials, Current Good Manufacturing Practices, placebo, customized dosage forms, quality control, standard operating procedures, raw materials, in-process items, packaging materials, labels, finished product testing, stability data, documentation, storage conditions, N-of-1 studies, United States Pharmacopeia Chapter <1168>, USP

Related Categories: ENVIRONMENTAL , LEGAL, SOPs, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, INFORMATION RESOURCES

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