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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
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Journal of Pharmaceutical and Biomedical Analysis is a peer-reviewed medical journal that covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences. [1] The journal is published by Elsevier. [2]
Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposure ...
The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, [1] is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately.
The thirteenth edition authors received three-million dollars from pharmaceutical companies which was undisclosed. Unlike earlier editions which were praised for being up to date, [4] an analysis of the 13th edition found that the citations were older than those of other pharmacology textbooks. [9]
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or an existing drug into a medication to be used safely and effectively by patients. [1]
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.