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Pharmaceutical formulation. Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.
Formulary (pharmacy) A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. [1] Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication (a resource closer to what would be referred to ...
Martindale: The Complete Drug Reference is a reference book published by Pharmaceutical Press listing some 6,000 drugs and medicines used throughout the world, including details of over 125,000 proprietary preparations. It also includes almost 700 disease treatment reviews. It was first published in 1883 under the title Martindale: The Extra ...
Physicians' Desk Reference. The Physicians' Desk Reference (PDR), renamed Prescriber's Digital Reference after its physical publication was discontinued, is a compilation of manufacturers' prescribing information (package insert) on prescription drugs, updated regularly and published by ConnectiveRx. [citation needed]
Generic Product Identifier. The Generic Product Identifier (GPI) is a 14-character hierarchical classification system created by Wolters Kluwer's Medi-Span that identifies drugs from their primary therapeutic use down to the unique interchangeable product regardless of manufacturer or package size. The code consists of seven subsets, each ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components (excipients), configured in a particular way (such as a capsule shell) and apportioned into a specific dose. For example, two products may both be amoxicillin, but one ...
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan ...