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  2. Pharmacopoeia - Wikipedia

    en.wikipedia.org/wiki/Pharmacopoeia

    The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

  3. United States Pharmacopeia - Wikipedia

    en.wikipedia.org/wiki/United_States_Pharmacopeia

    USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.

  4. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e ...

  5. Medical prescription - Wikipedia

    en.wikipedia.org/wiki/Medical_prescription

    The prescription symbol, ℞, as printed on the blister pack of a prescription drug. A prescription, often abbreviated ℞ or Rx, is a formal communication from physicians or other registered healthcare professionals to a pharmacist, authorizing them to dispense a specific prescription drug for a specific patient.

  6. Martindale: The Complete Drug Reference - Wikipedia

    en.wikipedia.org/wiki/Martindale:_The_complete...

    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.

  7. Drug Master File - Wikipedia

    en.wikipedia.org/wiki/Drug_Master_File

    In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.

  8. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]

  9. Pharmaceutical formulation - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_formulation

    Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patients. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from ...