DDS - LAW

• Formulation


  The name, strength, and reference monograph of all APIs and/or excipients present in the drug product
• Generic Class Name


  The identification of a drug product containing three or more APIs by its scientifically and internationally recognized name or by its official generic name as determined by FDA
• Generic Name


  The identification of a drug product by its scientifically and internationally recognized API or by its official generic name as determined by FDA
• Indication


  The FDA-approved clinical use of a drug product based on substantial, scientifically supported evidence of its safety and efficacy in the given dosage form
• Investigational Product


  A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use
• Label


  The written, printed or graphic matter on any drug product, its immediate container, tag, literature or other suitable material affixed thereto for the purpose of giving information as to the identity, components, ingredients, attributes, directions for use, specifications and such other information as may be required by law or regulation
• Labeling Materials


  Label on the immediate container, and the other printed materials that are made available with the drug product at the time of purchase and/or when the product is used, such as the outer wrapper cartons, package insert/leaflet accompanying the product, which provide the accurate and necessary detailed information for the identification and proper use of the product
• Lot Number


  Any distinctive combination of letters and/or numbers assigned to a particular lot, herein defined as a portion of a batch
• Manufacturer


  An establishment engaged in any and all operations involved in the production of health products as well as the final release of the finished product, with the end view of its storage, sale or distribution, provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies
• Marketing Authorization (MA)


  An official document issued by the competent drug regulatory authority (DRA) for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy, and quality, and containing, inter alia: the name of the product, the pharmaceutical dosage form; the quantitative formula (including excipients) per unit dose, the shelf-life and storage condition(s); and packaging characteristics, specific information on which authorization is based (e.g. "The product(s) must conform with all the details provided in the application and as modified in subsequent correspondence."); the product information approved for health professionals and the public, the sales category, the name and
• Date of Manufacture


  The date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed
• Active Moiety


  The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance
• Active Pharmaceutical Ingredient (API)


  A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound (ingredient)
• Adverse Drug Reaction (ADR)


  A response to a medicine that is noxious and unintended, and which occurs at doses normally used in man
• Batch


  A defined quantity of starting material, packaging material or product manufactured in a single or series of processes so that it can be expected to be homogeneous. (In the case of continuous manufacture, the batch must correspond to a defined fraction of production, characterized by its intended homogeneity; it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch)
• Batch Number


  A distinctive combination of numbers and/or letters which specifically identifies a batch on the labels, the batch records, and the certificates of analysis, etc.
• Biological Product


  Any product of biological origin, prepared with biological processes, derived from human blood and plasma, or manufactured by biotechnology, consisting of substances of higher molecular weight whose purity, potency, and composition cannot readily and reliably be determined by chemical or physicochemical analysis. Examples of this group include vaccines, blood products, modified animal tissues, high molecular weight hormones, allergens, and the products of genetic engineering or other newer biotechnological techniques. This definition does not include antibiotics and substances that, although of biological origin, are of low molecular weight and can be isolated as pure substances, such as purified steroids and alkaloids
• Brand Name


  The proprietary name assigned to the product by the Marketing Authorization Holder (MAH)
• Contraindication


  A statement regarding the conditions wherein the use of the drug product may cause harm to the patient
• Marketing Authorization Holder (MAH)


  The company or corporate or legal entity in the field of pharmaceuticals in whose name the MA for a drug product has been granted. This party is responsible for all aspects of the product, including quality and compliance with the conditions of the MA. The authorized holder must be subjected to legislation in the country that issued the MA, which normally means being physically located in that country. In the Philippines, the MAH may either be a manufacturer or distributor (exporter, importer or wholesaler).
• Mode of Administration


  The manner and site where the drug product is to be introduced into or applied on the body.
• Net Content


  The total amount/quantity/number of the dosage form in a certain container of a drug product expressed in metric system.
• New Chemical Entity (NCE)


  New chemical or biological API not previously authorized for marketing for any pharmaceutical use in the country in question.
• Over-the-Counter (OTC) Drugs


  Drug products that can be dispersed even without the written order of a licensed physician or dentist.
• Pack Size


  Refers to the quantity of dosage form in the final packaging (excluding the shipping carton) of a drug product bearing the required labeling information.
• Package Insert (PI)


  The document defining information that is supplied with prescription drug products by the MAH. The Pl is intended for use by healthcare professionals.
• Patient Information Leaflet (PIL)

  The document defining information that is supplied with non-prescription drug products by the MAH. The PIL is intended for use by patients and is written in layman's language.
• Pharmacologic Category


  The classification of the drug product based on its therapeutic action as specified in the product registration.
• Precautions


  The instruction and the special care required in the use of the drug product to avoid undesired effects and to ensure its safe and effective use.
• Prescription Drug Products


  Drug products that are to be dispensed only upon the written order or prescription of a duly licensed physician or dentist for the management or treatment of a condition or a diagnosed disease of man.
• Primary Label


  The label on the primary packaging material of a drug product.
• Prodrug


  A drug substance that is inactive in the intended pharmacological actions and must be converted into the pharmacologically active agent by metabolic or physico-chemical transformation.
• Product Name


  The name (i.e. generic name and brand name, if any) of the drug product as registered in FDA.
• Product Description


  Refers to the complete organoleptic description of the finished drug product.