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Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [1] [2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding ...
Pharmacology is the science of drugs and medications, including a substance's origin, composition, pharmacokinetics, pharmacodynamics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function.
Drug design. Drug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. [1] The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn ...
Dupage Medical Group Internal Medicine Elmhurst. 533 W North Ave Ste 101 Elmhurst, IL 60126. (630) 279-8771. OVERVIEW.
Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Practice Systems and Programs (GPSP)
Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs. It utilizes the fields of chemical engineering, biomedical engineering, pharmaceutical sciences, and ...
Dietary supplement. A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid. [2] A supplement can provide nutrients either extracted from food sources, or that are synthetic (in order to increase the quantity of their consumption).
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