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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 minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
Antipsychotics by class Generic name Brand names Chemical class ATC code Typical antipsychotics; Acepromazine: Atravet, Acezine: phenothiazine: N05AA04
A new study (the first clinical trial of its kind) has shown that the GLP-1 agonist semaglutide — known by the brand name Ozempic — may help reduce not only alcohol cravings, but the amount of ...
“Buprenorphine became the first-line treatment,” Auriacombe said, adding that the medication has helped to change public and law enforcement perceptions about addicts. An article in the May issue of the New England Journal of Medicine called for wider U.S. use of medication-assisted therapies for addicts, commonly referred to as MATs.
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A new review reports that nine people taking semaglutide and tirzepatide — the active ingredient in GLP-1 medications — experienced vision issues, including three potentially blinding eye ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.