The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010.
Since the United States Pharmacopeia (USP) and National Formulary (NF) General Notices combined, it could be interpreted that API requirements apply to excipients. In USP–NF General Notices, an API ...
FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics. In an important step for modernizing drug formulation and ...
Dublin, Aug. 12, 2020 (GLOBE NEWSWIRE) -- The "Analysis of the Global Oral Solid Dosage Excipients Market, Forecast to 2025" report has been added to ResearchAndMarkets.com's offering. Excipients have ...
The purpose of formulation development is to ensure that the drug is safe, effective, stable, and convenient to use. If the dosage form is improperly selected and if the prescription and process ...
When it comes to drugs, most of the attention goes to the active pharmaceutical ingredient. But typically the vast majority of what’s in a tablet, capsule, or liquid isn’t the active ingredient. A ...
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