The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study. The ...
DUBLIN--(BUSINESS WIRE)-- Maven Semantic (http://www.mavensemantic.com) announces updates to their Bioavailability / Bioequivalence database. The new database is now ...
A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010. A new guideline 1 for conducting bioequivalence studies was ...
The BA/BE clinical trial was designed to compare the bioavailability of dronabinol and acetazolamide in IHL-42X as a fixed dose combination drug to the FDA reference listed drugs Marinol and Taro ...
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...
Treatment outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) and cardiovascular disorders or diabetes: The Prostate Cancer Registry. PK parameters of abiraterone BA with SS ...
A multicenter phase II trial of gefitinib 500 mg/day in 193 patients with advanced epidermal growth factor receptor-positive solid tumors who had failed previous chemotherapy: Interim data ...
WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) today announced its bioanalytical operation has been certified by Brazil's Agencia Nacional de Vigilancia Sanitaria (ANVISA), validating ...
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