Objective: To investigate the relative bioavailability and bioequivalence, in fasting and fed conditions, of repeated doses of two omeprazole enteric-coated formulations in healthy volunteers. Proton ...

NEWTON, Mass., Oct. 28, 2019 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

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 ...

You have full access to this article via your institution. These results have led the Endocrine Society, the American Association of Clinical Endocrinologists, and the American Thyroid Association ...

PRINCETON, N.J.--(BUSINESS WIRE)--Certara ® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp ® ...

Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability and bioequivalence studies.

TABLET: Relative bioavailability and bioequivalence study of niraparib tablets and capsules in patients with advanced solid tumors.

Indian pharma industry is intensifying its focus on quality systems, regulatory alignment, and scientific rigor as the Central Drugs Standard Control Organisation (CDSCO) continues to strengthen ...

Inhibition of gastric acid secretion by omeprazole increases with continuous drug administration and reaches a plateau after about 4 days of therapy. [19] In the present study, the relative ...