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 ...

Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

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 ...

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 ...

MELBOURNE, Australia, July 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique ...

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.

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 ...