Medscape

Bioavailability and Bioequivalence of Two Enteric-Coated Formulations of Omeprazole in Fasting and Fed Conditions

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 ...
Business Insider

Acer Therapeutics Announces Full Enrollment of Part A in ACER-001 Pivotal Bioavailability and Bioequivalence Trial for Urea Cycle Disorders

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 ...
newscase

Bionxt Solutions Advances Key Drug Delivery Program

Bionxt Solutions is accelerating development of its flagship project, moving a Cladribin-based dissolvable film toward human ...
Nasdaq

Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X

NEW YORK and MELBOURNE, Australia, July 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing ...
JD Supra

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

Maven Semantic: Database of Bioavailability / Bioequivalence Professionals

DUBLIN--(BUSINESS WIRE)-- Maven Semantic (http://www.mavensemantic.com) announces updates to their Bioavailability / Bioequivalence database. The new database is now ...
JD Supra

Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...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

Final Results of Bioavailability Study of Phebra's Oral Arsenic Capsule for Acute Promyelocytic Leukaemia (APL) Confirm Bioequivalence of Oral and IV Formulations

SYDNEY, May 13, 2021 /PRNewswire/ -- Australian pharmaceutical group Phebra ('Company') congratulates the Australasian Leukaemia and Lymphoma Group (ALLG) on the release of their abstract EP433 at the ...
ascopubs.org

The absolute oral bioavailability (BA) of 150-mg and bioequivalence (BE) of six 25- and one 150-mg erlotinib (E) tablets, a small molecule inhibitor of the epidermal growth ...

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 ...
Nasdaq

Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company’s Proprietary Drug for Treatment of Obstructive Sleep Apnoea ...

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 ...
Nature

Levothyroxine dosage and the limitations of current bioequivalence standards

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 ...
Medscape

Bioavailability and Bioequivalence of Two Enteric-Coated Formulations of Omeprazole in Fasting and Fed Conditions

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 ...