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FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirements for ...
RAPS

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and ...
Nature

Bioequivalence Studies and Adaptive Design Methods

Bioequivalence studies are an essential component in the development and approval of generic pharmaceutical products, ensuring that they perform similarly to their reference counterparts. These ...
Seeking Alpha

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 (IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal ...
News Medical

What is bioequivalence and how is it predicted in generic formulations?

Small variations in formulation can affect bioequivalence. However, with simultaneous dissolution-permeation testing, true absorption potential is revealed. Generic drugs are essential for increasing ...
Pharmabiz

CDSCO implements prior intimation system for certain drugs under amended NDCT Rules

CDSCO implements prior intimation system for certain drugs under amended NDCT Rules: Gireesh Babu, New Delhi Thursday, April ...
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 ...
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 ...