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

The BA/BE study also assessed the effect of food on the bioavailability of the drug substances in IHL-42X. All participants in the study completed four treatment periods, each consisting of a single ...
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The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and ...
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 ...
PharmTech

FDA Publishes Guidance on Bioavailability and Bioequivalence Samples

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 ...
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Keeping Track of Your Data — What You Need to Know about FDA’s Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
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

FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

The New EMA Bioequivalence Guideline: Key Considerations

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 ...
Mena FN

Bioavailability And Bioequivalence Studies Submitted In Ndas And Inds Webinar

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, April 07, 2025 (GLOBE NEWSWIRE) -- The "Bioavailability and Bioequivalence Studies submitted in NDAs and INDs" training has been added to ...
ascopubs.org

Relative bioavailability (BA) and bioequivalence (BE) study of abiraterone acetate (AA) fine particle (AAFP) with methylprednisolone (MP) and a reference formulation with ...

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 ...
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 ...