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FDA Issues Draft Guidance on Data Integrity Considerations for Bioavailability and Bioequivalence Studies

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...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

Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of Hallucination-like Behavior

Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog pharmacokinetic (PK) studies while significant ...
RAPS

Health Canada Proposes Waiver for Bioavailability Studies

Health Canada has released a new draft guidance document proposing to allow the waiver of bioavailability studies in support of marketing authorization applications for immediate-release, ...
News Medical

Validation criteria for a jejunum-hepatocyte dual-organ MPS for drug ADME studies

This article is based on a poster originally authored by Yassen Abbas, Hailey Sze, Christiana Skarlatopoulou, Ashley A. Spreen, Elizabeth M. Boazak, William R. Thelin, and Tomasz Kostrzewski which was ...
Business Wire

Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of Hallucination-like Behavior

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogen small molecule ...