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The Composition and Value of a Portfolio Analysis

Camargo

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Biowaiver Eligibility.

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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. The results of the population analysis reveal the average relative bioavailability of the test to reference. The comparison of relative bioavailability based on simulated data then indicates if BE can be achieved.

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Can a CRL Be Final Agency Action: One Step Closer to Finding Out

FDA Law Blog

Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.

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In the News: June 2021 Regulatory and Development Updates

Camargo

In June, the FDA issued an updated (draft) guidance titled “ Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .

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Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

The Pharma Data

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

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Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

FDA Law Blog

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. In Part 3 of the study, which investigated relative bioavailability and food effect, the SDD tablet was assessed in the fed and fasted state and compared back to the reference SDD suspension.