Camargo

DECEMBER 22, 2021

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.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

FEBRUARY 10, 2021

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.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

XTalks

NOVEMBER 6, 2024

The stable gel matrix holds multiple ingredients, offering targeted release and enhanced bioavailability while optimizing patient experience. This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

Camargo

JULY 8, 2021

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 FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .

Development 130

Development Bioequivalency Gene Expression Drugs 130

FDA Law Blog

JULY 6, 2021

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.

Bioequivalency 52

Bioequivalency Bioavailability Regulation Drugs 52

The Pharma Data

APRIL 11, 2023

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.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40