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. Chemistry, Manufacturing, and Controls (CMC) Strategies.

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 Bioequivalency 133

FDA Law Blog

JULY 6, 2021

The CRL was issued on July 21, 2020 on Nostrum’s Prior Approval Supplement ANDA seeking approval to move its manufacturing facilities.

Bioequivalency 52

Bioequivalency Bioavailability Regulation Drugs 52

Pharmaceutical Technology

FEBRUARY 23, 2023

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.

Development 246

Development Drugs Bioavailability In-Vivo 246