Fast track appraisal (FTA) was adopted by NICE in 2017. This faster and more simplified process is mainly used for novel pharmaceutical agents that are considered bioequivalent to an already recommended drug with added advantages or reduced costs. In June 2022 FTA recommend diroximel fumarate (Vumerity) the management of relapsing remitting multiple sclerosis (RRMS). short article explores pote...

Natural or synthetic? Several petrosaspongiolide M natural and synthetic analogues have been tested as proteasome inhibitors and apoptosis modulators. The natural petrosaspongiolide M congeners gave a consistent decrease in activity. Among the synthetic analogues, the introduction of the benzothiophene ring resulted in a bioequivalent alternative of the petrosaspongiolide M terpenoid system.

OBJECTIVE The objectives of these two studies were to determine if beads from extended-release topiramate capsules sprinkled onto soft food are bioequivalent to the intact capsule and if beads from the capsule can be passed through enteral gastrostomy (G-) and jejunostomy (J-) feeding tubes. METHODS Bioequivalence of 200-mg USL255 (Qudexy XR [topiramate] extended-release capsules) sprinkled o...

AIM Circulating concentrations of endogenous compounds such as testosterone, complicate the analysis of pharmacokinetic parameters when these compounds are administered exogenously. This study examines the influence of three correction methods of accounting for endogenous concentrations on the determination of bioequivalence between two testosterone formulations. METHODS 12 healthy males rece...

PURPOSE The purpose of this computer simulation was to determine the likelihood of two bioequivalent (vs. reference) generic warfarin formulations (with varying bioavailability) passing current bioequivalence criteria against each other at varying bioavailability. Methods. A bioequivalence simulation program generated 100 warfarin bioequivalence (BE) studies with 24 patients/study. The referenc...

The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the name brand drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual signiic...

Essential biological systems employ self-correcting mechanisms to maintain cellular homeostasis. Mammalian cell function is dynamically regulated by the interaction of cell surface galectins with branched N-glycans. Here we report that N-glycan branching deficiency triggers the Golgi to generate bioequivalent N-glycans that preserve galectin-glycoprotein interactions and cellular homeostasis. G...

Demonstratingbioequivalence (BE) is important for the development of lower cost genericproducts, and also approving post-submission manufacturing changes.However, many complex parenteral products, BE demonstration can be verychallenging. For example, long-acting injectable products are engineered tohave an extended release over several weeks or months, but this means thata traditional study tak...