In a follow-up analysis to the pivotal TOPAZ-1 study, which established the combination therapy of durvalumab (an ...

NMDPSM, a global nonprofit leader in cell therapy, and its collaborative research program, CIBMTR (Center for International ...

The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised ...

The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended ...

This study was designed to investigate, in accordance with international regulatory guidelines, the bioequivalence of two omeprazole products following single- and multiple-dose administration, as ...

Sri Lanka’s drive to boost local pharmaceutical manufacturing is running up against a critical bottleneck: the scarcity of bioequivalence testing facilities. For Sri Lankan drug makers trying to prove ...

The National Agency for Food and Drug Administration and Control has announced that all generic medicines in Nigeria must now undergo bioequivalence (BE) studies before they can be approved. The ...

NAFDAC has announced that all generic medicines in Nigeria must now undergo bioequivalence (BE) studies before they can be approved.

The National Agency for Food and Drug Administration and Control (NAFDAC) has rolled out a groundbreaking regulatory framework requiring bioequivalence (BE) studies for all generic drug products in ...

Refer to the US Center for Veterinary Medicine (CVM) Guidance for Industry #35 "Bioequivalence Guidance" and VICH GL52 "Blood level bioequivalence study" for additional information. Blood level ...

Finally, this approach was validated according to the ICH M10 bioanalytical guidelines, effectively handling concentration ratios of TBI to FCM up to 1:400. Subsequently, the developed methodology was ...