https://www.fda.gov/drugs/regulatory-science-action/determining-topical-product-bioequivalence-stimulated-raman-scattering-microscopy
Historically, for topical drug products applied to the skin, bioequivalence (BE) has often been established based on comparative clinical endpoint BE studies....
stimulated raman scatteringtopicalproductbioequivalencemicroscopy
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence-0?utm_medium=email&utm_source=govdelivery
Statistical Approaches to Establishing Bioequivalence
statisticalapproachesestablishingbioequivalencefda
https://pubmed.ncbi.nlm.nih.gov/21945487/
Recently, the European Medicines Agency (EMA) issued a new guideline on the investigation of bioequivalence (BE). In case of highly variable drugs, this...
on thelevelingpropertiesnewbioequivalence
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fdamhrahealth-canada-symposium-regulatory-perspectives-good-clinical-practice-bioequivalence-and
This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence and good...
health canadafdamhrasymposiumregulatory
https://www.fda.gov/drugs/news-events-human-drugs/bioequivalence-studies-pharmacokinetic-endpoints-drugs-submitted-under-anda-02242022
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
bioequivalencestudiespharmacokineticdrugssubmitted