The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference

Mehta, Mehul; Blume, Henning; Beuerle, Gerald; Tampal, Nilufer; Schug, Barbara; Potthast, Henrike; Jiang, Wenlei; Wilson, Clive

doi:10.1016/j.ejps.2020.105383

Cited by 8 publications

(2 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As a comparison, approximately 69.8% of EMA PSGs for IR solid oral products recommend a fasting BE study, 14.3% recommend a fed BE study, and 15.9% recommend both fasting and fed BE studies (Table 2). The PK BE study recommendation with regard to food represents an area that is significantly different between FDA and EMA, and other regulatory agencies 11–13 …”

Section: Resultsmentioning

confidence: 99%

“…The PK BE study recommendation with regard to food represents an area that is significantly different between FDA and EMA, and other regulatory agencies. [11][12][13] There may be special consideration in the products' labeling on how to take the drug product for ODTs, chewable and effervescent tablets, oral powders, and troches/ lozenges. Administrative instructions were found to not be consistent among different products of the same dosage form.…”

Section: Special Administration Considerations In Ema Psgsmentioning

confidence: 99%

See 1 more Smart Citation

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Kotsybar,

Hakeem,

Zhang

et al. 2023

Clinical Translational Sci

Self Cite

View full text Add to dashboard Cite

Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product‐specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA‐approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi‐solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Special Administration Considerations In Ema Psgsmentioning

confidence: 99%