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Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products : Summary of workshop

Gong, Yuqing (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
Zhang, Peijue (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
Yoon, Miyoung (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
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Zhu, Hao (author)
US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
Kohojkar, Ameya (author)
Teva Pharmaceut, Regulatory Affairs, Fairfield, NJ USA.
Hooker, Andrew, 1973- (author)
Uppsala universitet,Institutionen för farmaci
Ducharme, Murray P. (author)
Learn & Confirm Inc, St Laurent, PQ, Canada.
Gobburu, Jogarao (author)
Univ Maryland, Ctr Translat Med, Sch Pharm, College Pk, MD USA.
Celliere, Geraldine (author)
Simulat Plus, Lixoft Div, Paris, France.
Gajjar, Parmesh (author)
Seda Pharmaceut Dev Serv, Cheadle, England.
Li, Bing V. (author)
US FDA, Off Bioequivalence, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
Velagapudi, Raja (author)
Sandoz Inc, Ctr Drug Evaluat & Res, Off Res & Stand, Off Gener Drugs, E Hanover, NJ USA.
Tsang, Yu Chung (author)
Apotex Inc, Toronto, ON, Canada.
Schwendeman, Anna (author)
Univ Michigan, Biointerfaces Inst, Dept Pharmaceut Sci, Ann Arbor, MI USA.
Polli, James (author)
Univ Maryland, Sch Pharm, Dept Pharmaceut Sci, College Pk, MD USA.
Fang, Lanyan (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
Lionberger, Robert (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
Zhao, Liang (author)
US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA.
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US FDA, Off Res & Stand, Off Gener Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA. (creator_code:org_t)
2023-02-09
2023
English.
In: CPT. - : John Wiley & Sons. - 2163-8306. ; 12:5, s. 624-630
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https://uu.diva-port... (primary) (Raw object)
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  • Research review (peer-reviewed)
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  • On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled "Establishing the Suitability of Model-Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable (LAI) Drug Products. " This workshop brought relevant parties from the industry, academia, and the FDA in the field of modeling and simulation to explore, identify, and recommend best practices on utilizing MIE for bioequivalence (BE) assessment of LAI products. This report summerized presentations and panel discussions for topics including challenges and opportunities in development and assessment of generic LAI products, current status of utilizing MIE, recent research progress of utilizing MIE in generic LAI products, alternative designs for BE studies of LAI products, and model validation/verification strategies associated with different types of MIE approaches.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

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