In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG..
Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model. Based on the translational link between in vitro, in silico, and in vivo, virtual bioequivalence study can evaluate the similarity and potential difference of pharmacokinetic and clinical performance between test and reference formulations. With the aid of virtual bioequivalence study, the pivotal information of clinical trials can be provided to streamline the development for both new and generic drugs. However, a regulatory framework of virtual bioequivalence study has not reached its full maturity. Therefore, this article aims to present an overview of the current status of bioequivalence study, identify the framework of virtual bioequivalence studies for oral drugs, and also discuss the future opportunities of virtual bioequivalence in supporting the waiver and optimization of in vivo clinical trials.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:60 |
|---|---|
| Enthalten in: |
Clinical pharmacokinetics - 60(2021), 11 vom: 27. Nov., Seite 1373-1385 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Zhang, Fan [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Drugs, Generic |
|---|
| Anmerkungen: |
Date Completed 25.11.2021 Date Revised 07.09.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s40262-021-01045-7 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM327381043 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM327381043 | ||
| 003 | DE-627 | ||
| 005 | 20231225200648.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40262-021-01045-7 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1091.xml |
| 035 | |a (DE-627)NLM327381043 | ||
| 035 | |a (NLM)34191255 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Zhang, Fan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.11.2021 | ||
| 500 | |a Date Revised 07.09.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG. | ||
| 520 | |a Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model. Based on the translational link between in vitro, in silico, and in vivo, virtual bioequivalence study can evaluate the similarity and potential difference of pharmacokinetic and clinical performance between test and reference formulations. With the aid of virtual bioequivalence study, the pivotal information of clinical trials can be provided to streamline the development for both new and generic drugs. However, a regulatory framework of virtual bioequivalence study has not reached its full maturity. Therefore, this article aims to present an overview of the current status of bioequivalence study, identify the framework of virtual bioequivalence studies for oral drugs, and also discuss the future opportunities of virtual bioequivalence in supporting the waiver and optimization of in vivo clinical trials | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Review | |
| 650 | 7 | |a Drugs, Generic |2 NLM | |
| 650 | 7 | |a Pharmaceutical Preparations |2 NLM | |
| 700 | 1 | |a Jia, Ranran |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Huitao |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Xiaofei |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Hongyun |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical pharmacokinetics |d 1993 |g 60(2021), 11 vom: 27. Nov., Seite 1373-1385 |w (DE-627)NLM000147567 |x 1179-1926 |7 nnns |
| 773 | 1 | 8 | |g volume:60 |g year:2021 |g number:11 |g day:27 |g month:11 |g pages:1373-1385 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40262-021-01045-7 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 60 |j 2021 |e 11 |b 27 |c 11 |h 1373-1385 | ||