In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context-Reference-Cited by-同舟云学术

In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context

Published:2017-03-01 Issue:4 Volume:14 Page:1307-1314
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Lennernäs H.¹,Lindahl A.²,Van Peer A.³,Ollier C.⁴,Flanagan T.⁵,Lionberger R.⁶,Nordmark A.²,Yamashita S.⁷,Yu L.⁸,Amidon G. L.⁹,Fischer V.¹⁰,Sjögren E.¹,Zane P.⁴,McAllister M.¹¹,Abrahamsson B.¹²

Affiliation:

1. Department of Pharmacy, Uppsala University, Uppsala, Sweden

2. Medical Products Agency, Uppsala, Sweden

3. Janssen Research and Development, Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340, Beerse, Belgium

4. Sanofi US, 55 Corporate Drive, Bridgewater, New Jersey 08807, United States

5. AstraZeneca R&D, Macclesfield, U.K.

6. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States

7. Faculty of Pharmaceutical Sciences, Setsunan University, Nagaotoge-cho 45-1, Hirakata, Osaka 573-0101, Japan

8. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, United States

9. College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065, United States

10. Drug Metabolism and Pharmacokinetics, Research & Development, AbbVie, North Chicago, Illinois 60064, United States

11. Pharmaceutical Development, GlaxoSmithKline, New Frontiers Science Park, Harlow, Essex CM19 5AW, United Kingdom

12. AstraZeneca R&D, Gothenburg, Sweden

Funder

Seventh Framework Programme

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.6b00824

Reference20 articles.

1. Oral biopharmaceutics tools – Time for a new initiative – An introduction to the IMI project OrBiTo

2. Early pharmaceutical profiling to predict oral drug absorption: Current status and unmet needs

3. In vitro models for the prediction of in vivo performance of oral dosage forms

4. In vivo methods for drug absorption – Comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects

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