Literature DB >> 9269503

Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.

H Malinowski, P Marroum, V R Uppoor, W Gillespie, H Y Ahn, P Lockwood, J Henderson, R Baweja, M Hossain, N Fleischer, L Tillman, A Hussain, V Shah, A Dorantes, R Zhu, H Sun, K Kumi, S Machado, V Tammara, T E Ong-Chen, H Mahayni, L Lesko, R Williams.   

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Year:  1997        PMID: 9269503     DOI: 10.1007/978-1-4684-6036-0_25

Source DB:  PubMed          Journal:  Adv Exp Med Biol        ISSN: 0065-2598            Impact factor:   2.622


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  82 in total

1.  In vivo-in vitro correlation (IVIVC) modeling incorporating a convolution step.

Authors:  T O'Hara; S Hayes; J Davis; J Devane; T Smart; A Dunne
Journal:  J Pharmacokinet Pharmacodyn       Date:  2001-06       Impact factor: 2.745

Review 2.  Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making.

Authors:  J V Gobburu; P J Marroum
Journal:  Clin Pharmacokinet       Date:  2001       Impact factor: 6.447

3.  In silico prediction of optimal in vivo delivery properties using convolution-based model and clinical trial simulation.

Authors:  Roberto Gomeni; Carla Dangeli; Alan Bye
Journal:  Pharm Res       Date:  2002-01       Impact factor: 4.200

4.  Bias in the Wagner-Nelson estimate of the fraction of drug absorbed.

Authors:  Yibin Wang; Jerry Nedelman
Journal:  Pharm Res       Date:  2002-04       Impact factor: 4.200

5.  Improving of the accuracy of in vitro-in vivo linear correlation using kinetic models for ultra sustained release theophylline tablets.

Authors:  E Karasulu; S Aktogu; H Y Karasulu; A Aydogdu; I Tuglular; G Ertan
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2003 Oct-Dec       Impact factor: 2.441

6.  FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms.

Authors:  Martin Siewert; Jennifer Dressman; Cynthia K Brown; Vinod P Shah
Journal:  AAPS PharmSciTech       Date:  2003       Impact factor: 3.246

7.  A semi-mechanistic modeling strategy to link in vitro and in vivo drug release for modified release formulations.

Authors:  Martin Bergstrand; Erik Söderlind; Ulf G Eriksson; Werner Weitschies; Mats O Karlsson
Journal:  Pharm Res       Date:  2011-09-27       Impact factor: 4.200

8.  Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.

Authors:  Robert A Lionberger; Andre S Raw; Stephanie H Kim; Xinyuan Zhang; Lawrence X Yu
Journal:  Pharm Res       Date:  2012-01-26       Impact factor: 4.200

9.  Development of In Vitro-In Vivo Correlation for Potassium Chloride Extended Release Tablet Formulation Using Urinary Pharmacokinetic Data.

Authors:  Rajendar K Mittapalli; Patrick Marroum; Yihong Qiu; Kathleen Apfelbaum; Hao Xiong
Journal:  Pharm Res       Date:  2017-05-16       Impact factor: 4.200

10.  In Vitro and In Vivo Correlation of Bone Morphogenetic Protein-2 Release Profiles from Complex Delivery Vehicles.

Authors:  Maurits G L Olthof; Marianna A Tryfonidou; Mahrokh Dadsetan; Wouter J A Dhert; Michael J Yaszemski; Diederik H R Kempen; Lichun Lu
Journal:  Tissue Eng Part C Methods       Date:  2018-07       Impact factor: 3.056

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