FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms M Siewert, J Dressman, CK Brown, VP Shah, JM Aiache, N Aoyagi, ... Aaps Pharmscitech 4, 43-52, 2003 | 559 | 2003 |
New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process SM Huang, JM Strong, L Zhang, KS Reynolds, S Nallani, R Temple, ... The Journal of clinical pharmacology 48 (6), 662-670, 2008 | 420 | 2008 |
Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications VA Bhattaram, BP Booth, RP Ramchandani, BN Beasley, Y Wang, ... The AAPS journal 7, E503-E512, 2005 | 176 | 2005 |
Development and internal validation of an in vitro-in vivo correlation for a hydrophilic metoprolol tartrate extended release tablet formulation ND Eddington, P Marroum, R Uppoor, A Hussain, L Augsburger Pharmaceutical research 15, 466-473, 1998 | 111 | 1998 |
Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making JVS Gobburu, PJ Marroum Clinical pharmacokinetics 40, 883-892, 2001 | 99 | 2001 |
In vitro metabolic interaction studies: experience of the Food and Drug Administration R Yuan, T Parmelee, JD Balian, RS Uppoor, F Ajayi, A Burnett, LJ Lesko, ... Clinical Pharmacology & Therapeutics 66 (1), 9-15, 1999 | 81 | 1999 |
In Vivo Bioequivalence and In Vitro Similarity Factor (f2) for Dissolution Profile Comparisons of Extended Release Formulations: How and When Do They Match? JZ Duan, K Riviere, P Marroum Pharmaceutical research 28, 1144-1156, 2011 | 67 | 2011 |
Applications of clinically relevant dissolution testing: workshop summary report S Suarez-Sharp, M Cohen, F Kesisoglou, A Abend, P Marroum, ... The AAPS Journal 20, 1-14, 2018 | 64 | 2018 |
Pharmacokinetics of upadacitinib with the clinical regimens of the extended‐release formulation utilized in rheumatoid arthritis phase 3 trials MEF Mohamed, J Zeng, PJ Marroum, IH Song, AA Othman Clinical Pharmacology in Drug Development 8 (2), 208-216, 2019 | 61 | 2019 |
In vitro characterization of ritonavir drug products and correlation to human in vivo performance H Xu, S Vela, Y Shi, P Marroum, P Gao Molecular Pharmaceutics 14 (11), 3801-3814, 2017 | 59 | 2017 |
Evaluation of “external” predictability of an in vitro–in vivo correlation for an extended‐release formulation containing metoprolol tartrate H Mahayni, GS Rekhi, RS Uppoor, P Marroum, AS Hussain, ... Journal of pharmaceutical sciences 89 (10), 1354-1361, 2000 | 51 | 2000 |
Metabolites and bioequivalence: past and present AJ Jackson, G Robbie, P Marroum Clinical pharmacokinetics 43, 655-672, 2004 | 49 | 2004 |
Developing quantitative in vitro–in vivo correlation for fenofibrate immediate-release formulations with the biphasic dissolution-partition test method H Xu, Y Shi, S Vela, P Marroum, P Gao Journal of Pharmaceutical Sciences 107 (1), 476-487, 2018 | 45 | 2018 |
Draft Guidance for Industry Extended-Release Solid Oral Dosage Forms: Development, Evaluation and Application of in Vitro-in Vivo Correlations H Malinowski, P Marroum, VR Uppoor, W Gillespie, HY Ahn, P Lockwood, ... In Vitro-in Vivo Correlations, 269-288, 1997 | 43 | 1997 |
Processes for the Preparation of (3S, 4R)-3-ethyl-4-(3H-imidazo [1, 2-alpha] pyrrolo [2, 3-e]-pyrazin-8-yl)-N-(2, 2, 2-trifluoroethyl) pyrrolidine-1-carboxamide and Solid State … A Allian, J Jayanth, ME Mohamed, M Mulhern, LF Nordstroem, A Othman, ... US Patent App. 15/295,561, 2017 | 38 | 2017 |
In vivo drug‐drug interaction studies‐A survey of all new molecular entities approved from 1987 to 1997 PJ Marroum, RS Uppoor, T Parmelee, F Ajayi, A Burnett, R Yuan, ... Clinical Pharmacology & Therapeutics 68 (3), 280-285, 2000 | 35 | 2000 |
Processes for the preparation of (3S, 4R)-3-ethyl-4-(3H-imidazo [1, 2-alpla] pyrrolo [2, 3-e]-pyrazin-8-YL)-N-(2, 2, 2-Trifluoroethyl) pyrrol and solid state forms thereof J Jayanth, PJ Marroum, PT Mayer, MEF Mohamed, AA Othman US Patent 9,963,459, 2018 | 30 | 2018 |
Processes for the preparation of (3S, 4R)-3-ethyl-4-(3H-imidazo [1, 2-# a] pyrrolo [2, 3-e]-pyrazin-8-yl)-N-(2, 2, 2-trifluoroethyl) pyrrolidine-1-# carboxamide and solid state … J Jayanth, PJ Marroum, PT Mayer, MEF Mohamed, AA Othman, B Klünder, ... US Patent 10,344,036, 2019 | 29 | 2019 |
Processes for the preparation of (3S, 4R)-3-ethyl-4-(3H-imidazo [1, 2-α] pyrrolo [2, 3-e]-pyrazin-8-yl)-N-(2, 2, 2-trifluoroethyl) pyrrolidine-1-carboxamide and solid state … J Jayanth, PJ Marroum, PT Mayer, MEF Mohamed, AA Othman, B Klünder US Patent 10,202,393, 2019 | 29 | 2019 |
Processes for the preparation of (3S, 4R)-3-ethyl-4-(3H-imidazo [1, 2-a] pyrrolo [2, 3-e]-pyrazin-8-yl)-N-(2, 2, 2-trifluoroethyl) pyrrolidine-1-carboxamide and solid state … J Jayanth, PJ Marroum, PT Mayer, MEF Mohamed, AA Othman, B Klünder US Patent 10,202,394, 2019 | 29 | 2019 |