Zobrazeno 1 - 10
of 78
pro vyhledávání: '"Murray P. Ducharme"'
Autor:
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 624-630 (2023)
Abstract 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 Demonstrat
Externí odkaz:
https://doaj.org/article/7ba25868225a4671a0706b3a2c4392e8
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 23 (2020)
Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic bioequivalence studies for European/North American generic submissions appeared to have been conducted in geographical/ethnic populations other than those for which the
Externí odkaz:
https://doaj.org/article/da4404d038fa4f9f959194d42da8c97f
Publikováno v:
Asian Journal of Pharmaceutical Sciences, Vol 10, Iss 6, Pp 461-471 (2015)
Orally inhaled drug products (OIPs), such as corticosteroids and bronchodilators, are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. Introducing generics of these prod
Externí odkaz:
https://doaj.org/article/c64b047788064748b383cb060f3f0c15
Autor:
Deniz Ozdin, Naveen Sharma, Jorge Lujan-Zilbermann, Philippe Colucci, Isadore Kanfer, Murray P. Ducharme
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 21, Iss 1 (2018)
Purpose: As per the US FDA guidance issued on June 2, 1995, the establishment of bioequivalence for topical dermatologic corticosteroids is based on comparing the pharmacodynamic (PD) effects of Test and Reference products at the dose duration corres
Externí odkaz:
https://doaj.org/article/ebcc94ded581475cbc5e658269794438
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 14, Iss 2 (2011)
In noncompartmental analysis, poor characterization of the terminal elimination rate constant (Kel) will lead to biased results for half-life and total exposure (AUCinf), providing incorrect relative bioavailability and bioequivalence conclusions. We
Externí odkaz:
https://doaj.org/article/51c08b3e5a5c4cb7844fce04e6d1fb6b
Autor:
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology. 12:624-630
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4e0d67fd17f6ab9325b746cf4471e58a
https://doi.org/10.1002/psp4.12931
https://doi.org/10.1002/psp4.12931
Autor:
Dinh Bui, Bradley Vince, Khurshida Begum, Kevin W. Garey, Chris Lancaster, Martin Kankam, M. Jahangir Alam, Anne J Gonzales-Luna, Julie Mercier, Ming Hu, Corinne Seng Yue, Murray P. Ducharme, Michael H Silverman
Publikováno v:
Journal of Antimicrobial Chemotherapy
BackgroundClostridioides difficile infection is the most common cause of healthcare-associated infections in the USA, with limited treatment options. Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile.Ob
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::33a94044c54e8c4e319b49ccdbec930c
https://doi.org/10.1093/jac/dkaa364
https://doi.org/10.1093/jac/dkaa364
Publikováno v:
Clinical Pharmacology & Therapeutics. 105:350-362
The science of bioequivalence and biosimilarity has greatly evolved over the past 3 decades. Current methods for assessing bioequivalence mostly rely on noncompartmental pharmacokinetic (PK) analyses, which have proven to be reliable and robust for m
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9ba6fe841926991863ddea97d79444d7
https://doi.org/10.1002/cpt.1270
https://doi.org/10.1002/cpt.1270
Autor:
Donald J. Schuirmann, Barbara Schug, Mehul Mehta, Andreas Brandt, Murray P. Ducharme, Henning Blume, Jan Welink, Mei-Ling Chen, Laszlo Endrenyi, Gerald Beuerle, Keith Gallicano, Henrike Potthast
Publikováno v:
European Journal of Pharmaceutical Sciences. 127:24-28
The Global Bioequivalence Harmonization Initiative (GBHI) was launched by the Network on Bioavailability and Biopharmaceutics (BABP) under the auspices of European Federation for Pharmaceutical Sciences (EUFEPS) several years ago. Since 2015, EUFEPS
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2501c1ad661efd8ce14d847639f938b5
https://doi.org/10.1016/j.ejps.2018.10.019
https://doi.org/10.1016/j.ejps.2018.10.019
Publikováno v:
Pharmaceutical Research. 37
The purpose of this study was (a) to suggest a novel dermatopharmacokinetic (DPK) approach from which pharmacokinetic parameters relevant to the bioequivalence (BE) assessment of a topical formulation can be deduced while circumventing the need for n
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e16a47f2962298a1ae02b6a02a0bfd07
https://doi.org/10.1007/s11095-019-2724-2
https://doi.org/10.1007/s11095-019-2724-2