Zobrazeno 1 - 10
of 107
pro vyhledávání: '"Avraham Yacobi"'
Publikováno v:
International journal of pharmaceutics. 509(1-2)
Both biopharmaceutics classification system (BCS) and topical drug classification system (TCS) are based on sound scientific principles with the aim of providing biowaiver and reducing regulatory burden without lowering the quality requirements and s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5cffb8528a2b6c90b6be4d8e8b5a9270
https://pubmed.ncbi.nlm.nih.gov/27208656
https://pubmed.ncbi.nlm.nih.gov/27208656
Publikováno v:
International journal of pharmaceutics. 491(1-2)
The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in drug industry and regulatory approval has shown significant progress. This has been the case primarily bec
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b25e94bf99625576ab1f6139ef169b17
https://pubmed.ncbi.nlm.nih.gov/26070249
https://pubmed.ncbi.nlm.nih.gov/26070249
Publikováno v:
Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 9781493912889
This chapter provides a critical overview of the presentations and discussions of a recent workshop “Evaluation of Topical Drug Products—Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies” which brought together ph
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c94d516ff8e1d21bba692a7b1204997f
https://doi.org/10.1007/978-1-4939-1289-6_23
https://doi.org/10.1007/978-1-4939-1289-6_23
Publikováno v:
Topical Drug Bioavailability, Bioequivalence, and Penetration ISBN: 9781493912889
Two categories of tests are performed: (i) product quality tests and (ii) product performance tests. Product quality tests are intended to assess attributes of the dosage form whereas product performance tests are designed to assess the performance o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3c54affbf7577551b43d42eb9821acf6
https://doi.org/10.1007/978-1-4939-1289-6_6
https://doi.org/10.1007/978-1-4939-1289-6_6
Autor:
Avraham Yacobi, Gordon McKay, Krys J. Miller, Vinod P. Shah, Rabindra Patnaik, C. T. Viswanathan, James D. Hulse, Howard Hill, John W. A. Findlay, Kamal K. Midha, Iain J. McGilveray, Alfred P. Tonelli, Mark L. Powell
Publikováno v:
Pharmaceutical Research. 17:1551-1557
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::628097ca2a5897a28b30dd80a857843e
https://doi.org/10.1023/a:1007669411738
https://doi.org/10.1023/a:1007669411738
Autor:
Zohreh Abolfathi, Yechiel Golander, John L. Colaizzi, Eric Masson, Avraham Yacobi, Rakesh Mehta, Steve Zlotnick, Daniel A. Moros, Barrie Levitt, Marc LeBel
Publikováno v:
Clinical Pharmacology & Therapeutics. 65:389-394
Background and Objectives Carbamazepine is among those drugs that have been considered to have a narrow therapeutic plasma concentration range, that is, a narrow therapeutic index. Although the US Food and Drug Administration has approved new generic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b6710be48443441359a1839e5092aa81
https://doi.org/10.1016/s0009-9236(99)70132-3
https://doi.org/10.1016/s0009-9236(99)70132-3
Autor:
Jonathan Wilkin, J.-P. Marty, Thomas J. Franz, Stanley A. Kaplan, Nicholas Fleischer, Gordon L. Flynn, Joel A. Sequeira, Surendra P. Shrivastava, Lawrence J. Lesko, Vinod P. Shah, Charles Bon, Roger L. Williams, Howard I. Maibach, Lynn K. Pershing, Avraham Yacobi, Jeff Kawamoto, Hans Schaefer
Publikováno v:
Skin Pharmacology and Physiology. 11:117-124
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1fca2fa1d2161afad94b588c35972469
https://doi.org/10.1159/000029817
https://doi.org/10.1159/000029817
Autor:
Howard I. Maibach, Avraham Yacobi, Roger L. Williams, Hans Schaefer, Lynn K. Pershing, Lawrence J. Lesko, Nicholas Fleischer, Vinod P. Shah, Jeff Kawamoto, Jonathan Wilkin, Surendra P. Shrivastava, Charles Bon, J.-P. Marty, Gordon L. Flynn, Stanley A. Kaplan, Joel A. Sequeira, Thomas J. Franz
Publikováno v:
Pharmaceutical Research. 15:167-171
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6350120d33646985142b8872d31d5d5c
https://doi.org/10.1023/a:1011941929495
https://doi.org/10.1023/a:1011941929495
Autor:
Isadore Kanfer, Lynn K. Pershing, Eva Benfeldt, Gerald B. Kasting, Guang Wei Lu, Lindsey Katz, Andre Raw, Nathalie Wagner, Edward D. Bashaw, Avraham Yacobi, Barbara M. Davit, Howard I. Maibach, Derek Ganes, Chinmay G. Shukla, Tapash Ghosh, Vinod P. Shah, Majella E. Lane, Kailas Thakker, Robert Lionberger, Russell J. Rackley, Elizabeth Zovko
Publikováno v:
Pharmaceutical research. 31(4)
This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b9179b0d309fca9490d27c78b91ad5ad
https://pubmed.ncbi.nlm.nih.gov/24395404
https://pubmed.ncbi.nlm.nih.gov/24395404
Autor:
Kamal K. Midha, Rabi Patnaik, William H. Barr, Lawrence J. Lesko, Leslie Z. Benet, John Hooper, Andre J. Jackson, Vinod P. Shah, Patrick K. Noonan, William R. Gillespie, William R. Fairweather, Roger L. Williams, Mario A. Gonzalez, Michael R. Dobrinska, Lazslo Endrenyi, Douwe D. Breimer, Avraham Yacobi
Publikováno v:
Pharmaceutical Research. 13:1590-1594
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::06bcb7c5bd74600299337db9926ae3c1
https://doi.org/10.1023/a:1016468018478
https://doi.org/10.1023/a:1016468018478