Zobrazeno 1 - 10
of 67
pro vyhledávání: '"Jerome P. Skelly"'
Autor:
Mark J. Rose, Vinod P. Shah, Jeffrey Sailstad, C. T. Viswanathan, Jerome P. Skelly, Brian Booth, Patrick G. Swann, Surendra Bansal, Russell Weiner, Anthony J. Destefano
Publikováno v:
Pharmaceutical Research. 24:1962-1973
The Third AAPS/FDA Bioanalytical Workshop, entitled "Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays" was held on May 1-3, 2006 in Arlington, VA. The format of this worksh
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a3e6bc07f928d3ccb45df7e95480591
https://doi.org/10.1007/s11095-007-9291-7
https://doi.org/10.1007/s11095-007-9291-7
Publikováno v:
Drug Discovery Today. 10:682-685
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e39915048856b62bd8e831cca5de53b7
https://doi.org/10.1016/s1359-6446(05)03437-9
https://doi.org/10.1016/s1359-6446(05)03437-9
Publikováno v:
Pharmaceutical Research. 15:1321-1325
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d4b29dca2ead74b5b4ebf47ba98392e8
https://doi.org/10.1023/a:1011972732530
https://doi.org/10.1023/a:1011972732530
Autor:
Carol Noory, B.N. Srinivasan, Assad Noory, Jerome P. Skelly, Helen Naviasky, Don Fortman, Bruce McCullough, Richard L. Everett, Vinod P. Shah, Sanford Clarke
Publikováno v:
International Journal of Pharmaceutics. 125:99-106
An in vitro procedure for the evaluation of sparingly water-soluble drug products has been developed and tested. The data on several sparingly water-soluble drug products, such as danazol capsules, megestrol acetate tablets, prazosin HCl capsules, an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::171ec62bed9b83ce6636933a10bf686c
https://doi.org/10.1016/0378-5173(95)00123-z
https://doi.org/10.1016/0378-5173(95)00123-z
Autor:
Vinod P. Shah, Carl C. Peck, Gerhard Levy, Jerome J. Schentag, Leslie Z. Benet, Lewis B. Sheiner, Thomas M. Ludden, Avraham Yacobi, John G. Harter, Daniel E. Furst, Jerome P. Skelly, William H. Barr, C. T. Viswanathan, Lilly P. Sanathanan, Jerry M. Collins, John H. Rodman, Judi Weissinger, Robert E. Desjardins, Donald R. Stanski, Robert Temple
Publikováno v:
The Journal of Clinical Pharmacology. 34:111-119
This report derives from the conference on ‘The Integration of Pharmacokinetic, Pharmacodynamic and Toxicokinetic Principles in Rational Drug Development,’ held on April 24–26, 1991 in Arlington, VA. The conference was sponsored by the American
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5406a2e97ec4e6022d016d574e1723b6
https://doi.org/10.1002/j.1552-4604.1994.tb03974.x
https://doi.org/10.1002/j.1552-4604.1994.tb03974.x
Autor:
T. Feldman, D. R. Savello, Jonas C. T. Wang, R. L. Nedich, R. Jerussi, Lawrence J. Lesko, Vinod P. Shah, G. A. Van Buskirk, J. B. Schwartz, P. Schwartz, R. K. Vanderlaan, H. M. Arbit, S. Dighe, Gordon L. Flynn, Jerome P. Skelly, M. Fawzi, A. S. Kaplan, Stanley L. Hem, Joel L. Zatz, Vivian A. Gray, G. E. Peck, C. Hoiberg, A. Rudman, A. K. Herd, D. M. Pearce, Richard H. Guy, N. Weiner, Mario A. Gonzalez, D. Adair, D. R. Winkel, H. Malinowski, N. M. Meltzer
Publikováno v:
Pharmaceutical Research. 11:1216-1220
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::346ccdae70d6aa754cb83a0bb6082fbf
https://doi.org/10.1023/a:1018913605176
https://doi.org/10.1023/a:1018913605176
Publikováno v:
Journal of Pharmaceutical Sciences. 82:1002-1005
□ The rate and extent of dissolution of various approved marketed carbamazepine (CBZ) tablets exposed to 33,52,75, and 97% relative humidities at both room temperature and 40 °C, and saturated water vapor at room temperature were compared to fresh
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4616d21cd2e086f0f31de0823530a5d4
https://doi.org/10.1002/jps.2600821004
https://doi.org/10.1002/jps.2600821004
Autor:
Jerome P. Skelly, G. F. Shiu
Publikováno v:
European Journal of Drug Metabolism and Pharmacokinetics. 18:121-129
This paper explains the regulatory and scientific reasons for the regulatory authorities employing dissolution as a key variable for regulatory approval of batch to batch bioequivalence assurance, site of manufacture change, formulation changes, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4672233f19f4a81e93e7525cb2047b69
https://doi.org/10.1007/bf03220015
https://doi.org/10.1007/bf03220015
Autor:
Lawrence J. Lesko, P. Schwartz, Vinod P. Shah, J. B. Schwartz, H. Malinowski, Gordon L. Amidon, F. Theeuwes, Ralph F. Shangraw, Joseph R. Robinson, D. Fox, William H. Barr, J. Clevenger, P. R. Nixon, S. Porter, T. Wheatley, Jerome P. Skelly, Larry L. Augsburger, S. Berge, Mario A. Gonzalez, Lewis J. Leeson, C. Hoiberg, M. Fawzi, S. Dighe, Vivian A. Gray, G. A. Van Buskirk, H. M. Arbit, D. M. Pearce, G. E. Peck, D. R. Savello
Publikováno v:
Pharmaceutical Research. 10:1800-1805
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::af297d97b6741bd8eaaa4a5daad9b89b
https://doi.org/10.1023/a:1018946819849
https://doi.org/10.1023/a:1018946819849
Publikováno v:
Journal of Pharmaceutical Sciences. 81:1153-1156
An in vitro testing method for measuring the release of nitroglycerin from topical drug products was evaluated. The method involved measuring the amount of nitroglycerin that diffused from ointments and patches through various synthetic membranes int
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6ff1301a644f1e3e5cf192d96aa37014
https://doi.org/10.1002/jps.2600811204
https://doi.org/10.1002/jps.2600811204