Zobrazeno 1 - 10
of 67
pro vyhledávání: '"Sanford Bolton"'
Autor:
Charles Bon, Sanford Bolton
Publikováno v:
Clinical Research and Regulatory Affairs. 25:119-137
PARALLEL DESIGN IN BIOEQUIVALENCE STUDIES The great majority of bioequivalence (BE) studies measure drug concentrations in body fluids, such that products can be compared within an individual using crossover designs. In some rare circumstances, this
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::85fe8eecf18c2c544e7c2c0f448eb5f9
https://doi.org/10.1080/10601330802131535
https://doi.org/10.1080/10601330802131535
Autor:
Sanford Bolton
Publikováno v:
The AAPS Journal. 7:E47-E53
The Food and Drug Administration (FDA) Guidance for Bioavailability and Bioequivalence Studies for Levothyroxine has been challenged by companies that manufacture brand-name products. Their contention is that the current guidance does not adequately
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e0b49c3e8a7885524b3759c8200e5d9
https://doi.org/10.1208/aapsj070106
https://doi.org/10.1208/aapsj070106
Autor:
Serpil M. Kislalioglu, Shailesh K. Singh, Sanford Bolton, Mansoor A. Khan, Anees Abdulquadar Karnachi, Srikonda V. Sastry
Publikováno v:
Journal of Controlled Release. 37:131-141
Extended release dosage forms can be prepared by a number of methods and coprecipitation of drugs with polymers is one of them. Coprecipitation in turn can be achieved by several methods and dissolution of drugs and polymer in a solvent followed by t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::38636525d465f8c0ba32060f2242555d
https://doi.org/10.1016/0168-3659(95)00073-h
https://doi.org/10.1016/0168-3659(95)00073-h
Publikováno v:
Journal of Controlled Release. 31:229-236
In vitro iontophoretic transdermal delivery (ITD) at a continuous current density of 0.1 mA/cm2 of cromolyn sodium (CS) across hairless guinea pig skin (HGP) was studied with and without enhancers. CS was quantitated by a sensitive HPLC method. At a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9da6a1a36c865970e49526c3d62d2866
https://doi.org/10.1016/0168-3659(94)90004-3
https://doi.org/10.1016/0168-3659(94)90004-3
Publikováno v:
Journal of Controlled Release. 30:253-261
In vitro iontophoretic transdermal delivery (ITD) of a tripeptide, enalaprilat (EP) and a non-peptide, cromolyn sodium (CS), across frozen hairless guinea pig (HGP) skin were investigated. Parameters for optimization of ITD included the influence of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8c6ba9d74e9cdfc9b6069a975df9f460
https://doi.org/10.1016/0168-3659(94)90031-0
https://doi.org/10.1016/0168-3659(94)90031-0
Autor:
Sanford Bolton
Publikováno v:
Clinical Research and Regulatory Affairs. 10:159-175
The problem of what to do with data that appear to be erroneous, but for which no cause is apparent, has puzzled scientists for as long as data have been collected and evaluated. These data can be characterized as outliers, not appearing to be of the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b9cbb2071213f20915d30e6d2a1bb3c8
https://doi.org/10.3109/10601339309014395
https://doi.org/10.3109/10601339309014395
Autor:
Sanford Bolton
Publikováno v:
Clinical Research and Regulatory Affairs. 10:221-232
In a recent landmark decision resulting from a trial involving the Federal Government and Barr Laboratories, Judge Wolin made many judgments based on his constant probing and the testimony of expert witnesses (1). Remarkably, most of what he had to s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b9b4e0fe2ff6fa4e735ebd88f07ba15c
https://doi.org/10.3109/10601339309079569
https://doi.org/10.3109/10601339309079569
Autor:
Subhash Desai, Sanford Bolton
Publikováno v:
Pharmaceutical Research. 10:1321-1325
A novel floating controlled-release drug delivery system was formulated in an effort increase the gastric retention time of the dosage form and to control drug release. The buoyancy was attributed to air and oil entrapped in the agar gel network. A f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ed5d03eaeabf472cc76fc1186fb5bf0d
https://doi.org/10.1023/a:1018921830385
https://doi.org/10.1023/a:1018921830385
Autor:
Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, Avraham Yacobi, Thomas Layloff, C.T. Viswanathan, C.Edgar Cook, R.D. McDowall, Kenneth A. Pittman, Sidney Spector, Kenneth S. Albert, Sanford Bolton, Michael Dobrinska, William Doub, Michael Eichelbaum, John W.A. Findlay, Keith Gallicano, William Garland, Dwight J. Hardy, James D. Hulse, H.Thomas Karnes, Ron Lange, William D. Mason, Gordon McKay, Eric Ormsby, James Overpeck, H.D. Plattenberg, Gerald Shiu, Daniel Sitar, Fritz Sorgel, James T. Stewart, L. Yuh
Publikováno v:
International Journal of Pharmaceutics. 82:1-7
This is a summary report of the conference on ‘Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies.’ The conference was held from December 3 to 5, 1990, in the Washington, DC area and was sponsored by the Am
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f344652d92c8c02a9f6b1da123dd8fb7
https://doi.org/10.1016/0378-5173(92)90065-a
https://doi.org/10.1016/0378-5173(92)90065-a
Autor:
Charles Bon, Sanford Bolton
Publikováno v:
Pharmaceutical Statistics ISBN: 9780429147678
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::049ada03f79b741c3f16777b47079dd4
https://doi.org/10.3109/9781420074239-6
https://doi.org/10.3109/9781420074239-6
