Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Garth, Boehm"'
Publikováno v:
Acta Pharmaceutica Sinica B, Vol 6, Iss 1, Pp 79-92 (2016)
Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk asses
Externí odkaz:
https://doaj.org/article/a85b234264e44d619d68316d0ab4e392
Publikováno v:
Acta Pharmaceutica Sinica B, Vol 3, Iss 5, Pp 297-311 (2013)
The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence
Externí odkaz:
https://doaj.org/article/0d2193c903f14452a1cafb9c8d7f73ed
Publikováno v:
Value in Health. 20:792-798
Background A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no anal
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5f2936032d9a85c849b42f2c4fb505c8
https://doi.org/10.1016/j.jval.2016.05.003
https://doi.org/10.1016/j.jval.2016.05.003
Publikováno v:
Acta Pharmaceutica Sinica B, Vol 6, Iss 1, Pp 79-92 (2016)
Acta Pharmaceutica Sinica. B
Acta Pharmaceutica Sinica. B
Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk asses
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a2537e00ae3861794b4b6046dbe5a643
http://www.sciencedirect.com/science/article/pii/S2211383515001410
http://www.sciencedirect.com/science/article/pii/S2211383515001410
Publikováno v:
Biopharmaceutics & Drug Disposition. 11:93-105
A three-way crossover study was performed to compare the bioavailability of a new pelletised doxycycline product administered either with food or without food and a reference product taken without food. Four different methods were used to calculate p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::06a4b9c54f8c21cbbb34f27f0ba8f181
https://doi.org/10.1002/bdd.2510110202
https://doi.org/10.1002/bdd.2510110202
Autor:
Garth, Boehm, Jon, Clark, John, Dietrick, Laura, Foust, Thomas, Garcia, Muralidhara, Gavini, Jean-Marie, Geoffroy, Pedro, Jimenez, Gerald, Mergen, Fernando, Muzzio, Jerry, Planchard, James, Prescott, Jozef, Timmermans, Neeru, Takiar, David, Whiteman
Publikováno v:
PDA journal of pharmaceutical science and technology. 58(2)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::e310e4bfaf46044b8b73f6b0db4beb42
https://pubmed.ncbi.nlm.nih.gov/15113072
https://pubmed.ncbi.nlm.nih.gov/15113072
Autor:
Garth, Boehm, Jon, Clark, John, Dietrick, Laura, Foust, Thomas, Garcia, Muralidhara, Gavini, Loren, Gelber, Jean-Marie, Geoffroy, Jack, Hoblitzell, Pedro, Jimenez, Gerald, Mergen, Fernando, Muzzio, Jerry, Planchard, James, Prescott, Jozef, Timmermans, Neeru, Takiar
Publikováno v:
PDA journal of pharmaceutical science and technology. 57(2)
In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::de739056ec218ce5db653a54136b0524
https://pubmed.ncbi.nlm.nih.gov/14674508
https://pubmed.ncbi.nlm.nih.gov/14674508
Autor:
Mark Dwyer, Antonio C. Penna, Lloyd Sansom, Raelene J. West, Desmond B. Williams, Garth Boehm
Publikováno v:
Biopharmaceuticsdrug disposition. 11(2)
Eighteen healthy, non-smoking, adult volunteers participated in single and multiple dose three-way crossover studies to evaluate a sustained-release, pellet-filled capsule of theophylline, Austyn. The effect of food on the bioavailability of the sust
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac21c7b896a35600230eb318ca8874a0
https://pubmed.ncbi.nlm.nih.gov/2328301
https://pubmed.ncbi.nlm.nih.gov/2328301
Publikováno v:
Journal of biological standardization. 14(3)
Large plate bioassays are normally assessed by analysis of variance. The British Pharmacopoeial approach requires a validation of the assay through a test for parallelism. This approach is shown to be impractical as it does not allow for improvements
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b8cfc78438216ec42035814f9b43fc7
https://pubmed.ncbi.nlm.nih.gov/3759999
https://pubmed.ncbi.nlm.nih.gov/3759999
Autor:
Les Beyer, D. J. C. Shearman, Renato Morona, Garth Boehm, J. T. Labrooy, Bruce D. Forrest, Stephen R. Attridge, Derrick Rowley
Publikováno v:
The Journal of infectious diseases. 159(1)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f04eed1fd39dda1ad7a4ebf29e91d792
https://pubmed.ncbi.nlm.nih.gov/2909633
https://pubmed.ncbi.nlm.nih.gov/2909633