Zobrazeno 1 - 10
of 51
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
Autor:
Boehm, Garth
Typescript (photocopy)
v, 184 leaves : ill. ; 30 cm
Title page, contents and abstract only. The complete thesis in print form is available from the University Library.
Thesis (Ph.D.)--Dept. of Physical and Inorganic Chemistry, Universi
v, 184 leaves : ill. ; 30 cm
Title page, contents and abstract only. The complete thesis in print form is available from the University Library.
Thesis (Ph.D.)--Dept. of Physical and Inorganic Chemistry, Universi
Externí odkaz:
http://hdl.handle.net/2440/20212
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
Autor:
Feldman, Robin1
Publikováno v:
Yale Law & Policy Review. Fall2023, Vol. 42 Issue 1, p1-41. 41p.