Zobrazeno 1 - 10
of 51
pro vyhledávání: '"D. M. Barends"'
Autor:
Sabine Kopp, Kamal K. Midha, D. M. Barends, Salomon A Stavchansky, Stefanie Strauch, Jennifer B. Dressman, Ekarat Jantratid, Vinod P. Shah, H. E. Junginger
Publikováno v:
Journal of Pharmaceutical Sciences. 100:2054-2063
Literature data relevant to the decision to allow a waiver of in vivo bioequiva- lence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing lamivudine as the only active pharmaceutical ingredient were reviewed. T
Autor:
Sabine Kopp, Stefanie Strauch, Ekarat Jantratid, D. M. Barends, Kamal K. Midha, H. E. Junginger, Salomon A Stavchansky, Jennifer B. Dressman, Vinod P. Shah
Publikováno v:
Journal of Pharmaceutical Sciences. 100:11-21
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing mefloquine hydrochloride as the only active pharmaceutical ingredient (API) are
Autor:
Ekarat Jantratid, Vinod P. Shah, Sabine Kopp, Gordon L. Amidon, Kamal K. Midha, Jennifer B. Dressman, C. Becker, H. E. Junginger, Stefanie Strauch, D. M. Barends, Salomon A Stavchansky
Publikováno v:
Journal of Pharmaceutical Sciences. 99:1639-1653
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing doxycycline hyclate are reviewed. According to the Biopharmaceutics Classi
Autor:
B. Chuasuwan, Jennifer B. Dressman, V. Binjesoh, V. P. Shah, Gordon L. Amidon, Salomon A Stavchansky, H. Zhang, Kamal K. Midha, H. E. Junginger, D. M. Barends, James E. Polli
Publikováno v:
Journal of Pharmaceutical Sciences. 98:1206-1219
Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac so
Autor:
I. González-Alvarez, J. Arnal, Jennifer B. Dressman, Marival Bermejo, Vinod P. Shah, D. M. Barends, Kamal K. Midha, Sabine Kopp, Gordon L. Amidon, H. E. Junginger, Salomon A Stavchansky
Publikováno v:
Journal of Pharmaceutical Sciences. 97:5061-5073
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeu
Autor:
D. M. Barends, Sabine Kopp, Jennifer B. Dressman, Salomon A Stavchansky, H. E. Junginger, A. G. Stosik, Kamal K. Midha, Vinod P. Shah
Publikováno v:
Journal of Pharmaceutical Sciences. 97:3700-3708
Literature data are reviewed relevant to the decision for a biowaiver of immediate release (IR) solid oral dosage forms containing metoclopramide hydrochloride. In addition, new solubility data, obtained under Biopharmaceutics Classification System (
Autor:
Jennifer B. Dressman, Sabine Kopp, Kamal K. Midha, Marcela Raquel Longhi, H. E. Junginger, C. Becker, Gladys E. Granero, Vinod P. Shah, Salomon A Stavchansky, D. M. Barends
Publikováno v:
Journal of Pharmaceutical Sciences. 97:3691-3699
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing acetazolamide are reviewed. Acetazolamide's solubility and permeability ch
Publikováno v:
Current Drug Delivery, 5(2), 142-147
The therapeutic index (TI) of locally acting inhaled drug products depends on a number of parameters and processes: the particle size distribution of the inhaled aerosol, the dose-efficacy response curves at the deposition sites, the amount of drug a
Autor:
Kamal K. Midha, Salomon A Stavchansky, D. M. Barends, C. Becker, Sabine Kopp, Gordon L. Amidon, H. E. Junginger, Jennifer B. Dressman, Vinod P. Shah
Publikováno v:
Journal of Pharmaceutical Sciences. 97:1350-1360
Literature data relevant to the decision to allow a waiver of in vivo bioequi- valence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient
Autor:
D. M. Barends, Sabine Kopp, Gordon L. Amidon, Vinod P. Shah, C. Becker, Kamal K. Midha, H. E. Junginger, Salomon A Stavchansky, Jennifer B. Dressman
Publikováno v:
Journal of Pharmaceutical Sciences. 96:522-531
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing isoniazid as the only active pharmaceutical ingredient (API) are reviewed.