Zobrazeno 1 - 10
of 23
pro vyhledávání: '"Alan F. Parr"'
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
Autor:
Rodrigo Cristofoletti, Mehul Mehta, Tomokazu Tajiri, Jennifer B. Dressman, Peter Langguth, James E. Polli, Naseem A. Charoo, Hassan A. Hassan, Daud Baraka Abdallah, Ahmed Abdalla Bakheit, Bertil Abrahamsson, Vinod P. Shah, Kashif Ul Haque, Alan F. Parr
Publikováno v:
Journal of Pharmaceutical Sciences. 111:2-13
Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this monograph to assess whether methods based on the Biopharmaceutics Classification System (BCS)
Autor:
Mehul Mehta, Rodrigo Cristofoletti, Peter Langguth, Alan F. Parr, Mauricio A. García, James E. Polli, Vinod P. Shah, D.W. Groot, Bertil Abrahamsson, Jennifer B. Dressman, Tajiri Tomakazu
Publikováno v:
Journal of pharmaceutical sciences. 110(5)
Literature relevant to assessing whether BCS-based biowaivers can be applied to immediate release (IR) solid oral dosage forms containing carbamazepine as the single active pharmaceutical ingredient are reviewed. Carbamazepine, which is used for the
Autor:
Alan F. Parr, Yan Shu, James E. Polli, Vinod P. Shah, D.W. Groot, Bertil Abrahamsson, Peter Langguth, Rodrigo Cristofoletti, Melissa Metry, Mehul Mehta, Jennifer B. Dressman, Tomokazu Tajiri
Publikováno v:
Journal of pharmaceutical sciences. 110(4)
Data are examined regarding possible waiver of in vivo bioequivalence testing (i.e. biowaiver) for approval of metformin hydrochloride (metformin) immediate-release solid oral dosage forms. Data include metformin's Biopharmaceutics Classification Sys
Autor:
Rodrigo Cristofoletti, Daud Baraka Abdallah, Thahera Parveen, Jennifer B. Dressman, Mehul Mehta, Naseem A. Charoo, Bertil Abrahamsson, D.W. Groot, Vinod P. Shah, James E. Polli, Alan F. Parr, Peter Langguth, Tomokazu Tajiri
Publikováno v:
Journal of pharmaceutical sciences. 109(9)
In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid oral d
Autor:
Jennifer B. Dressman, Rodrigo Cristofoletti, Bertil Abrahamsson, Mehul Mehta, D.W. Groot, Peter Langguth, Tomokazu Tajiri, James E. Polli, Gerlinde F. Plöger, Vinod P. Shah, Alan F. Parr
Publikováno v:
Journal of Pharmaceutical Sciences. 107:1761-1772
Literature data relevant to the decision to waive in vivo bioequivalence testing for the approval of generic immediate release solid oral dosage forms of proguanil hydrochloride are reviewed. To elucidate the Biopharmaceutics Classification System (B
Autor:
Jennifer B. Dressman, Dhanusha Thambavita, Mehul Mehta, James E. Polli, Bertil Abrahamsson, Vinod P. Shah, Peter Langguth, Uthpali Mannapperuma, Rodrigo Cristofoletti, Alan F. Parr, Lal Jayakody, D.W. Groot, Priyadarshani Galappatthy
Publikováno v:
Journal of Pharmaceutical Sciences. 106:2930-2945
Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics accor
Autor:
Peter Langguth, Alan F. Parr, Mehul Mehta, Bertil Abrahamsson, Isadore Kanfer, James E. Polli, Raimar Löbenberg, Jennifer B. Dressman, Rodrigo Cristofoletti, Vinod P. Shah, D.W. Groot, Roger K. Verbeeck
Publikováno v:
Journal of Pharmaceutical Sciences. 106:1933-1943
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate-release, solid oral dosage forms containing enalapril maleate are reviewed. Enalapril, a prodrug, is hydrolyzed
Autor:
John R. Crison, Martin Mueller-Zsigmondy, Talia Flanagan, A. Van Peer, Mark McAllister, Uwe Muenster, Peter Timmins, Erik Mannaert, Jeike Biewenga, René Holm, Stefania Beato, S. Page, Stefaan Rossenu, Peter Langguth, Alan F. Parr, Filippos Kesisoglou, Mai Anh Nguyen, R. Li, An Vermeulen, Krista Ojala, Marcus E. Brewster
Publikováno v:
European Journal of Pharmaceutical Sciences. 102:1-13
The present work aimed to describe the current status of IVIVC/IVIVR development in the pharmaceutical industry, focusing on the use and perception of specific approaches as well as successful and failed case studies. Two questionnaires have been dis
Autor:
Michael D. Apley, Mario A. Gonzalez, Jim E. Riviere, Bryan Crist, Sanja Modric, Mark G. Papich, V. Fellner, Alan F. Parr, Marilyn N. Martinez, Margareth Marques, Robert P. Hunter, Janis Messenheimer
Publikováno v:
Dissolution Technologies. 24:36-39
Autor:
Bertil Abrahamsson, Paul M. Quizon, Gerlinde F. Plöger, Rodrigo Cristofoletti, Alan F. Parr, D.W. Groot, Tomokazu Tajiri, Vinod P. Shah, Jennifer B. Dressman, Mehul Mehta, James E. Polli, Peter Langguth
Publikováno v:
Journal of pharmaceutical sciences. 109(6)
Literature data and results of experimental studies relevant to the decision to allow waiver of bioequivalence studies in humans for the approval of immediate release solid oral dosage forms containing cephalexin monohydrate are presented. Solubility