Zobrazeno 1 - 10
of 50
pro vyhledávání: '"D.W. Groot"'
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b523893cf5b134e4655389c7a700b7fb
https://pubmed.ncbi.nlm.nih.gov/33610571
https://pubmed.ncbi.nlm.nih.gov/33610571
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3617fdd4cee9ef5b72a8748079bd3604
https://pubmed.ncbi.nlm.nih.gov/33450218
https://pubmed.ncbi.nlm.nih.gov/33450218
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b9523f9600e8c361f2750ae47af155ec
https://pubmed.ncbi.nlm.nih.gov/32534881
https://pubmed.ncbi.nlm.nih.gov/32534881
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c4e7723f89a31e44883b5758dce7656
https://doi.org/10.1016/j.xphs.2018.03.009
https://doi.org/10.1016/j.xphs.2018.03.009
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5e3d45db3facb029e9e16a2e4da2e56
https://doi.org/10.1016/j.xphs.2017.04.068
https://doi.org/10.1016/j.xphs.2017.04.068
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::23e86ee9022b9a5c43c797d2597d8a4f
https://doi.org/10.1016/j.xphs.2017.04.019
https://doi.org/10.1016/j.xphs.2017.04.019
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9c17ce1362ae0356fefbb169d76c24e
https://pubmed.ncbi.nlm.nih.gov/32240696
https://pubmed.ncbi.nlm.nih.gov/32240696
Autor:
Alan F. Parr, Tomokazu Tajiri, Bertil Abrahamsson, Jennifer B. Dressman, Mangal S. Nagarsenker, Vinod P. Shah, Rodrigo Cristofoletti, James E. Polli, Peter Langguth, Mehul Mehta, Gopal Singh Rajawat, D.W. Groot, Tejashree Belubbi
Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::13e1fe19bf6d811851b05e91928271b8
http://hdl.handle.net/10029/623205
http://hdl.handle.net/10029/623205
Autor:
Mehul Mehta, Jennifer B. Dressman, Bertil Abrahamsson, Navid Goodarzi, Ahmadreza Barazesh Morgani, Rodrigo Cristofoletti, D.W. Groot, Vinod P. Shah, Peter Langguth, James E. Polli
Publikováno v:
Journal of Pharmaceutical Sciences
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 ribavirin are reviewed. Ribavirin is highly soluble, but its permeability chara
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::69b7899e83425c861c2e8c62432f1f53
https://doi.org/10.1016/j.xphs.2016.01.017
https://doi.org/10.1016/j.xphs.2016.01.017
Autor:
James E. Polli, D.W. Groot, Johannes Krämer, Jayachandar Gajendran, Jennifer B. Dressman, Bertil Abrahamsson, Peter Langguth, Mehul Mehta, Vinod P. Shah, Rodrigo Cristofoletti
Publikováno v:
Journal of Pharmaceutical Sciences. 104:3289-3298
Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are reviewed to evaluate whether a waiver of in vivo bioequivalence (BE) testing of immediate-release (IR) dosage forms formulated a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::24d443360e87e35f8c66b19a264d69a0
https://doi.org/10.1002/jps.24560
https://doi.org/10.1002/jps.24560