Zobrazeno 1 - 10
of 44
pro vyhledávání: '"Sabine Kopp"'
Autor:
Valeria Gigante, Giovanni M. Pauletti, Sabine Kopp, Minghze Xu, Isabel Gonzalez-Alvarez, Virginia Merino, Michelle P. McIntosh, Anita Wessels, Beom-Jin Lee, Kênnia Rocha Rezende, Gerhard K.E. Scriba, Gaurav P. S. Jadaun, Marival Bermejo
Publikováno v:
ADMET and DMPK (2020)
The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in vivo bioequivalence studies. The focus of this study was to engage a global
Externí odkaz:
https://doaj.org/article/5208c09f597b4583abb12e3bc52f96ba
Autor:
Michelle P. McIntosh, Isabel González-Álvarez, Gaurav P. S. Jadaun, Giovanni M. Pauletti, Beom-Jin Lee, Anita Wessels, Virginia Merino, Marival Bermejo, Valeria Gigante, Sabine Kopp, Gerhard K. E. Scriba, Minghze Xu, Kênnia Rocha Rezende
Publikováno v:
ADMET and DMPK (2020)
ADMET and DMPK
Volume 9
Issue 1
ADMET and DMPK
Volume 9
Issue 1
The WHO Biopharmaceutical Classification System (BCS) is a practical tool to identify active pharmaceutical ingredients (APIs) that scientifically qualify for a waiver of in vivo bioequivalence studies. The focus of this study was to engage a global
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::91c27e046c264cc462cf877a8bbcdec2
http://pub.iapchem.org/ojs/index.php/admet/article/view/850
http://pub.iapchem.org/ojs/index.php/admet/article/view/850
Autor:
Sabine Kopp-Kubel, Manuel Zahn
The World Health Organization (WHO), with headquarters in Geneva, Switzerland, is a specialized agency within the Charter of the United Nations with 191 Member States. The WHO was established to assist its Member States in their efforts to promote th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::86cf6ee211c11536ac2160840e6b8795
https://doi.org/10.1201/9781003076087-18
https://doi.org/10.1201/9781003076087-18
Publikováno v:
Biologicals
The innocuity test was indicated as a quality control test to release pharmaceutical and biological products to the market. The test was intended to detect possible extraneous toxic contaminants derived from the manufacturing processes of the product
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::935f1bcb5e90db07cf3c1def8671ca40
https://pubmed.ncbi.nlm.nih.gov/32536585
https://pubmed.ncbi.nlm.nih.gov/32536585
Autor:
Arik Dahan, Jennifer B. Dressman, Omri Wolk, Vinod P. Shah, D.W. Groot, Bertil Abrahamsson, Peter Langguth, James E. Polli, Rodrigo Cristofoletti, Moran Zur, Sabine Kopp, Gordon L. Amidon
Publikováno v:
Journal of Pharmaceutical Sciences. 103:1592-1600
The present monograph reviews data relevant to applying the biowaiver procedure for the approval of immediate-release multisource solid dosage forms containing codeine phosphate. Both biopharmaceutical and clinical data of codeine were assessed. Solu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f54b48821e8634cfa8da563b12f2696
https://doi.org/10.1002/jps.23977
https://doi.org/10.1002/jps.23977
Autor:
Dirk M. Barends, D.W. Groot, I. E. Shohin, Galina V. Ramenskaya, Jennifer B. Dressman, Julia I. Kulinich, Vinod P. Shah, Bertil Abrahamsson, Sabine Kopp, Peter Langguth, James E. Polli
Publikováno v:
Journal of Pharmaceutical Sciences. 103:367-377
Literature and experimental 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 piroxicam in the free acid form are reviewed. Piroxicam s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::29bcf84c2a29e20d9aaf1e6f0765b466
https://doi.org/10.1002/jps.23799
https://doi.org/10.1002/jps.23799
Autor:
Peter Langguth, Rodrigo Cristofoletti, Areeg A. A. Shamsher, Jennifer B. Dressman, Vinod P. Shah, Sabine Kopp, Bertil Abrahamsson, James E. Polli, Lai Y. Lian, Naseem A. Charoo, D.W. Groot
Publikováno v:
Journal of Pharmaceutical Sciences. 103:378-391
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 bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b12cc47c38ab21376ef7029b51304d06
https://doi.org/10.1002/jps.23817
https://doi.org/10.1002/jps.23817
Autor:
James E. Polli, Dirk M. Barends, Vinod P. Shah, Bertil Abrahamsson, Sabine Kopp, D.W. Groot, Anita Nair, Jennifer B. Dressman
Publikováno v:
Journal of Pharmaceutical Sciences. 101:4390-4401
The present monograph reviews data relevant to applying the biowaiver pro- cedure for the approval of immediate release (IR) multisource solid dosage forms containing amodiaquine hydrochloride (ADQ) as the single active pharmaceutical ingredient (API
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9c246e2afb54f6070445fae0e74f5950
https://doi.org/10.1002/jps.23312
https://doi.org/10.1002/jps.23312
Autor:
Vinod P. Shah, Jennifer B. Dressman, Bertil Abrahamsson, Sabine Kopp, I. E. Shohin, D.W. Groot, Julia I. Kulinich, Dirk M. Barends, Peter Langguth, James E. Polli, Galina V. Ramenskaya
Publikováno v:
Journal of Pharmaceutical Sciences. 101:3593-3603
Literature and experimental 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 ketoprofen are reviewed. Ketoprofen's solubility and perm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58421a4fa60f9960b6351be290c73b6b
https://doi.org/10.1002/jps.23233
https://doi.org/10.1002/jps.23233
Autor:
James E. Polli, Jennifer B. Dressman, Sabine Kopp, D.W. Groot, Bertil Abrahamsson, Dirk M. Barends, Vinod P. Shah, Anita Nair
Publikováno v:
Journal of Pharmaceutical Sciences. 101:936-945
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 the antimalarial drug primaquine phosphate as the only active pharmaceutic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7ea02b890e12117ae12fc6d2c1597b74
https://doi.org/10.1002/jps.23006
https://doi.org/10.1002/jps.23006