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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.
García, Mauricio A; Cristofoletti, Rodrigo; Abrahamsson, Bertil; Groot, Dirk W; Parr, Alan; Polli, James E; Mehta, Mehul; Shah, Vinod P; Tomakazu, Tajiri; Dressman, Jennifer B; Langguth, Peter.
Affiliation
  • García MA; Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany.
  • Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
  • Abrahamsson B; Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden.
  • Groot DW; RIVM (National Institute for Public Health and the Environment), Bilthoven, the Netherlands.
  • Parr A; BioCeutics LLC, Cary, NC, USA.
  • Polli JE; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
  • Mehta M; Division of Clinical Pharmacology, Centre for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
  • Shah VP; International Pharmaceutical Federation (FIP), The Hague, the Netherlands.
  • Tomakazu T; Pharmaceutical Science & Technology Laboratories, Astellas Pharma Inc, Ibaraki, Japan.
  • Dressman JB; Fraunhofer Institute of Translational Medicine and Pharmacology, ITMP, Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address: dressman@em.uni-frankfurt.de.
  • Langguth P; Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany. Electronic address: langguth@uni-mainz.de.
J Pharm Sci ; 110(5): 1935-1947, 2021 05.
Article in En | MEDLINE | ID: mdl-33610571
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Excipients Language: En Journal: J Pharm Sci Year: 2021 Document type: Article Affiliation country: Germany Country of publication: United States
Fulltext
Add to My VHL
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Excipients Language: En Journal: J Pharm Sci Year: 2021 Document type: Article Affiliation country: Germany Country of publication: United States