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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate.
Plano, David; Rudolph, Niklas; Saal, Christoph; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Kambayashi, Atsushi; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E; Shah, Vinod P; Charoo, Naseem; Dressman, Jennifer.
Affiliation
  • Plano D; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, 60596 Frankfurt am Main, Germany.
  • Rudolph N; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, 60596 Frankfurt am Main, Germany.
  • Saal C; Boehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach an der Riß, Germany.
  • Abrahamsson B; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca Gothenburg, Sweden.
  • Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida 32827, USA.
  • Kambayashi A; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Japan.
  • Langguth P; Institute of Pharmacy, Johannes Gutenberg University, Mainz, Germany.
  • Mehta M; United States Food and Drug Administration, Centre for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.
  • Parr A; BioCeutics LLC, Cary , North Carolina 27511, USA.
  • Polli JE; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 20742, USA.
  • Shah VP; The International Pharmaceutical Federation (FIP), The Hague, the Netherlands.
  • Charoo N; Adcan Pharma LLC, ICAD III, Mussafah, Abu Dhabi, United Arab Emirates.
  • Dressman J; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, 60596 Frankfurt am Main, Germany. Electronic address: jennifer.dressman@itmp.fraunhofer.de.
J Pharm Sci ; 113(2): 386-395, 2024 02.
Article in En | MEDLINE | ID: mdl-37951471
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pyridines / Triazoles / Prodrugs / Nitriles Language: En Journal: J Pharm Sci Year: 2024 Document type: Article Affiliation country: Germany Country of publication: United States
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pyridines / Triazoles / Prodrugs / Nitriles Language: En Journal: J Pharm Sci Year: 2024 Document type: Article Affiliation country: Germany Country of publication: United States