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Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries.
Franco, Pedro; Jain, Ritesh; Rosenkrands-Lange, Elizabeth; Hey, Claudia; Koban, Marén U.
Affiliation
  • Franco P; Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, TW14 8HA, Middlesex, UK. pedro.franco@merckgroup.com.
  • Jain R; EMD Serono Research & Development Institute, 1299 Pennsylvania Ave., N.W., Suite 825, Washington, DC, 20004, USA.
  • Rosenkrands-Lange E; EMD Serono Research & Development Institute, 1299 Pennsylvania Ave., N.W., Suite 825, Washington, DC, 20004, USA.
  • Hey C; Merck Healthcare KGaA, Frankfurter Str. 250, F135/K04 64293, Darmstadt, Germany.
  • Koban MU; Merck Healthcare KGaA, Frankfurter Str. 250, F135/K04 64293, Darmstadt, Germany.
Ther Innov Regul Sci ; 57(3): 484-514, 2023 05.
Article in En | MEDLINE | ID: mdl-36463352

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Drug Approval / Drug Development Limits: Humans Country/Region as subject: Oceania Language: En Journal: Ther Innov Regul Sci Year: 2023 Document type: Article Affiliation country: United kingdom Country of publication: Switzerland

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Drug Approval / Drug Development Limits: Humans Country/Region as subject: Oceania Language: En Journal: Ther Innov Regul Sci Year: 2023 Document type: Article Affiliation country: United kingdom Country of publication: Switzerland