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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.
McAllister, Mark; Flanagan, Talia; Cole, Susan; Abend, Andreas; Kotzagiorgis, Evangelos; Limberg, Jobst; Mead, Heather; Mangas-Sanjuan, Victor; Dickinson, Paul A; Moir, Andrea; Pepin, Xavier; Zhou, Diansong; Tistaert, Christophe; Dokoumetzidis, Aristides; Anand, Om; Le Merdy, Maxime; Turner, David B; Griffin, Brendan T; Darwich, Adam; Dressman, Jennifer; Mackie, Claire.
Afiliação
  • McAllister M; Pfizer WWRD, Sandwich, Kent CT13 9NJ, UK.
  • Flanagan T; UCB Pharma SA, 1420 Braine l'Alleud, Belgium.
  • Cole S; Medicines & Healthcare Products Regulatory Agency, London E14 4PU, UK.
  • Abend A; Development Sciences and Clinical Supply, Merck & Co., Inc., Rahway, NJ 07033, USA.
  • Kotzagiorgis E; European Medicines Agency, 1083 Amsterdam, The Netherlands.
  • Limberg J; Federal Institute for Drugs and Medical Devices (BfArM), 53175 Bonn, Germany.
  • Mead H; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.
  • Mangas-Sanjuan V; Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, E46100 Burjassot, Spain.
  • Dickinson PA; Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia, 46010 Valencia, Spain.
  • Moir A; SEDA Pharmaceutical Development Sciences, Stockport SKB 3GX, UK.
  • Pepin X; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.
  • Zhou D; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.
  • Tistaert C; Simulations Plus, Inc., Lancaster, CA 93534, USA.
  • Dokoumetzidis A; AstraZeneca Boston, Boston, MA 02451, USA.
  • Anand O; Janssen Research and Development, 2340 Beerse, Belgium.
  • Le Merdy M; Department of Pharmacy, National and Kapodistrian University of Athens, 15784 Athens, Greece.
  • Turner DB; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Centre for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD 20903, USA.
  • Griffin BT; Simulations Plus, Inc., Lancaster, CA 93534, USA.
  • Darwich A; Certara UK, Simcyp Division, Sheffield S1 2BJ, UK.
  • Dressman J; School of Pharmacy, University College Cork, T12 YT20 Cork, Ireland.
  • Mackie C; Division of Health Informatics and Logistics, KTH Royal Institute of Technology, SE-164 40 Stockholm, Sweden.
Pharmaceutics ; 14(5)2022 May 07.
Article em En | MEDLINE | ID: mdl-35631595

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Qualitative_research Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Qualitative_research Idioma: En Ano de publicação: 2022 Tipo de documento: Article