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Dissolution Testing in Drug Product Development: Workshop Summary Report.
Abend, Andreas; Curran, David; Kuiper, Jesse; Lu, Xujin; Li, Hanlin; Hermans, Andre; Kotwal, Pramod; Diaz, Dorys A; Cohen, Michael J; Zhang, Limin; Stippler, Erika; Drazer, German; Lin, Yiqing; Raines, Kimberly; Yu, Lawrence; Coutant, Carrie A; Grady, Haiyan; Krämer, Johannes; Pope-Miksinski, Sarah; Suarez-Sharp, Sandra.
Afiliação
  • Abend A; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA. andreas_abend@merck.com.
  • Curran D; Analytical Sciences and Development, GlaxoSmithKline, King of Prussia, Pennsylvania, 19406, USA.
  • Kuiper J; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
  • Lu X; Drug Product Science and Technology, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA.
  • Li H; Vertex Pharmaceuticals Inc., 50 Northern Ave., Boston, Massachusetts, 02210, USA.
  • Hermans A; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
  • Kotwal P; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
  • Diaz DA; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA.
  • Cohen MJ; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA.
  • Zhang L; Drug Product Science and Technology, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA.
  • Stippler E; United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA.
  • Drazer G; Department of Mechanical and Aerospace Engineering, Rutgers, The State University of New Jersey, New Brunswick, New Jersey, USA.
  • Lin Y; Analytical Development, Biogen Inc., Cambridge, Massachusetts, 02142, USA.
  • Raines K; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Yu L; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
  • Coutant CA; Small Molecule Design & Development, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana, 46285, USA.
  • Grady H; Takeda Pharmaceutical International, 35 Lansdowne Street, Cambridge, Massachusetts, 02139, USA.
  • Krämer J; Eurofins-PHAST GmbH, Kardinal-Wendel-Str. 16, 66424, Homburg, Saarland, Germany.
  • Pope-Miksinski S; AstraZeneca Pharmaceuticals, One MedImmune Way, Gaithersburg, Maryland, 20878, USA.
  • Suarez-Sharp S; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
AAPS J ; 21(2): 21, 2019 01 28.
Article em En | MEDLINE | ID: mdl-30690680
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Qualidade / Desenvolvimento de Medicamentos Tipo de estudo: Prognostic_studies Limite: Animals / Humans Idioma: En Ano de publicação: 2019 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Controle de Qualidade / Desenvolvimento de Medicamentos Tipo de estudo: Prognostic_studies Limite: Animals / Humans Idioma: En Ano de publicação: 2019 Tipo de documento: Article