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A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.
Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U.
Affiliation
  • Martin-Moe S; Late Stage Pharmaceutical and Processing Development, Genentech Inc., South San Francisco, California 94080; Biologics Pharmaceutical Development, Novartis Pharma AG, CH-4002 Basel, Switzerland. Electronic address: sheryl.martin-moe@novartis.com.
  • Lim FJ; Late Stage Pharmaceutical and Processing Development, Genentech Inc., South San Francisco, California 94080.
  • Wong RL; Late Stage Pharmaceutical and Processing Development, Genentech Inc., South San Francisco, California 94080.
  • Sreedhara A; Late Stage Pharmaceutical and Processing Development, Genentech Inc., South San Francisco, California 94080.
  • Sundaram J; Biologics MSAT, Genentech Inc., South San Francisco, California 94080.
  • Sane SU; Biologics MSAT, Genentech Inc., South San Francisco, California 94080.
J Pharm Sci ; 100(8): 3031-3043, 2011 Aug.
Article in En | MEDLINE | ID: mdl-21425164
Subject(s)
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Pharmaceutical Preparations / Technology, Pharmaceutical / Drug Discovery Type of study: Etiology_studies / Guideline / Risk_factors_studies Language: En Journal: J Pharm Sci Year: 2011 Document type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Pharmaceutical Preparations / Technology, Pharmaceutical / Drug Discovery Type of study: Etiology_studies / Guideline / Risk_factors_studies Language: En Journal: J Pharm Sci Year: 2011 Document type: Article