Review, Early Access, 2024

Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program

CLINICAL PHARMACOLOGY & THERAPEUTICS, ISSN 0009-9236, 10.1002/cpt.3245

Contributors

Galluppi, Gerald R. [1] [2] Ahamadi, Malidi [3] [4] Bhattacharya, Souvik [5] Budha, Nageshwar [6] Gheyas, Ferdous [7] Li, Chi-Chung [8] [9] Chen, Yuan [8] [9] Dosne, Anne-Gaelle [10] Kristensen, Niels Rode [11] Magee, Mindy [12] Samtani, Mahesh N. [10] Sinha, Vikram [13] Taskar, Kunal [12] Upreti, Vijay V. [14] Yang, Jianning [5] Cook, Jack (Corresponding author) [15]

Affiliations

  1. [1] Sunovion Pharmaceut Inc, US Subsidiary Sumitomo Pharma Amer, Marlborough, MA USA
  2. [NORA names: United States; America, North; OECD];
  3. [2] Sunovion Pharmaceut Inc, US Subsidiary Sumitomo Pharma Amer, Marlborough, MA USA
  4. [NORA names: United States; America, North; OECD];
  5. [3] Sanofi, Paris, France
  6. [NORA names: France; Europe, EU; OECD];
  7. [4] Sanofi, Paris, France
  8. [NORA names: France; Europe, EU; OECD];
  9. [5] Astellas Pharma Inc, Chuo City, Japan
  10. [NORA names: Japan; Asia, East; OECD];

Abstract

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Data Provider: Clarivate