Model-Informed Drug Development: Steps Toward Harmonized Guidance

Affiliations

• ¹ Clinical Pharmacology Modelling and Simulation, GSK, Stevenage, UK.
• ² Clinical Pharmacology Modeling and Simulation, AMGEN, Thousand Oaks, California, USA.
• ³ Global PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
• ⁴ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
• ⁵ Global Clinical Operations, Teva, Zagreb, Croatia.
• ⁶ Nonclinical and Clinical R&D, Tecnimede SA, Lisbon, Portugal.
• ⁷ Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
• ⁸ International Regulatory Sciences & Policy, Pfizer, New York, New York, USA.
• ⁹ Clinical Research, Pfizer R&D Japan, Tokyo, Japan.
• ¹⁰ National Medical Products Administration, Beijing, China.
• ¹¹ Pharmacometrics, Bayer, Berlin, Germany.
• ¹² Federal Agency for Medicines and Health Products, Brussels, Belgium and University of Namur, Namur, Belgium.
• ¹³ European Medicines Agency, Amsterdam, The Netherlands.
• ¹⁴ Clinical & Quantitative Pharmacology, Vertex Pharmaceuticals, Boston, Massachusetts, USA.
• ¹⁵ Health Canada/Pharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.
• ¹⁶ Clinical Pharmacology, AbbVie, North Chicago, Illinois, USA.
• ¹⁷ U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, USA.
• ¹⁸ Center for Drug Evaluation (CDE), Taipei, Taiwan.
• ¹⁹ Center for Drug Evaluation, Taipei, Taiwan.
• ²⁰ Novartis Institutes for Biomedical Research Co., Shanghai, China.
• ²¹ Health Canada, Biologic and Radiopharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.
• ²² US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
• ²³ Swedish Medical Products Agency, Uppsala, Sweden.