Model‐Informed Drug Development: Steps Toward Harmonized Guidance

Author:

Marshall Scott1,Ahamadi Malidi2,Chien Jenny3,Iwata Daisuke4,Farkas Pavel5,Filipe Augusto6,Frey Nicolas7,Greene Erin8,Kawai Norisuke9,Li Jian10,Lippert Jörg11ORCID,Musuamba Tshinanu Flora12ORCID,Manolis Efthymios13,Peterson Mark C.14,Sarem Sarem15,Shebley Mohamad16ORCID,Tegenge Million17,Tsai Chia‐Hsun18,Tu Chien‐Lung19,Otsubo Yasuto4,Wei Jiawei20,Zhang Lucia21,Zhu Hao22,Karlsson Kristin E.23

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference11 articles.

1. Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

2. Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases

3. US Food and Drug AdministrationFDA‐ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products(2018) Accessed 04 April 2023.

4. Role of model‐informed drug development in pediatric drug development, regulatory evaluation, and labeling;Bi Y.;J. Clin. Pharmacol.,2019

5. Opportunities and challenges for applying model‐informed drug development approaches to gene therapies

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