Strategies and Recommendations for Using a Data‐Driven and Risk‐Based Approach in the Selection of First‐in‐Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment-Reference-Cited by-同舟云学术

Strategies and Recommendations for Using a Data‐Driven and Risk‐Based Approach in the Selection of First‐in‐Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment

Published:2020-11-03 Issue:6 Volume:109 Page:1395-1416
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Leach Michael W.¹,Clarke David O.²,Dudal Sherri³,Han Chao⁴,Li Chunze⁵,Yang Zheng⁶,Brennan Frank R.⁷,Bailey Wendy J.⁸,Chen Yingxue⁹,Deslandes Antoine¹⁰,Loberg Lise I.¹¹,Mayawala Kapil¹²,Rogge Mark C.¹³,Todd Marque¹⁴,Chemuturi Nagendra V.¹⁵

Affiliation:

1. Drug Safety Research and Development Pfizer, Inc. Cambridge Massachusetts USA

2. Nonclinical Safety Assessment Eli Lilly and CompanyLilly Corporate Center Indianapolis Indiana USA

3. DMPK Project Leads and Translational M&S, Pharmaceutical Sciences F. Hoffmann‐La Roche Ltd. Basel Switzerland

4. Biologics Development Sciences Janssen Research and Development, LLC Spring House Pennsylvania USA

5. Department of Clinical Pharmacology Genentech, Inc. South San Francisco California USA

6. Metabolism and Pharmacokinetics Bristol‐Myers Squibb Co. Princeton New Jersey USA

7. Non‐Clinical Safety UCB Pharma Slough UK

8. Safety Assessment and Laboratory Animal Resources Merck & Co., Inc. West Point Pennsylvania USA

9. Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology and Safety Sciences BioPharmaceuticals R&D AstraZeneca Boston Massachusetts USA

10. Translational Medicine & Early Development Sanofi R&D, Centre de Recherche Vitry‐sur‐Seine 13 Vitry‐sur‐Seine Cedex France

11. Preclinical Safety AbbVie North Chicago Illinois USA

12. Quantitative Pharmacology and Pharmacometrics PPDM Merck & Co., Inc. Kenilworth New Jersey USA

13. Quantitative and Translational Science Takeda Pharmaceuticals Cambridge Massachusetts USA

14. Drug Safety Research and Development Pfizer, Inc. San Diego California USA

15. Pharmacokinetic Sciences Novartis Institute of BioMedical Research, Inc. Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2009

Reference35 articles.

1. US Food and Drug Administration (FDA). Guidance for Industry.Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. (July2005).

2. Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412

3. Toward experimental assessment of receptor occupancy: TGN1412 revisited

4. Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells

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