Pharmacology‐Guided Rule‐Based Adaptive Dose Escalation in First‐in‐Human Studies-Reference-Cited by-同舟云学术

Pharmacology‐Guided Rule‐Based Adaptive Dose Escalation in First‐in‐Human Studies

Published:2020-11-24 Issue:5 Volume:109 Page:1326-1333
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Hoogdalem Ewoud‐Jan¹,Iersel Mattheus (Thijs)¹,Winter Erica²,Constant John³,Kappler Martin⁴

Affiliation:

1. PRA Health Sciences Scientific Affairs – Clinical Pharmacology Groningen The Netherlands

2. Pfizer New York New York USA

3. PRA Health Sciences, Scientific Affairs Victoria British Columbia Canada

4. PRA Health Sciences Statistical Consulting Services Levallois‐Perret France

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2101

Reference43 articles.

1. European Medicines Agency.Strategies to identify and mitigate risks for first in human and early clinical trials with investigational medicinal products Revision 1 adopted guideline. EMEA/CHMP/SWP/28367/07 Rev. 1 (July 25 2017).

2. International Conference on Harmonisation.Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2) (June 11 2009).

3. Design and Conduct Considerations for First-in-Human Trials

4. US Food and Drug Administration.Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers (July2005).

5. US Food and Drug Administration.Guidance for industry: expansion cohorts: use in first‐in‐human clinical trials to expedite development of oncology drugs and biologics(August2018).