A naïve pooled data approach for extrapolation of Phase 0 microdose trials to therapeutic dosing regimens-Reference-Cited by-同舟云学术

A naïve pooled data approach for extrapolation of Phase 0 microdose trials to therapeutic dosing regimens

Published:2022-11-23 Issue:2 Volume:16 Page:258-268
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical Translational Sci

Author:

van der Heijden Lisa¹²^ORCID,van Nuland Merel¹²,Beijnen Jos¹²³,Huitema Alwin¹²⁴⁵,Dorlo Thomas¹²^ORCID

Affiliation:

1. Department of Pharmacy & Pharmacology Antoni van Leeuwenhoek/The Netherlands Cancer Institute Amsterdam The Netherlands

2. Division of Pharmacology Antoni van Leeuwenhoek/The Netherlands Cancer Institute Amsterdam The Netherlands

3. Division of Pharmaco‐epidemiology and Clinical Pharmacology, Faculty of Science, Department of Pharmaceutical Sciences Utrecht University Utrecht The Netherlands

4. Department of Clinical Pharmacy University Medical Center Utrecht, Utrecht University Utrecht The Netherlands

5. Department of Pharmacology Princess Máxima Center for Pediatric Oncology Utrecht The Netherlands

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13446

Reference28 articles.

1. Big physics, small doses: the use of AMS and PET in human microdosing of development drugs

2. European Medicines Agency (EMA).Position paper on non‐clinical safety studies to support clinical trials with a single microdose. Accessed April 2020.

3. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies

4. European Medicines Agency (EMA).ICH M3 (R2): Note for guidance on non‐clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Accessed April 2020.

5. Commentary

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