The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes-Reference-Cited by-同舟云学术

The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes

Published:2021-07-08 Issue:6 Volume:110 Page:1512-1525
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Cherkaoui Sanae¹,Pinnow Ellen¹,Bulatao Ilynn¹,Day Brendan²,Kalaria Manish¹,Brajovic Sonja¹,Dal Pan Gerald¹

Affiliation:

1. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. University of Maryland School of MedicineUniversity of Maryland Baltimore Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2320

Reference20 articles.

1. Code of Federal Regulations.§21‐314.126. Title 21 Chapter I subchapter D‐‐drugs for human use. PART 314 ‐‐ Applications for FDA approval to market a new drug. Subpart D‐‐FDA Action on Applications and Abbreviated Applications. Department of Health and Human Services Editor.

2. International Conference on Harmonisation (ICH).The extent of population exposure to assess clinical safety: for drugs intended for long‐term treatment of non‐life‐threatening conditions (ICH E1). Accessed May 4 2021.

3. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

4. Clinical trial safety population size: analysis of drug approvals for rare and common indications by FDA Center for Drug Evaluation and Research

5. Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?

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