Evaluation of Therapeutics for Severely Debilitating or Life‐Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development-Reference-Cited by-同舟云学术

Evaluation of Therapeutics for Severely Debilitating or Life‐Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development

Published:2019-11-22 Issue:3 Volume:107 Page:514-520
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Liu Maggie¹,Fields F. Owen²,Prescott Judith S.³,Bello Akintunde⁴,Bower Nancy⁵,Darakjy Salima⁶,Hartke James⁷,Kadambi Vivek⁸,Lapadula Daniel⁹,Stoch Aubrey¹⁰^ORCID,Derzi Mazin¹¹

Affiliation:

1. Drug Safety Research and Development Pfizer Inc La Jolla California USA

2. Worldwide Global Regulatory Affairs Collegeville Pennsylvania USA

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

4. Clinical Pharmacology and Pharmacometrics Bristol‐Myers Squibb Princeton New Jersey USA

5. Global Nonclinical Regulatory Eisai Inc. Woodcliff Lake New Jersey USA

6. Worldwide Medical and Safety Pfizer, Inc New York New York USA

7. Nonclinical Development Celgene La Jolla California USA

8. Quantitative Pharmacology & Drug Safety Evaluation Blueprint Medicines Cambridge Massachusetts USA

9. Preclinical Safety Novartis Institutes for Biomedical Research East Hanover New Jersey USA

10. Translational Pharmacology Merck & Co., Inc Kenilworth New Jersey USA

11. Drug Safety Research and Development Pfizer Inc Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1673

Reference25 articles.

1. Evaluation of Therapeutics for Advanced-Stage Heart Failure and Other Severely-Debilitating or Life-Threatening Diseases

2. US Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).Guidance for industry. Expedited programs for serious conditions — drugs and biologics (May2014).

3. US Food and Drug Administration.Fast track breakthrough therapy accelerated approval priority review. Accessed February 12 2017.

4. US Food and Drug Administration Center for Biologics Evaluation and Research (CBER).Draft guidance for industry. Expedited programs for regenerative medicine therapies for serious conditions (November 2017).

5. US Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER).Draft guidance for industry. Rare diseases: common issues in drug development (February2019).

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Endeavours made by trade associations, pharmaceutical companies and regulators in the replacement, reduction and refinement of animal experimentation in safety testing of pharmaceuticals;Regulatory Toxicology and Pharmacology;2024-09

2. Low-dimensional nanomaterials for antibacterial applications;Journal of Materials Chemistry B;2021

3. Nonclinical safety assessment of epigenetic modulatory drugs: Current status and industry perspective;Regulatory Toxicology and Pharmacology;2020-11

4. Are Regulators Talking to Each Other Across Borders?;Clinical Pharmacology & Therapeutics;2020-02-11