An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics-Reference-Cited by-同舟云学术

An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics

Published:2021-02 Issue:2 Volume:110 Page:610-614
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Besheer Ahmed,Burton Lori,Galas Richard J.,Gokhale Kedar,Goldbach Pierre,Hu Qingyan,Mathews Ligi,Muthurania Kevin,Narasimhan Chakravarthy,Singh Shubhadra N.,Stokes Elaine S.E.,Weiser Sarah,Zamiri Camellia,Zhou Shuxia

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference19 articles.

1. United States Pharmacopeia. USP General Chapter <800>, Hazardous Drugs – Handling in Healthcare Settings. USP42-NF37 Ed.

2. Overcoming challenges of implementing closed system transfer device clinical in-use compatibility testing for drug development of antibody drug conjugates;Petoskey;J Pharm Sci,2020

3. Challenges of using closed system transfer devices with biological drug products: an industry perspective;Alavattam;J Pharm Sci,2020

4. Evaluation of different quality-relevant aspects of closed system transfer devices (CSTDs);Besheer;Pharm Res,2020

5. A case study to address a gap in the device-to-vial interface stopper push-in by chemo spikes;Zhao;PDA J Pharm Sci Technol,2019

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2. Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands;The AAPS Journal;2024-05-15

3. Roadmap for Drug Product Development and Manufacturing of Biologics;Journal of Pharmaceutical Sciences;2024-02

4. Industry perspective on a holistic container closure integrity approach to parenteral combination products;European Journal of Pharmaceutics and Biopharmaceutics;2024-01

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