Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review-Reference-Cited by-同舟云学术

Systematic Approaches on Extractable and Leachable Study Designs in Pharmaceuticals and Medical Devices: A Review

Published:2023-10 Issue:3 Volume:7 Page:127-145
ISSN:2520-1034
Container-title:Journal of Packaging Technology and Research
language:en
Short-container-title:J Package Technol Res

Author:

Sharma Nitish^ORCID,Brahmankar Yashada^ORCID,Babar Diksha^ORCID,Bhogle Tejas^ORCID,Mirase Ramdas^ORCID,Rathod Rajeshwari^ORCID,Shah Ravi^ORCID

Publisher

Springer Science and Business Media LLC

Subject

General Medicine

Link

https://link.springer.com/content/pdf/10.1007/s41783-023-00157-8.pdf

Reference75 articles.

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3. Bennett P, Specialist T (2017) Extractables and leachables testing a risk based approach. Readind Scientific Services Ltd (RSSL)

4. Broschard TH, Glowienke S, Bruen US et al (2016) Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics—current challenges and approaches. Regul Toxicol Pharmacol 81:201–211. https://doi.org/10.1016/j.yrtph.2016.08.011

5. Bush L (ed) (2020) Extractables and leachables testing for pharmaceutical packaging, products, and medical devices. In: Current trends in mass spectrometry, 12th edn. Wiley

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