Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey-Reference-Cited by-同舟云学术

Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey

Published:2024-09-04 Issue: Volume: Page:
ISSN:0724-8741
Container-title:Pharmaceutical Research
language:en
Short-container-title:Pharm Res

Author:

Miesle James E.^ORCID,Osei-Yeboah Frederick,Pauli-Bruns Anette,Chen Bei,Manceva Slobodanka,Wade Jonathan B.,Yin Shawn,Desai Divyakant,Dirat Olivier,Bhugra Chandan,Stauffer Fanny

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s11095-024-03765-4.pdf

Reference29 articles.

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2. Debevec V, Srcic S, Horvat M. Scientific, statistical, practical, and regulatory considerations in design space development. Drug Dev Ind Pharm. 2018;44(3):349–64.

3. Thomson NM, Seibert KD, Tummala S, Bordawekar S, Kiesman WF, Irdam EA, Phenix B, Kumke D. Case studies in the applicability of drug substance design spaces developed on the laboratory scale to commercial manufacturing. Org Process Res Dev. 2015;19(8):925–34.

4. Watson TJN, Nosal R, Lepore J, Montgomery F. Misunderstanding Design Space: a Robust Drug Product Control Strategy Is the Key to Quality Assurance. J Pharm Innov. 2018;13(3):283–5.

5. ICH. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q12, Technical and Regulatory Considerations for Pharmaceutical Product lifecycle Management. 2024. Available from: https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf. Accessed 25 Jan 2024.