QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters-Reference-Cited by-同舟云学术

QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters

Published:2024-03-25 Issue:4 Volume:28 Page:
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Rege Pankaj D.¹^ORCID,Schuster Andreas¹,Lamerz Jens²,Moessner Christian¹,Göhring Wolfgang¹,Hidber Pirmin³,Stahr Helmut¹,Andrei Oana Mihaela²,Burren Janine²,Moesching Alexandre²^ORCID,Coleman Daniel⁴,Hildbrand Stefan¹

Affiliation:

1. Process Chemistry & Catalysis, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel 4070, Switzerland

2. Nonclinical Biostatistics, F. Hoffmann-La Roche Ltd, Basel 4070, Switzerland

3. Solid State Sciences, Synthetic Molecules Technical Development, F. Hoffmann-La Roche Ltd, Basel 4070, Switzerland

4. Nonclinical Biostatistics, Genentech, Inc., South San Francisco, California 94080, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.3c00356

Reference25 articles.

1. a Pharmaceutical Development Q8(R2); International Conference on Harmonization (ICH).

2. b Quality Risk Management Q9(R1); International Conference on Harmonization (ICH).

3. c Pharmaceutical Quality System Q10; International Conference on Harmonization (ICH).

4. a Development and Manufacture of Drug Substance (Chemical Entities and Biotechnological/Biological Entities) Q11; International Conference on Harmonization (ICH).

5. b Development and Manufacture of Drug Substance (Chemical Entities and Biotechnological/Biological Entities) Q11 Q&A, 2017.

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