Statistical considerations for design and analysis of stability, comparability and formulation tests-Reference-Cited by-同舟云学术

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Statistical considerations for design and analysis of stability, comparability and formulation tests

Published:2022-10-24 Issue:2 Volume:22 Page:248-265
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Coleman Daniel¹,Pourmohamad Tony¹^ORCID

Affiliation:

1. Nonclinical Biostatistics Genentech South San Francisco California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2269

Reference18 articles.

1. ICH Q1E.Guidance for industry: Q1E Evaluation for stability data. Technical report U.S. Department of Health and Human Services FDA. Center of Drug Evaluation and Research (CDER) Rockville MD;2004.

2. ICH Q5E(R2).Guidance for industry: Q5E(R2) comparability of biotechnological/ biological products subject to changes in their manufacturing process. Technical report U.S. Department of Health and Human Services FDA. Center of Drug Evaluation and Research (CDER) Rockville MD;2005.

3. ICH Q8(R2).Guidance for industry: Q8 (R2) Pharmaceutical development. Technical report U.S. Department of Health and Human Services FDA. Center of Drug Evaluation and Research (CDER) Rockville MD;2009.

4. Statistical Considerations for Stability and the Estimation of Shelf Life

5. Estimating Shelf Life Through Tolerance Intervals

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