A Biopharmetrics Approach for Drug Product Quality Control with Clinical Relevance

Author:

Duan John Z.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference27 articles.

1. Increasing patient involvement in drug development;Lowe;Value Health,2016

2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of in Vitro/In Vivo Correlations,1997

3. Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era;Ferreira;Pharm Dev Technol,2015

4. Quality by design case study: an integrated multivariate approach to drug product and process development;Huang;Int J Pharm,2009

5. Data processing in multivariate analysis of pharmaceutical processes;Lopes,2018

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