A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Yan Wu
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Yan Wu is principal scientist at Merck & Co., Inc.
Articles by Yan Wu
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplatePublished: August 2nd 2018 | Updated:
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