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.
Jin Wang
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Jin Wang is manager in manufacturing sciences, product supply biotech at Bayer HealthCare
Articles by Jin Wang
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplatePublished: August 2nd 2018 | Updated:
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