Risk-Based Predictive Stability for Pharmaceutical Development-A Proposed Regulatory Template: 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

Risk-Based Predictive Stability for Pharmaceutical Development-A Proposed Regulatory Template: 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

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Veröffentlicht in:Pharmaceutical technology Europe 2018-08, Vol.30 (8), p.32
Hauptverfasser: Stephens, Dennis, Williams, Helen, McMahon, Megan, Qiu, Fenghe, Hyzer, Cherokee Hoaglund, Debie, Elke, Wu, Yan, Li, Hanlin, Wang, Jin
Format: Artikel
Sprache:eng
Schlagworte:
Backup software
Best practices
Drug monitoring
Inspection
Methods
Pharmaceutical industry
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ISSN:1753-7967