Results 111 to 120 of about 1,606 (135)

Efficiency of Lifecycle Management for Medicinal Products in the EU: Industry Experience with Variations to Implement a New European Pharmacopoeia Active Substance Monograph for a Generic Eye Drops Solution – A Case Study

Therapeutic Innovation & Regulatory Science
While numerous efforts were taken by the regulators globally to have more streamlined and predictable post-approval CMC variation procedures, there are still areas where cumbersome and parallel assessments of variations may delay implementation of important CMC changes and bind resources in industry and regulatory authorities.In this case study a ...
Fabian P, Schwarb   +2 more
openaire   +2 more sources

The Ayurvedic Pharmacopoeia of India, development and perspectives

Journal of Ethnopharmacology, 2017
Vinod Kumar Joshi, Apurva Joshi
exaly  

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