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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
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
Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
Journal of Pharmaceutical Analysis, 2021Zhaopeng Yang
exaly
GENERAL PARAMETERS OF MONOGRAPHS FOR HERBAL DRUGS AND COMPARATIVE STUDY OF PHARMACOPOEIA
2020openaire +1 more source
The Ayurvedic Pharmacopoeia of India, development and perspectives
Journal of Ethnopharmacology, 2017Vinod Kumar Joshi, Apurva Joshi
exaly

