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A comprehensive study on regulatory requirements for development and filing of generic drugs globally

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be es...

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Detalhes bibliográficos
Main Authors: Handoo, Shweta, Arora, Vandana, Khera, Deepak, Nandi, Prafulla Kumar, Sahu, Susanta Kumar
Formato: Artigo
Idioma:Inglês
Publicado em: Medknow Publications & Media Pvt Ltd 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3555014/
https://ncbi.nlm.nih.gov/pubmed/23373001
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4103/2230-973X.104392
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