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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Medknow Publications & Media Pvt Ltd
2012
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/ https://www.ncbi.nlm.nih.gov/pubmed/23373001 http://dx.doi.org/10.4103/2230-973X.104392 |