Analytical, Bioanalytical, Stability-Indicating Methods: Key Part of Regulatory Submissions

According to the International Conference for Harmonization (ICH), the validation and verification data must be included in the Electronic Common Technical Document. The validated analytical procedure gets automatically Food and drug approved (FDA) if it is part of New drug application (NDA), Abbrev...

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Autor principal:	Deshpande, Mahesh Mukund
Formato:	Capítulo de libro
Lenguaje:	inglés
Publicado:	IntechOpen 2020
Materias:	Physical Sciences, Engineering and Technology
Acceso en línea:	https://www.intechopen.com/chapters/73202
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