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...
Guardado en:
| Autor principal: | |
|---|---|
| Formato: | Capítulo de libro |
| Lenguaje: | inglés |
| Publicado: |
IntechOpen
2020
|
| Materias: | |
| Acceso en línea: | https://www.intechopen.com/chapters/73202 |
| Etiquetas: |
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
Ejemplares similares: Analytical, Bioanalytical, Stability-Indicating Methods: Key Part of Regulatory Submissions
- Biomolecules Functionalized Carbon Nanotubes for Bioanalytical and Biomedical Applications
- Various Approaches to Fourier-Transform Infrared Spectroscopy (FTIR) for Bioanalytical and Biotechnological Applications in Marine Algae
- Pyrrole-Imidazole Polyamides for Gene Therapy: Bioanalytical Methods and Pharmacokinetics
- The Analytic Hierarchy and the Network Process in Multicriteria Decision Making: Performance Evaluation and Selecting Key Performance Indicators Based on ANP Model
- Combining Capability Indices and Control Charts in the Process and Analytical Method Control Strategy
- The Use of Non-Food Biomass for Biodiesel Production: Economic Opportunities and Regulatory Framework [Part 2]