LIBROS DEL AUTOR: emilija fredro kumbaradzi

2 resultados para LIBROS DEL AUTOR: emilija fredro kumbaradzi

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  • Solid Oral Dose Process Validation, Volume Two
    Ajay Pazhayattil / Emilija Fredro-Kumbaradzi / Naheed Sayeed-Desta
    The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validatio...
    Disponible

    109,75 €

  • Solid Oral Dose Process Validation
    Ajay Babu Pazhayattil / Emilija Fredro-Kumbaradzi / Naheed Sayeed-Desta
    Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance’s such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance’s and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exi...
    Disponible

    122,00 €