LIBROS DEL AUTOR: ajay pazhayattil

4 resultados para LIBROS DEL AUTOR: ajay pazhayattil

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  • Technology Transfer
    Ajay Babu Pazhayattil / Joe Paul Philip / Sanjay Sharma
    Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for...
    Disponible

    134,49 €

  • Technology Transfer
    Ajay Babu Pazhayattil / Joe Paul Philip / Sanjay Sharma
    Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for...
    Disponible

    48,45 €

  • 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 €