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5 produkter
Solid Oral Dose Process Validation, Volume Two
Lifecycle Approach Application
Av Ajay Pazhayattil, Naheed Sayeed-Desta m. fl.
Inbunden, 2019
962 kr
Lägg i varukorg
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 …
Solid Oral Dose Process Validation, Volume Two
Lifecycle Approach Application
Av Jordan Collins, Marzena Ingram m. fl.
E-bok, 2019
1211 kr
Lägg i varukorg
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 …
Technology Transfer
Drug Product Manufacturing Process
Av Ajay Babu Pazhayattil, Sanjay Sharma m. fl.
Inbunden, 2023
1580 kr
Lägg i varukorg
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 …
Technology Transfer
Drug Product Manufacturing Process
Av Marzena Ingram, Michelle Gischewski-Silva m. fl.
E-bok, 2023
1511 kr
Lägg i varukorg
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 …
Technology Transfer
Drug Product Manufacturing Process
Av Ajay Babu Pazhayattil, Sanjay Sharma m. fl.
Häftad, 2024
1128 kr
Lägg i varukorg
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 …