Ajay Babu Pazhayattil – författare
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9 produkter
Solid Oral Dose Process Validation
The Basics, Volume 1
Av Ajay Babu Pazhayattil, Naheed Sayeed-Desta m. fl.
Inbunden, 2018
1128 kr
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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 …
Solid Oral Dose Process Validation
The Basics, Volume 1
Av Jordan Collins, Emilija Fredro-Kumbaradzi m. fl.
E-bok, 2018
1470 kr
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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 …
Technology Transfer
Drug Product Manufacturing Process
Av Ajay Babu Pazhayattil, Sanjay Sharma m. fl.
Inbunden, 2023
1580 kr
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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
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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
2023
686 kr
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Technology Transfer
Drug Product Manufacturing Process
Av Ajay Babu Pazhayattil, Sanjay Sharma m. fl.
Häftad, 2024
1128 kr
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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 …
Pharmaceutical Manufacturing Deviation and Failure Investigations
Principles, Practices, and Case Studies
Av Ajay Babu Pazhayattil, Sanjay Sharma
Inbunden, 2025
1125 kr
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This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a …
Pharmaceutical Manufacturing Deviation and Failure Investigations
Principles, Practices, and Case Studies
Av Sanjay Sharma, Ajay Babu Pazhayattil
E-bok, 2025
1470 kr
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This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a …
Pharmaceutical Manufacturing Deviation and Failure Investigations
Principles, Practices, and Case Studies
Av Ajay Babu Pazhayattil, Sanjay Sharma
Häftad, 2026
792 kr
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This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a …
