Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Pfahler, Lori B.; Burdick, Richard K.; Quiroz, Jorge; LeBlond, David J.; Sidor, Leslie; Zhang, Lanju; Vukovinsky, Kimberly
Springer International Publishing AG
02/2017
379
Dura
Inglês
9783319501840
15 a 20 dias
7096
Descrição não disponível.
Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Analytical Methods;Biosimilarity;CMC Statistics;Chemistry, Manufacturing and Controls;FDA Guidance;Pharmaceutical Manufacturing;Process Verification;Quality by Design;Stability Studies
Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
