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Solid Oral Dose Process Validation, Volume Two : Lifecycle Approach Application / / by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins
| Solid Oral Dose Process Validation, Volume Two : Lifecycle Approach Application / / by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins |
| Autore | Pazhayattil Ajay |
| Edizione | [1st ed. 2019.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
| Descrizione fisica | 1 online resource (116 pages) |
| Disciplina | 615.19 |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmacology
Pharmacy Pharmacology/Toxicology |
| ISBN | 3-030-27484-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies -- Chapter 2: Stage 1 Scale Up, Tech Transfer Process -- Considerations for process scale up and transfer -- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan -- PPQ batch determination method, scientifically supported sampling and testing plans -- Chapter 4: Stage 3A Continued Process Verification -- Stage 3A assessment methodology for newly launched products -- Chapter 5: Stage 3B Continued Process Verification -- Routine CPV monitoring plan for commercial products. |
| Record Nr. | UNINA-9910349446003321 |
Pazhayattil Ajay
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Technology Transfer : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
| Technology Transfer : Drug Product Manufacturing Process / / by Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram |
| Autore | Pazhayattil Ajay Babu |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (158 pages) |
| Disciplina |
615.1
615.19 |
| Altri autori (Persone) |
SharmaSanjay
PhilipJoe Paul Gischewski-SilvaMichelle IngramMarzena |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmacy
Pharmaceutical chemistry Pharmacology Drug delivery systems Pharmacovigilance Pharmaceutics Drug Delivery Drug Safety and Pharmacovigilance |
| ISBN | 3-031-32192-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products. |
| Record Nr. | UNINA-9910731465203321 |
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Pazhayattil Ajay Babu
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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