Solid Oral Dose Process Validation [[electronic resource] ] : The Basics, Volume 1 / / by Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins |
Autore | Pazhayattil Ajay Babu |
Edizione | [1st ed. 2018.] |
Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2018 |
Descrizione fisica | 1 online resource (99 pages) |
Disciplina | 615.19 |
Collana | AAPS Introductions in the Pharmaceutical Sciences |
Soggetto topico |
Pharmaceutical technology
Pharmacy Pharmaceutical Sciences/Technology |
ISBN | 3-030-02472-5 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Volume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification. |
Record Nr. | UNINA-9910298400003321 |
Pazhayattil Ajay Babu | ||
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2018 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Technology Transfer [[electronic resource] ] : 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 |
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 |
Pazhayattil Ajay Babu | ||
Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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