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Solid Oral Dose Process Validation : The Basics, Volume 1 / / by Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins
| Solid Oral Dose Process Validation : 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
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 |
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Pazhayattil Ajay
|
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||