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1. |
Record Nr. |
UNINA990008666810403321 |
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Autore |
Martini, Egidio <1919-2011> |
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Titolo |
La pittura del Settecento veneto / Egidio Martini |
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Pubbl/distr/stampa |
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Udine : Istituto per l'Enciclopedia del Friuli-Venezia Giulia, , 1982 |
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Descrizione fisica |
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Collana |
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Disciplina |
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Livello bibliografico |
Monografia |
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2. |
Record Nr. |
UNISA990003132480203316 |
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Autore |
VALLOTTON, Félix |
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Titolo |
Félix Vallotton / [testi di Piero Bianconi] |
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Pubbl/distr/stampa |
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Descrizione fisica |
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[8] p., XVI p. di tav. : ill. ; 36 cm |
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Collana |
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I maestri del colore ; 126 |
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Disciplina |
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Soggetti |
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Collocazione |
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V A 1 MC XXIII |
XII.2. Coll. 21/ 126 |
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Materiale a stampa |
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Livello bibliografico |
Monografia |
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3. |
Record Nr. |
UNINA9910349446003321 |
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Autore |
Pazhayattil Ajay |
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Titolo |
Solid Oral Dose Process Validation, Volume Two : Lifecycle Approach Application / / by Ajay Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Marzena Ingram, Jordan Collins |
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Pubbl/distr/stampa |
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Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
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ISBN |
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Edizione |
[1st ed. 2019.] |
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Descrizione fisica |
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1 online resource (116 pages) |
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Collana |
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AAPS Introductions in the Pharmaceutical Sciences, , 2522-834X |
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Disciplina |
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Soggetti |
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Pharmacology |
Pharmacy |
Pharmacology/Toxicology |
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Livello bibliografico |
Monografia |
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Nota di contenuto |
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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. |
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Sommario/riassunto |
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The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic |
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understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation. |
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