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Accelerated predictive stability : fundamentals and pharmaceutical industry practices / / edited by Fenghe Qiu, Garry Scrivens
| Accelerated predictive stability : fundamentals and pharmaceutical industry practices / / edited by Fenghe Qiu, Garry Scrivens |
| Autore | Qiu Fenghe |
| Pubbl/distr/stampa | San Diego, California : , : Elsevier, , 2018 |
| Descrizione fisica | 1 online resource (514 pages) |
| Disciplina | 615.18 |
| Soggetto topico |
Drug stability
Pharmaceutical industry |
| ISBN |
0-12-802785-1
0-12-802786-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I. General chapters -- Accelerated predictive stability: an introduction -- Regulatory expectations and industry practice on stability testing -- Theory and fundamentals of accelerated predictive stability (APS) studies -- Practical considerations -- The humidity exposure of packaged products -- Data evaluation and statistical methods -- Strategies for improving the reliability of accelerated predictive stability (APS) studies -- Integration of APS into a rapid, early clinical drug product development paradigm -- Accelerated predictive stability (APS) regulatory strategies -- Embedding APS within business -- Implementing an accelerated predictive stability program -- Part II. Industry practices -- Accelerated stability assessment program (ASAP) applications in a postapproval environment -- ASAP application: unstable drug candidate in early development -- ASAP application in suspension, liquid, lyophilized, and controlled-release drug products -- Applications of ASAP to generic drugs -- ASAP application: nicotine lozenges -- ASAP applications in clinical development: prediction of degradation and dissolution performance -- Accelerated predictive stability (APS) applications: packaging strategies for controlling dissolution performance -- Accelerated stability modeling: investigation of disintegration time of a drug product with sodium bicarbonate -- Accelerated stability modeling: an ionic liquid drug product -- Accelerated stability modeling: assay loss of nicotine lozenges -- Accelerated stability modeling: desolvation of a solvate drug product. |
| Record Nr. | UNINA-9910583498903321 |
Qiu Fenghe
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| San Diego, California : , : Elsevier, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drugs [[electronic resource] ] : photochemistry and photostability / / edited by A. Albini, E. Fasani
| Drugs [[electronic resource] ] : photochemistry and photostability / / edited by A. Albini, E. Fasani |
| Pubbl/distr/stampa | Cambridge, : Royal Society of Chemistry, 1998 |
| Descrizione fisica | 1 online resource (336 p.) |
| Disciplina | 615.18 |
| Altri autori (Persone) |
AlbiniA
FasaniE |
| Collana | Special publication |
| Soggetto topico |
Drug stability
Photochemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-84755-071-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | BK9780854047437-FX001; BK9780854047437-FP001; BK9780854047437-FP005; BK9780854047437-FP007; BK9780854047437-00001; BK9780854047437-00074; BK9780854047437-00087; BK9780854047437-00100; BK9780854047437-00116; BK9780854047437-00134; BK9780854047437-00150; BK9780854047437-00162; BK9780854047437-00171; BK9780854047437-00182; BK9780854047437-00194; BK9780854047437-00211; BK9780854047437-00227; BK9780854047437-00243; BK9780854047437-00247; BK9780854047437-00272; BK9780854047437-00288; BK9780854047437-00295; BK9780854047437-00305; BK9780854047437-00317 |
| Record Nr. | UNINA-9910455147103321 |
| Cambridge, : Royal Society of Chemistry, 1998 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drugs, photochemistry and photostability / / editors, A. Albini, E. Fasani
| Drugs, photochemistry and photostability / / editors, A. Albini, E. Fasani |
| Pubbl/distr/stampa | Cambridge : , : Royal Society of Chemistry, , 1998 |
| Descrizione fisica | 1 online resource (viii, 326 pages) : illustrations |
| Disciplina | 615.18 |
| Altri autori (Persone) |
AlbiniAngelo
FasaniE (Elisa) |
| Collana | Special publication |
| Soggetto topico |
Drug stability
Photochemistry |
| ISBN | 1-84755-071-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778320003321 |
| Cambridge : , : Royal Society of Chemistry, , 1998 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drugs, photochemistry and photostability / / editors, A. Albini, E. Fasani
| Drugs, photochemistry and photostability / / editors, A. Albini, E. Fasani |
| Pubbl/distr/stampa | Cambridge : , : Royal Society of Chemistry, , 1998 |
| Descrizione fisica | 1 online resource (viii, 326 pages) : illustrations |
| Disciplina | 615.18 |
| Altri autori (Persone) |
AlbiniAngelo
FasaniE (Elisa) |
| Collana | Special publication |
| Soggetto topico |
Drug stability
Photochemistry |
| ISBN | 1-84755-071-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910811641803321 |
| Cambridge : , : Royal Society of Chemistry, , 1998 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Freeze-drying of pharmaceuticals and biopharmaceuticals [[electronic resource] ] : [principles and practice] / / Felix Franks ; in association with Tony Auffret
| Freeze-drying of pharmaceuticals and biopharmaceuticals [[electronic resource] ] : [principles and practice] / / Felix Franks ; in association with Tony Auffret |
| Autore | Franks Felix |
| Pubbl/distr/stampa | Cambridge, : RSC Publishing, c2007 |
| Descrizione fisica | 1 online resource (219 p.) |
| Disciplina | 615.18 |
| Altri autori (Persone) | AuffretTony |
| Soggetto topico |
Frozen drugs
Freeze-drying Biopharmaceutics |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-84755-770-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Freeze-drying of Pharmaceuticals and Biopharmaceuticals_publicity; i_iv; v_viii; ix_xii; 001_012; 013_019; 020_027; 028_053; 054_077; 078_088; 089_104; 105_120; 121_129; 130_140; 141_170; 171_181; 182_186; 187_189; 190_200; 201_206 |
| Record Nr. | UNINA-9910462209703321 |
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Franks Felix
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| Cambridge, : RSC Publishing, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Freeze-drying of pharmaceuticals and biopharmaceuticals : [principles and practice] / / Felix Franks ; in association with Tony Auffret
| Freeze-drying of pharmaceuticals and biopharmaceuticals : [principles and practice] / / Felix Franks ; in association with Tony Auffret |
| Autore | Franks Felix |
| Pubbl/distr/stampa | Cambridge : , : RSC Publishing, , 2007 |
| Descrizione fisica | 1 online resource (xii, 206 pages) : illustrations |
| Disciplina | 615.18 |
| Altri autori (Persone) | AuffretTony |
| Soggetto topico |
Frozen drugs
Freeze-drying Biopharmaceutics |
| ISBN | 1-84755-770-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910786355203321 |
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Franks Felix
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| Cambridge : , : RSC Publishing, , 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Freeze-drying of pharmaceuticals and biopharmaceuticals : [principles and practice] / / Felix Franks ; in association with Tony Auffret
| Freeze-drying of pharmaceuticals and biopharmaceuticals : [principles and practice] / / Felix Franks ; in association with Tony Auffret |
| Autore | Franks Felix |
| Pubbl/distr/stampa | Cambridge : , : RSC Publishing, , 2007 |
| Descrizione fisica | 1 online resource (xii, 206 pages) : illustrations |
| Disciplina | 615.18 |
| Altri autori (Persone) | AuffretTony |
| Soggetto topico |
Frozen drugs
Freeze-drying Biopharmaceutics |
| ISBN | 1-84755-770-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910813400103321 |
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Franks Felix
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| Cambridge : , : RSC Publishing, , 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Packaging technology and engineering : pharmaceutical, medical and food applications / / Dipak Kumar Sarker
| Packaging technology and engineering : pharmaceutical, medical and food applications / / Dipak Kumar Sarker |
| Autore | Sarker Dipak K. |
| Pubbl/distr/stampa | Hoboken, New Jersey ; ; West Sussex, England : , : Wiley, , [2020] |
| Descrizione fisica | 1 online resource (519 pages) |
| Disciplina | 615.18 |
| Soggetto topico | Drugs - Packaging - Quality control |
| ISBN |
1-5231-4400-9
1-119-21390-8 1-119-21389-4 1-119-21395-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Historical perspective and evolution -- Chemical engineering of packaging materials -- Material science and chemistry -- The physics of packaging materials -- Engineering product : design, formation and machining -- Packaging for various applications -- Food, pharmaceutical and medical packaging -- Suppliers and manufacturers of packaging -- Problems : questions, calculations, estimates and dilemmas. |
| Record Nr. | UNINA-9910555172303321 |
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Sarker Dipak K.
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| Hoboken, New Jersey ; ; West Sussex, England : , : Wiley, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Packaging technology and engineering : pharmaceutical, medical and food applications / / Dipak Kumar Sarker
| Packaging technology and engineering : pharmaceutical, medical and food applications / / Dipak Kumar Sarker |
| Autore | Sarker Dipak K. |
| Pubbl/distr/stampa | Hoboken, New Jersey ; ; West Sussex, England : , : Wiley, , [2020] |
| Descrizione fisica | 1 online resource (519 pages) |
| Disciplina | 615.18 |
| Soggetto topico | Drugs - Packaging - Quality control |
| ISBN |
1-5231-4400-9
1-119-21390-8 1-119-21389-4 1-119-21395-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Historical perspective and evolution -- Chemical engineering of packaging materials -- Material science and chemistry -- The physics of packaging materials -- Engineering product : design, formation and machining -- Packaging for various applications -- Food, pharmaceutical and medical packaging -- Suppliers and manufacturers of packaging -- Problems : questions, calculations, estimates and dilemmas. |
| Record Nr. | UNINA-9910828155503321 |
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Sarker Dipak K.
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| Hoboken, New Jersey ; ; West Sussex, England : , : Wiley, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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