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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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ASHP injectable drug information : a comprehensive guide to compatibility and stability / / American Society of Health-System Pharmacists
| ASHP injectable drug information : a comprehensive guide to compatibility and stability / / American Society of Health-System Pharmacists |
| Pubbl/distr/stampa | [Place of publication not identified] : , : American Society of Health-System Pharmacists, , 2021 |
| Descrizione fisica | 1 online resource (1,756 pages) |
| Disciplina | 615 |
| Soggetto topico |
Incompatibles (Pharmacy)
Drug stability Injections |
| ISBN |
9781585286584
9781585286850 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910794432003321 |
| [Place of publication not identified] : , : American Society of Health-System Pharmacists, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
ASHP injectable drug information : a comprehensive guide to compatibility and stability / / American Society of Health-System Pharmacists
| ASHP injectable drug information : a comprehensive guide to compatibility and stability / / American Society of Health-System Pharmacists |
| Pubbl/distr/stampa | [Place of publication not identified] : , : American Society of Health-System Pharmacists, , 2021 |
| Descrizione fisica | 1 online resource (1,756 pages) |
| Disciplina | 615 |
| Soggetto topico |
Incompatibles (Pharmacy)
Drug stability Injections |
| ISBN |
9781585286584
9781585286850 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910815639103321 |
| [Place of publication not identified] : , : American Society of Health-System Pharmacists, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of vaccines [[electronic resource] ] : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava
| Development of vaccines [[electronic resource] ] : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina | 615/.372 |
| Altri autori (Persone) |
Manmohan Singh <1964 November 8->
SrivastaIndresh K |
| Soggetto topico |
Vaccines
Drug development Drug stability |
| ISBN |
1-283-17565-7
9786613175656 1-118-02363-3 1-118-02364-1 1-118-02362-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Microbial vaccines design : the reverse vaccinology approach / Roberto Rosini, Michele A. Barocchi, Rino Rappuoli -- Design and development of recombinant vaccines with viral properties / Gerd Lipowsky, Martin F. Bachmann -- Tools for vaccine design : prediction and validation of highly immunogenic and conserved class II epitopes, and development of epitope-driven vaccines / Anne S. De Groot ... [et al.] -- Virus like-particle vaccines advantages and challenges / Ted M. Ross ... [et al.] -- Design platforms of nanocapsules for human therapeutics or vaccines / Masaaki Kawano ... [et al.] -- Designing immunogens for vaccine development in reference to HIV / Aemro Kassa ... [et al.] --
Expression and purification of recombinant proteins for vaccine applications / Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava -- DNA vaccines for infectious diesase / Samuel Stepenson, Manmohan Singh, Indresh K. Srivastava -- Developing stable cell lines for the production of vaccine antigens / Xiaotian Zhong ... [et al.] -- Spectroscopy of vaccines / C. Russell Middaugh, Sangeeta B. Joshi -- Biophysical characterization of protein antigens within vaccine formulations / Padima Malyala, Derek O'Hagan, Manmohan Singh -- Structural characteristics predict the stability of HIV / Zohar Biron ... [et al.] -- Selection of optimal adjuvants and product factors that affect vaccine immunogenicity / Wei Wang, Manmohan Singh -- Lyophilization and stabilization of vaccines / James Chesko ... [et al.] -- Effect of buffers and stabilizers on vaccine stability and efficacy / Shireesh P. Apte, Sydney Ugwu -- Selection of final product containers / Luis Baez, Adrian Distler -- From the lab to the clinic : filing a phase I IND for an investigational vaccine / Kenneth G. Surowitz. |
| Record Nr. | UNINA-9910139627903321 |
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of vaccines : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava
| Development of vaccines : from discovery to clinical testing / / edited by Manmohan Singh, Indresh K. Srivastava |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2011 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina | 615/.372 |
| Altri autori (Persone) |
Manmohan Singh <1964 November 8->
SrivastaIndresh K |
| Soggetto topico |
Vaccines
Drug development Drug stability |
| ISBN |
1-283-17565-7
9786613175656 1-118-02363-3 1-118-02364-1 1-118-02362-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Microbial vaccines design : the reverse vaccinology approach / Roberto Rosini, Michele A. Barocchi, Rino Rappuoli -- Design and development of recombinant vaccines with viral properties / Gerd Lipowsky, Martin F. Bachmann -- Tools for vaccine design : prediction and validation of highly immunogenic and conserved class II epitopes, and development of epitope-driven vaccines / Anne S. De Groot ... [et al.] -- Virus like-particle vaccines advantages and challenges / Ted M. Ross ... [et al.] -- Design platforms of nanocapsules for human therapeutics or vaccines / Masaaki Kawano ... [et al.] -- Designing immunogens for vaccine development in reference to HIV / Aemro Kassa ... [et al.] --
Expression and purification of recombinant proteins for vaccine applications / Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava -- DNA vaccines for infectious diesase / Samuel Stepenson, Manmohan Singh, Indresh K. Srivastava -- Developing stable cell lines for the production of vaccine antigens / Xiaotian Zhong ... [et al.] -- Spectroscopy of vaccines / C. Russell Middaugh, Sangeeta B. Joshi -- Biophysical characterization of protein antigens within vaccine formulations / Padima Malyala, Derek O'Hagan, Manmohan Singh -- Structural characteristics predict the stability of HIV / Zohar Biron ... [et al.] -- Selection of optimal adjuvants and product factors that affect vaccine immunogenicity / Wei Wang, Manmohan Singh -- Lyophilization and stabilization of vaccines / James Chesko ... [et al.] -- Effect of buffers and stabilizers on vaccine stability and efficacy / Shireesh P. Apte, Sydney Ugwu -- Selection of final product containers / Luis Baez, Adrian Distler -- From the lab to the clinic : filing a phase I IND for an investigational vaccine / Kenneth G. Surowitz. |
| Record Nr. | UNINA-9910813272203321 |
| Hoboken, N.J., : John Wiley & Sons, c2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug stability and chemical kinetics / / Muhammad Sajid Hamid Akash, Kanwal Rehman, editors
| Drug stability and chemical kinetics / / Muhammad Sajid Hamid Akash, Kanwal Rehman, editors |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Gateway East, Singapore : , : Springer, , [2021] |
| Descrizione fisica | 1 online resource (XIV, 284 p. 22 illus., 13 illus. in color.) |
| Disciplina | 615.19 |
| Soggetto topico | Drug stability |
| ISBN | 981-15-6426-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1 Principles of pharmaceutical analysis in drug stability and chemical kinetics -- 2 Guidelines for drug stability and stability testing -- 3 Chemical kinetics and its applications in drug stability -- 4 Methods and protocols for drug stability studies -- 5 Physical basis of degradation of pharmaceutical products -- 6 Role of microbiological degradation on drug stability -- 7 Role of decomposition on drug stability -- 8 Role of catalysis in drug stability -- 9 Analytical techniques for the assessment of drug stability -- 10 Stability of pharmaceutical products -- 11 Role of kinetic models in drug stability -- 12 Stability studies of vaccines -- 13 Stability studies of proteinous compounds -- 14 Stability studies of extemporaneous pharmaceutical products -- 15 Stability studies of parenteral products -- 16 Stability studies of solid dosage forms. |
| Record Nr. | UNINA-9910426055803321 |
| Gateway East, Singapore : , : Springer, , [2021] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 | ||
| ||
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 | ||
| ||
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 | ||
| ||
Extended Stability for Parenteral Drugs / / $cMichelle C. Simpson, Eric G. Schaefer
| Extended Stability for Parenteral Drugs / / $cMichelle C. Simpson, Eric G. Schaefer |
| Autore | Simpson Michelle C. |
| Edizione | [Seventh edition.] |
| Pubbl/distr/stampa | Minneapolis : , : American Society of Health-System Pharmacists, , 2022 |
| Descrizione fisica | 1 online resource (440 pages) |
| Disciplina | 615.8/55 |
| Soggetto topico |
Drug stability
Drugs - Storage Home drug infusion therapy Parenteral feeding |
| Soggetto genere / forma | Databases. |
| ISBN | 1-58528-672-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910796066203321 |
|
Simpson Michelle C.
|
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| Minneapolis : , : American Society of Health-System Pharmacists, , 2022 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
-
Drug stability
(18)
- Photochemistry (3)
- Drug development (2)
- Drugs - Storage (2)
- Drugs - Testing (2)