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Breakthrough business models [[electronic resource] ] : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies
| Breakthrough business models [[electronic resource] ] : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies |
| Autore | Wizemann Theresa M |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2009 |
| Descrizione fisica | 1 online resource (149 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
WizemannTheresa M
RobinsonSally GiffinRobert B |
| Soggetto topico |
Orphan drugs - Government policy - United States
Pharmaceutical policy - United States Drugs - Design - United States |
| ISBN |
0-309-17816-9
1-282-08355-4 9786612083556 0-309-12089-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction and overview -- Current model for financing drug development : from concept through approval -- The Food and Drug Administration's Orphan Drug Program -- Diverse funding models -- Strategies for facilitating sharing of research materials and data -- Strategies of navigation intellectual property -- Strategies for facilitating clinical trials -- Summary. |
| Record Nr. | UNINA-9910777913803321 |
Wizemann Theresa M
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| Washington, D.C., : National Academies Press, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Breakthrough business models [[electronic resource] ] : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies
| Breakthrough business models [[electronic resource] ] : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2009 |
| Descrizione fisica | 1 online resource (149 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
WizemannTheresa M
RobinsonSally GiffinRobert B |
| Soggetto topico |
Orphan drugs - Government policy - United States
Pharmaceutical policy - United States Drugs - Design - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-08355-4
9786612083556 0-309-12089-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910454529203321 |
| Washington, D.C., : National Academies Press, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Breakthrough business models : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies
| Breakthrough business models : drug development for rare and neglected diseases and individualized therapies : workshop summary / / Theresa Wizemann, Sally Robinson, and Robert Giffin ; Forum on Health Sciences Policy, Institute of Medicine of the National Academies |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, 2009 |
| Descrizione fisica | 1 online resource (149 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
WizemannTheresa M
RobinsonSally GiffinRobert B |
| Soggetto topico |
Orphan drugs - Government policy - United States
Pharmaceutical policy - United States Drugs - Design - United States |
| ISBN |
0-309-17816-9
1-282-08355-4 9786612083556 0-309-12089-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction and overview -- Current model for financing drug development : from concept through approval -- The Food and Drug Administration's Orphan Drug Program -- Diverse funding models -- Strategies for facilitating sharing of research materials and data -- Strategies of navigation intellectual property -- Strategies for facilitating clinical trials -- Summary. |
| Record Nr. | UNINA-9910812068203321 |
| Washington, D.C., : National Academies Press, 2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals / / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals / / by John Geigert |
| Autore | Geigert John |
| Edizione | [4th ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (597 pages) |
| Disciplina |
615/.19
615.19 |
| Soggetto topico |
Biologicals
Biopharmaceutics Pharmaceutical chemistry Pharmacy Biologics Pharmaceutics |
| ISBN | 3-031-31909-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities. |
| Record Nr. | UNINA-9910731488803321 |
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Geigert John
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| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Chemical engineering in the pharmaceutical industry : R&D to manufacturing / / edited by David J. am Ende
| Chemical engineering in the pharmaceutical industry : R&D to manufacturing / / edited by David J. am Ende |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2011 |
| Descrizione fisica | 1 online resource (905 p.) |
| Disciplina |
615.19
615/.19 |
| Soggetto topico |
Pharmaceutical technology
Biochemical engineering Chemical engineering |
| ISBN |
1-5231-4387-8
1-118-08810-7 1-283-37261-4 9786613372611 0-470-88222-0 0-470-88221-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
CHEMICAL ENGINEERING IN THE PHARMACEUTICAL INDUSTRY: R&D to Manufacturing; CONTENTS; PREFACE; CONTRIBUTORS; CONVERSION TABLE; PART I: INTRODUCTION; 1 CHEMICAL ENGINEERING IN THE PHARMACEUTICAL INDUSTRY: AN INTRODUCTION; 2 CURRENT CHALLENGES AND OPPORTUNITIES IN THE PHARMACEUTICAL INDUSTRY; 3 CHEMICAL ENGINEERING PRINCIPLES IN BIOLOGICS: UNIQUE CHALLENGES AND APPLICATIONS; 4 DESIGNING A SUSTAINABLE PHARMACEUTICAL INDUSTRY: THE ROLE OF CHEMICAL ENGINEERS; 5 SCIENTIFIC OPPORTUNITIES THROUGH QUALITY BY DESIGN; PART II: ACTIVE PHARMACEUTICAL INGREDIENT (API)
6 THE ROLE OF CHEMICAL ENGINEERING IN PHARMACEUTICAL API PROCESS R&D7 REACTION KINETICS AND CHARACTERIZATION; 8 UNDERSTANDING RATE PROCESSES IN CATALYTIC HYDROGENATION REACTIONS; 9 CHARACTERIZATION AND FIRST PRINCIPLES PREDICTION OF API REACTION SYSTEMS; 10 MODELING, OPTIMIZATION, AND APPLICATIONS OF KINETIC MECHANISMS WITH OPENCHEM; 11 PROCESS SAFETY AND REACTION HAZARD ASSESSMENT; 12 DESIGN OF DISTILLATION AND EXTRACTION OPERATIONS; 13 CRYSTALLIZATION DESIGN AND SCALE-UP; 14 SCALE-UP OF MIXING PROCESSES: A PRIMER; 15 STIRRED VESSELS: COMPUTATIONAL MODELING OF MULTIPHASE FLOWS AND MIXING 16 MEMBRANE SYSTEMS FOR PHARMACEUTICAL APPLICATIONS17 DESIGN OF FILTRATION AND DRYING OPERATIONS; 18 THE DESIGN AND ECONOMICS OF LARGE-SCALE CHROMATOGRAPHIC SEPARATIONS; 19 MILLING OPERATIONS IN THE PHARMACEUTICAL INDUSTRY; 20 PROCESS SCALE-UP AND ASSESSMENT; 21 SCALE-UP DOS AND DON'TS; 22 KILO LAB AND PILOT PLANT MANUFACTURING; 23 PROCESS DEVELOPMENT AND CASE STUDIES OF CONTINUOUS REACTOR SYSTEMS FOR PRODUCTION OF API AND PHARMACEUTICAL INTERMEDIATES; 24 DRUG SOLUBILITY AND REACTION THERMODYNAMICS; 25 THERMODYNAMICS AND RELATIVE SOLUBILITY PREDICTION OF POLYMORPHIC SYSTEMS 26 TOWARD A RATIONAL SOLVENT SELECTION FOR CONFORMATIONAL POLYMORPH SCREENING27 MOLECULAR THERMODYNAMICS FOR PHARMACEUTICAL PROCESS MODELING AND SIMULATION; 28 THE ROLE OF SIMULATION AND SCHEDULING TOOLS IN THE DEVELOPMENT AND MANUFACTURING OF ACTIVE PHARMACEUTICAL INGREDIENTS; PART III: ANALYTICAL METHODS AND APPLIED STATISTICS; 29 QUALITY BY DESIGN FOR ANALYTICAL METHODS; 30 ANALYTICAL CHEMISTRY FOR API PROCESS ENGINEERING; 31 QUANTITATIVE APPLICATIONS OF NMR SPECTROSCOPY; 32 EXPERIMENTAL DESIGN FOR PHARMACEUTICAL DEVELOPMENT; 33 MULTIVARIATE ANALYSIS FOR PHARMACEUTICAL DEVELOPMENT PART IV: DRUG PRODUCTS34 PROCESS MODELING TECHNIQUES AND APPLICATIONS FOR SOLID ORAL DRUG PRODUCTS; 35 PROCESS DESIGN AND DEVELOPMENT FOR NOVEL PHARMACEUTICAL DOSAGE FORMS; 36 DESIGN OF SOLID DOSAGE FORMULATIONS; 37 CONTROLLED RELEASE TECHNOLOGY AND DESIGN OF ORAL CONTROLLED RELEASE DOSAGE FORMS; 38 DESIGN AND SCALE-UP OF DRY GRANULATION PROCESSES; 39 WET GRANULATION PROCESSES; 40 SPRAY ATOMIZATION MODELING FOR TABLET FILM COATING PROCESSES; 41 THE FREEZE-DRYING PROCESS: THE USE OF MATHEMATICAL MODELING IN PROCESS DESIGN, UNDERSTANDING, AND SCALE-UP 42 ACHIEVING A HOT MELT EXTRUSION DESIGN SPACE FOR THE PRODUCTION OF SOLID SOLUTIONS |
| Record Nr. | UNINA-9910140880003321 |
| Hoboken, New Jersey : , : Wiley, , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Chemistry and medicines [[electronic resource] ] : an introductory text / / James R. Hanson
| Chemistry and medicines [[electronic resource] ] : an introductory text / / James R. Hanson |
| Autore | Hanson James Ralph |
| Pubbl/distr/stampa | Cambridge, : RSC Pub., c2006 |
| Descrizione fisica | 1 online resource (167 p.) |
| Disciplina | 615/.19 |
| Soggetto topico | Pharmaceutical chemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-62870-140-4
1-84755-540-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chemistry and Medicines Folder_publicity; i_iv; v_vi; vii-x; 001_019; 020_040; 041_063; 064_084; 085_104; 105_128; 129_141; 142_143; 144_150; 151_156 |
| Record Nr. | UNINA-9910455220203321 |
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Hanson James Ralph
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| Cambridge, : RSC Pub., c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Chemistry and medicines : an introductory text / / James R. Hanson
| Chemistry and medicines : an introductory text / / James R. Hanson |
| Autore | Hanson James Ralph |
| Pubbl/distr/stampa | Cambridge : , : RSC Pub., , 2006 |
| Descrizione fisica | 1 online resource (x, 156 pages) : illustrations |
| Disciplina | 615/.19 |
| Soggetto topico | Pharmaceutical chemistry |
| ISBN |
1-78801-826-5
1-62870-140-4 1-84755-540-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | General principles of medicinal chemistry Neurotransmitters as targets Medicinal chemistry and the central nervous system Local and circulatory hormone targets Anti-infective agents Cancer chemotherapy |
| Record Nr. | UNINA-9910778311803321 |
|
Hanson James Ralph
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| Cambridge : , : RSC Pub., , 2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Chemistry and medicines : an introductory text / / James R. Hanson
| Chemistry and medicines : an introductory text / / James R. Hanson |
| Autore | Hanson James Ralph |
| Pubbl/distr/stampa | Cambridge : , : RSC Pub., , 2006 |
| Descrizione fisica | 1 online resource (x, 156 pages) : illustrations |
| Disciplina | 615/.19 |
| Soggetto topico | Pharmaceutical chemistry |
| ISBN |
1-78801-826-5
1-62870-140-4 1-84755-540-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | General principles of medicinal chemistry Neurotransmitters as targets Medicinal chemistry and the central nervous system Local and circulatory hormone targets Anti-infective agents Cancer chemotherapy |
| Record Nr. | UNINA-9910812433403321 |
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Hanson James Ralph
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| Cambridge : , : RSC Pub., , 2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Chemogenomics in drug discovery : a medicinal chemistry perspective / / edited by Hugo Kubinyi and Gerhard Muller
| Chemogenomics in drug discovery : a medicinal chemistry perspective / / edited by Hugo Kubinyi and Gerhard Muller |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2004 |
| Descrizione fisica | 1 online resource (489 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
KubinyiHugo
MullerGerhard <1963-> |
| Collana | Methods and principles in medicinal chemistry |
| Soggetto topico |
Pharmaceutical chemistry
Drug development Medicaments - Developpement Chimie pharmaceutique Medicaments - Recherche Medicaments - Conception |
| ISBN |
1-280-51949-5
9786610519491 3-527-60394-8 3-527-60402-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Target family-directed masterkeyes in chemogenomics / Gehard Muller -- Drug discovery from side effects / Hugo Kubinyi -- The value of chemical genetics in drug discovery / Keith Russell and William F. Michne -- Structural aspects of binding site similarity: a 3D upgrade for chemogenomics / Andreas Bergner and Judith Gunther -- The contribution of molecular informatics to chemogenomics: knowledge-based discovery of biological targets and chemical lead compounds / Edgar Jacoby, Ansgar Schuffenhauer, and Pierre Acklin -- Chemical kinomics / Bert M. Klebl, Henrik Daub, and Gyorgy Keri -- Structural aspects of kinases and their inhibitors / Rogier Buijsman -- A chemical genomics approach for ion channel modulators / Karl-Heinz Baringhaus and Gerhard Hessler -- Phosphodiesterase inhibitors: a chemogenomic view / Martin Hendrix and Christopher Kallus -- Proteochemometrics: a tool for modeling the molecular interaction space / Jarl E.S. Wikberg, Maris Lapinsch, and Peteris Prusis -- Some principles related to chemogenomics in compound library and template design for GPCRs / Thomas R. Webb -- Computational filters in lead generation: targeting drug-like chemotypes / Wolfgang Guba and Olivier Roche -- Navigation in chemical space: ligand-based design of focused compound libraries / Gisbert Schneider and Petra Schneider -- Natural product-derived compound libraries and protein structure similarity as guiding principles for the discovery of drug candidates / Marcus A. Koch and Herbert Waldmann -- Combinatorial chemistry in the age of chemical genomics / Reni Joseph and Prabhat Arya. |
| Record Nr. | UNINA-9910877452303321 |
| Weinheim, : Wiley-VCH, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Chiral drugs : chemistry and biological action / / edited by Guo-Qiang Lin, Qi-Dong You, Jie-Fei Cheng
| Chiral drugs : chemistry and biological action / / edited by Guo-Qiang Lin, Qi-Dong You, Jie-Fei Cheng |
| Pubbl/distr/stampa | Hoboken, N.J. : , : Wiley, , 2011 |
| Descrizione fisica | 1 online resource (x, 456 pages) : illustrations |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
LinGuo-Qiang <1943->
YouQi-Dong ChengJie-Fei |
| Soggetto topico |
Chiral drugs
Drug development Structure-activity relationships (Biochemistry) |
| ISBN |
1-283-23983-3
9786613239839 1-118-07563-3 1-118-07564-1 1-118-07562-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Machine generated contents note: Chapter 1. Overview of chirality and chiral drugs (Guo-Qiang Lin, Jiange Zhang and Jie-Fei Cheng). -- Chapter 2. Chiral drugs through asymmetric synthesis (Guo-Quiang Lin and Xing-Wen Sun). -- Chapter 3. Chiral drugs via biocatalytical approaches (Jianqiang Wang and Wenya Lu). -- Chapter 4. Chiral resolution (Qi-Dong You). -- Chapter 5. Fluorine-containing chiral drugs (Xiao-Long Qiu, Xuyi Yue and Feng-Ling Qing). -- Chapter 6. Industrial application of chiral technologies (Hui-Ying (Harry) Li, Rui Liu, Carl Behrens, and Chao-Ying Ni). -- Chapter 7. Computation modeling study on mechanism-of-action of chiral drugs (Deping Wang and Eric Gu). -- Chapter 8. Pharmacology of chiral drugs (Yongge Liu and Xiao-Hui Gu). -- Chapter 9. Pharmacokinetics of chiral drugs (Hanqing Dong, Xiaochuan Guo and Zengbiao Li). -- Chapter 10. Toxicology of chiral drugs (Guang Yang and Hai-Zhi Bu). -- Chapter 11. Representative chiral drugs (Jiangqin Sun, Dingguo Liu and Zhimin Wang). |
| Record Nr. | UNINA-9910139598603321 |
| Hoboken, N.J. : , : Wiley, , 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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