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Clinical trials handbook [[electronic resource] /] / edited by Shayne Cox Gad
| Clinical trials handbook [[electronic resource] /] / edited by Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, NJ, : Wiley, c2009 |
| Descrizione fisica | 1 online resource (1247 p.) |
| Disciplina |
615.1
615.580724 615/.1 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Testing
Clinical trials |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-282-36844-3
9786612368448 0-470-46636-7 0-470-46635-9 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Clinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials
9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 Gynecology Randomized Control Trials; 10.7 Special Population Studies (Healthy Patient Studies); 10.8 Musculoskeletal Disorders; 10.9 Oncology 10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration10.11 Paediatrics; 10.12 Clinical Trials in Dementia; 10.13 Clinical Trials in Urology; 10.14 Clinical Trials on Cognitive Drugs; 10.15 Bridging Studies in Pharmaceutical Safety Assessment; 10.16 Brief History of Clinical Trials on Viral Vaccines; 11 Methods of Randomization; 12 Randomized Controlled Trials; 13 Cross-Over Designs; 14.1 Biomarkers; 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis; 15 Review Boards 16 Size of Clinical Trials17 Blinding and Placebo; 18 Pharmacology; 19 Modeling and Simulation in Clinical Drug Development; 20 Monitoring; 21 Inference Following Sequential Clinical Trials; 22 Statistical Methods for Analysis of Clinical Trials; 23 Explanatory and Pragmatic Clinical Trials; 24.1 Ethics of Clinical Research in Durg Trials; 24.2 Ethical Issues in Clinical Research; 25 Regulations; 26 Future Challenges in Design and Ethics of Clinical Trials; 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development; Index |
| Record Nr. | UNINA-9910455072803321 |
| Hoboken, NJ, : Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical trials handbook [[electronic resource] /] / edited by Shayne Cox Gad
| Clinical trials handbook [[electronic resource] /] / edited by Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, NJ, : Wiley, c2009 |
| Descrizione fisica | 1 online resource (1247 p.) |
| Disciplina |
615.1
615.580724 615/.1 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Testing
Clinical trials |
| ISBN |
1-282-36844-3
9786612368448 0-470-46636-7 0-470-46635-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Clinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials
9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 Gynecology Randomized Control Trials; 10.7 Special Population Studies (Healthy Patient Studies); 10.8 Musculoskeletal Disorders; 10.9 Oncology 10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration10.11 Paediatrics; 10.12 Clinical Trials in Dementia; 10.13 Clinical Trials in Urology; 10.14 Clinical Trials on Cognitive Drugs; 10.15 Bridging Studies in Pharmaceutical Safety Assessment; 10.16 Brief History of Clinical Trials on Viral Vaccines; 11 Methods of Randomization; 12 Randomized Controlled Trials; 13 Cross-Over Designs; 14.1 Biomarkers; 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis; 15 Review Boards 16 Size of Clinical Trials17 Blinding and Placebo; 18 Pharmacology; 19 Modeling and Simulation in Clinical Drug Development; 20 Monitoring; 21 Inference Following Sequential Clinical Trials; 22 Statistical Methods for Analysis of Clinical Trials; 23 Explanatory and Pragmatic Clinical Trials; 24.1 Ethics of Clinical Research in Durg Trials; 24.2 Ethical Issues in Clinical Research; 25 Regulations; 26 Future Challenges in Design and Ethics of Clinical Trials; 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development; Index |
| Record Nr. | UNINA-9910778685003321 |
| Hoboken, NJ, : Wiley, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of therapeutic agents handbook [[electronic resource] /] / [edited by] Shayne Cox Gad
| Development of therapeutic agents handbook [[electronic resource] /] / [edited by] Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
| Descrizione fisica | 1 online resource (1278 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Research
Drugs - Design Pharmaceutical chemistry Drug development Drug Design Chemistry, Pharmaceutical - methods |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-118-07711-3
1-283-31590-4 9786613315908 1-118-07710-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Fundamentals and concepts -- pt. 2. Methods and techniques in drug discovery and development -- pt. 3. Therapeutics topics. |
| Record Nr. | UNINA-9910457204303321 |
| Hoboken, N.J., : John Wiley & Sons, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of therapeutic agents handbook [[electronic resource] /] / [edited by] Shayne Cox Gad
| Development of therapeutic agents handbook [[electronic resource] /] / [edited by] Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
| Descrizione fisica | 1 online resource (1278 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Research
Drugs - Design Pharmaceutical chemistry Drug development Drug Design Chemistry, Pharmaceutical - methods |
| ISBN |
1-118-07711-3
1-283-31590-4 9786613315908 1-118-07710-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Fundamentals and concepts -- pt. 2. Methods and techniques in drug discovery and development -- pt. 3. Therapeutics topics. |
| Record Nr. | UNINA-9910781962103321 |
| Hoboken, N.J., : John Wiley & Sons, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of therapeutic agents handbook / / [edited by] Shayne Cox Gad
| Development of therapeutic agents handbook / / [edited by] Shayne Cox Gad |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
| Descrizione fisica | 1 online resource (1278 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Research
Drugs - Design Pharmaceutical chemistry Drug development |
| ISBN |
9786613315908
9781118077115 1118077113 9781283315906 1283315904 9781118077108 1118077105 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. Fundamentals and concepts -- pt. 2. Methods and techniques in drug discovery and development -- pt. 3. Therapeutics topics. |
| Record Nr. | UNINA-9910953483103321 |
| Hoboken, N.J., : John Wiley & Sons, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug discovery handbook [[electronic resource] /] / edited by Shayne Cox Gad
| Drug discovery handbook [[electronic resource] /] / edited by Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2005 |
| Descrizione fisica | 1 online resource (1493 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Drugs - Research
Drug development Drugs - Design Pharmaceutical chemistry |
| ISBN |
1-280-27707-6
9786610277070 0-470-30589-4 0-471-72877-2 0-471-72878-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Drug discovery in the 21st century: an introduction / Shayne C. Gad -- Natural products / Charles B. Spainhour -- Cancer cell proteomics using molecular aptamers / Weihong Tan, Zehui Cao, Dihua Shangguang -- Molecular similarity methods and QSAR models as tools for virtual screening / Jürgen Bajorath -- Systems biology: applications in drug discovery / Sean Ekins ...[et al.] -- High throughput flow cytometry / Larry A. Sklar ... [et al.] -- Combining NMR spectral information with associated structural features to form computationally non-intensive, rugged, and objective models of biological activity / Richard Beger, Dan A. Buzatu, Jon G. Wilkes -- Using Microsoft Excel as a laboratory data management tool / A. Erik Rubin, Mark F. Russo, William Neil -- The age of regulation / Sandy Weinberg, Gerald J. Whartenby -- Simultaneous screening of multiple cell lines using the CellCardtm system / Oren E. Beske -- Protein x-ray crystallography in drug discovery / Peter Nollert ...[et al.] -- Biological and chemistry assays available during drug discovery and developability assessment / Duane B. Lakings -- Strategies and methods in monitoring and targeting protein-protein interactions / Arianna Loregian, Giorgio Palù -- High throughput screening: evolution of technology and methods -- Martyn N. Banks ... [et al.] -- Metal-enhanced fluorescence: application to high-throughput screening and drug discovery / Kadir Aslan .. [et al,] -- Methods for the design and analysis of replicate-experiment studies to establish assay reproducibility and the equivalence of two potency assays / Brian J. Eastwood ... [et al.] -- Coupled luminescent methods in drug discovery: three-minute assays for cytotoxicity and phosphatase activity / Michael J. Corey, Robert J. Kinders -- Design and pharmaceutical applications of prodrugs / Tomi Jarvinen ... [et al.] -- GABA and glutamate receptor ligands and their therapeutic potential in CNS disorders / Ulf Madsen ... [et al.] -- Cardiac sarcolemmal ATP-sensitive potassium channel antagonists: novel ischemia-selective antiarrhythmic agents / George E. Billman -- Factors influencing the efficacy of mediator-specific anti-inflammatory, glucocorticoid and anti-coagulant therapies for sepsis / Peter C. Minneci ... [et al.] -- Combinatorial chemistry in the drug discovery process / Nathan T. Ross, Brian R. McNaughton, Benjamin L. Miller -- Herbal medicines and animal models of gastrointestinal diseases / C.H. Cho, J.K.S. Ko -- Endocrine and metabolic agents / Brian L. Furman -- Respiratory viruses / Paul D. Olivo -- Strategies in the design of antiviral drugs / Erik De Clercq, Piet Herdewijn -- Protein kinase inhibitors in drug discovery / Keykavous Parang, Gongqin Sun -- RNA-based therapies / Ingmar Hoerr, Steve Pascolo -- Novel imaging agents for molecular MR imaging of cancer / Dmitri Artemov, Zaver M. Bhujwalla -- Genomics-based drug discovery / Spyro Mousses -- Cancer drug discovery / Susan Mooberry. |
| Record Nr. | UNINA-9910783437503321 |
| Hoboken, N.J., : Wiley-Interscience, c2005 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Handbook of pharmaceutical biotechnology / / edited by Shayne Cox Gad
| Handbook of pharmaceutical biotechnology / / edited by Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J. : , : Wiley-Interscience, , 2007 |
| Descrizione fisica | 1 online resource (xix, 1659 pages) : illustrations |
| Disciplina | 615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical biotechnology
Pharmaceutical chemistry |
| ISBN |
1-280-90013-X
9786610900138 0-470-11711-7 0-470-11710-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
HANDBOOK OF PHARMACEUTICAL BIOTECHNOLOGY; CONTRIBUTORS; CONTENTS; Preface; 1.1 From Gene to Product: The Advantage of Integrative Biotechnology; 1.2 Sequencing the Human Genome: Was It Worth It?; 1.3 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules; 1.4 Integrated Development of Glycobiologics: From Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems; 1.5 R&D Paradigm Shift and Billion-Dollar Biologics
2 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care 3.1 Toxicogenomics; 3.2 Preclinical Pharmacokinetics; 3.3 Strategies for the Cytosolic Delivery of Macromolecules: An Overview; 4.1 Basic Issues in the Manufacture of Macromoleucles; 4.2 Process Validation for Biopharmaceuticals; 4.3 Stability Assessment and Formulation Characterization; 4.4 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development 4.5 PEGylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism 4.6 Unexpected Benefits of a Formulation: Case Study with Erythropoetin; 5.1 Capillary Separation Techniques; 5.2 Pharmaceutical Bioassay; 5.3 Analytical Considerations for Immunoassays for Macromolecules; 5.4 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids; 5.5 Bioanalytical Method Validation for Macromolecules; 5.6 Microarrays in Drug Discovery and Development; 5.7 Genetic Markers and Genotyping Analyses for Genetic Disease Studies 6.1 Proteins: Hormones, Enzymes, and Monoclonal\Antibodies-Background 6.2 Formulation and Delivery Issues of Therapeutic Proteins; 6.3 Pharmacokinetics; 6.4 Immunogenicity of Therapeutic Proteins; 6.5 Development and Characterization of High-Affinity Anti-Topotecan IgG and Fab Fragments; 6.6 Recombinant Antibodies for Pathogen Detection and Immunotherapy; 6.7 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted in situ Radiotherapy of Malignancies; 7.1 Gene Therapy-Basic Principles and the Road from Bench to Bedside 7.2 Plasmid DNA and Messenger RNA for Therapy 7.3 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies; 7.4 Pharmacokinetics of Nucleic-Acid-Based Therapeutics; 7.5 Case Studies-Development of Oligonucleotides; 7.6 RNA Interference: The Next Gene-Targeted Medicine; 7.7 Delivery Systems for Peptides/Oligonucleotides and Lipophilic Nucleoside Analogs; 8.1 Growth Factors and Cytokines; 8.2 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics; 9 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin; 10.1 Production and Purification of Adenovirus Vectors for Gene Therapy |
| Record Nr. | UNINA-9910784404203321 |
| Hoboken, N.J. : , : Wiley-Interscience, , 2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical manufacturing handbook : production and processes / / [edited by] Shayne Cox Gad
| Pharmaceutical manufacturing handbook : production and processes / / [edited by] Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J. : , : Wiley-Interscience, , 2008 |
| Descrizione fisica | 1 online resource (xiii, 1370 pages) : illustrations |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical technology
Materia medica |
| ISBN |
1-281-23751-5
9786611237516 0-470-25981-7 0-470-25980-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 MANUFACTURING SPECIALTIES; 1.1 Biotechnology-Derived Drug Product Development; 1.2 Regulatory Considerations in Approval on Follow-On Protein Drug Products; 1.3 Radiopharmaceutical Manufacturing; SECTION 2 ASEPTIC PROCESSING; 2.1 Sterile Product Manufacturing; SECTION 3 FACILITY; 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors; 3.2 Packaging and Labeling; 3.3 Clean-Facility Design, Construction, and Maintenance Issues
SECTION 4 NORMAL DOSAGE FORMS; 4.1 Solid Dosage Forms; 4.2 Semisolid Dosages: Ointments, Creams, and Gels; 4.3 Liquid Dosage Forms; SECTION 5 NEW DOSAGE FORMS; 5.1 Controlled-Release Dosage Forms; 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein; 5.3 Liposomes and Drug Delivery; 5.4 Biodegradable Nanoparticles; 5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation; 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 5.7 Nasal Powder Drug Delivery; 5.8 Aerosol Drug Delivery; 5.9 Ocular Drug Delivery; 5.10 Microemulsions as Drug Delivery Systems; 5.11 Transdermal Drug Delivery; 5.12 Vaginal Drug Delivery; SECTION 6 TABLET PRODUCTION; 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization; 6.2 Role of Preformulation in Development of Solid Dosage Forms; 6.3 Tablet Design; 6.4 Tablet Production Systems; 6.5 Controlled Release of Drugs from Tablet Coatings; 6.6 Tablet Compression; 6.7 Effects of Grinding in Pharmaceutical Tablet Production 6.8 Oral Extended-Release Formulations; SECTION 7 ROLE OF NANOTECHNOLOGY; 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field; 7.2 Nanotechnology in Pharmaceutical Manufacturing; 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety; 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications; INDEX |
| Record Nr. | UNINA-9910777030103321 |
| Hoboken, N.J. : , : Wiley-Interscience, , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad
| Pharmaceutical manufacturing handbook : regulations and quality / / [edited by] Shayne Cox Gad |
| Pubbl/distr/stampa | Hoboken, N.J. : , : Wiley-Interscience, , 2008 |
| Descrizione fisica | 1 online resource (857 pages) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical technology - Quality control
Pharmacy - Law and legislation - United States Drugs - Law and legislation - United States |
| ISBN |
1-281-23752-3
9786611237523 0-470-25983-3 0-470-25982-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES
2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY 7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEX |
| Record Nr. | UNINA-9910785000603321 |
| Hoboken, N.J. : , : Wiley-Interscience, , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical manufacturing handbook : production and processes / / [edited by] Shayne Cox Gad
| Pharmaceutical manufacturing handbook : production and processes / / [edited by] Shayne Cox Gad |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2008 |
| Descrizione fisica | 1 online resource (xiii, 1370 pages) : illustrations |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) | GadShayne C. <1948-> |
| Collana | Pharmaceutical Development Series |
| Soggetto topico |
Pharmaceutical technology
Materia medica |
| ISBN |
9786611237516
9781281237514 1281237515 9780470259818 0470259817 9780470259801 0470259809 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 MANUFACTURING SPECIALTIES; 1.1 Biotechnology-Derived Drug Product Development; 1.2 Regulatory Considerations in Approval on Follow-On Protein Drug Products; 1.3 Radiopharmaceutical Manufacturing; SECTION 2 ASEPTIC PROCESSING; 2.1 Sterile Product Manufacturing; SECTION 3 FACILITY; 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors; 3.2 Packaging and Labeling; 3.3 Clean-Facility Design, Construction, and Maintenance Issues
SECTION 4 NORMAL DOSAGE FORMS; 4.1 Solid Dosage Forms; 4.2 Semisolid Dosages: Ointments, Creams, and Gels; 4.3 Liquid Dosage Forms; SECTION 5 NEW DOSAGE FORMS; 5.1 Controlled-Release Dosage Forms; 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein; 5.3 Liposomes and Drug Delivery; 5.4 Biodegradable Nanoparticles; 5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation; 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 5.7 Nasal Powder Drug Delivery; 5.8 Aerosol Drug Delivery; 5.9 Ocular Drug Delivery; 5.10 Microemulsions as Drug Delivery Systems; 5.11 Transdermal Drug Delivery; 5.12 Vaginal Drug Delivery; SECTION 6 TABLET PRODUCTION; 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization; 6.2 Role of Preformulation in Development of Solid Dosage Forms; 6.3 Tablet Design; 6.4 Tablet Production Systems; 6.5 Controlled Release of Drugs from Tablet Coatings; 6.6 Tablet Compression; 6.7 Effects of Grinding in Pharmaceutical Tablet Production 6.8 Oral Extended-Release Formulations; SECTION 7 ROLE OF NANOTECHNOLOGY; 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field; 7.2 Nanotechnology in Pharmaceutical Manufacturing; 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety; 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications; INDEX |
| Record Nr. | UNINA-9910967615803321 |
| Hoboken, N.J., : Wiley-Interscience, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
