Drug products for clinical trials. (2006)

• Record Type: Book
• Further Information: Note: Edited by Donald C. Monkhouse, Charles F. Carney, James L. Clark.
• Other Names: Monkhouse, Donald C; Carney, Charles (Charles F.); Clark, Jim
• Contents: Front cover; Preface; Contents; Contributors; The Clinical Trials Material Professional: A Changing Role; INTRODUCTION; Decline in the Pharmaceutical Industry; FDA Initiatives; ADMINISTRATIVE/ORGANIZATIONAL ROLE Company Structure; Re-Engineering R & D; Project Management; Communication Breakdown; OUTSIDE INFLUENCES Outsourcing; Counterfeiting; Drugs of Abuse; Extemporaneous Compounding; European Regulations; CONCLUSIONS; REFERENCES; Discovery and Formulation Trends for the Clinical Trials Material Professional; DISCOVERY TRENDS Outlook for Drug Discovery; Formulatability and Drugability. High Throughput ScreeningIn Silico Approaches; Pharmacogenomics; Miscellaneous Considerations; PHYSICOCHEMICAL CHARACTERIZATION Rapid Crystallography; Amorphous Solids; Calorimetry; X-Ray Diffraction; Inverse Gas Chromatography; DISSOLUTION AND ABSORPTION Biopharmaceutical Classification System; Metabolism; Regional Absorption; Effect of Food; Solubility Enhancement; ALTERNATE ROUTES OF ADMINISTRATION Inhalation; Colonic; Nasal; Gastro-Retention/Bioadhesives; Depot Formulations; Absorption Enhancers; Transporters; BIOLOGICALS Peptides and Proteins; Pegylation; Monoclonal Antibodies. DRUG DELIVERY/PRODUCTSLife Cycle/Alternate Routes; Combination Products; Injection Devices; Transdermal Systems; Tissue Engineering; Cells; Gene Delivery; Chronotherapeutics; Nanomedicine; CONCLUSIONS; REFERENCES; Manufacturing and Clinical Medicine Trends for the Clinical Trials Material Professional; INTRODUCTION; MANUFACTURING PROCESSES Dearth of New Excipients; Super Critical Fluid Processing; Rapid Prototyping; Electrostatic Deposition; NROBE2; Robots; Hot Melt Extrusion; Orally Dispersing Tablets; Dissolvable Films; Parenteral Processing. MANUFACTURING TRENDS Contract Manufacturing OrganizationsGeneral Manufacturing; Process Analytical Technology (PAT); Process Analyzers; Rapid Microbiology Testing; Active Pharmaceutical Ingredients; Six Sigma; Continuous Processing; INFORMATION TECHNOLOGY; New Electronic Clinical Trial Management Systems; Smart Tags or Radio Frequency Identification (RFID) Tags; Process Analytical Technology; Petaflop and Grid Computing; Predictive Biosimulation; Pervasive Computing; Web-Scale Mining and Advanced Text Analytics; CLINICAL Toxicology; Experimental Medicine; Computerized Data; Remote Monitoring. Conduct of Clinical TrialsDEVELOPMENT CONSIDERATIONS; QSR Compliance; Importance of Patents; CONCLUSIONS: CONSIDERATIONS FOR THE CLINICAL TRIALS MATERIAL PROFESSIONAL; REFERENCES; Quality Assurance Systems for Global Companies; INTRODUCTION; RESEARCH AND DEVELOPMENT QUALITY SYSTEM Good Business Practices; Good Scientific Practices; Regulatory Perspective; GLOBAL QUALITY ASSURANCE FOR CLINICAL SUPPLIES PREPARATION; SUMMARY AND CONCLUSIONS; REFERENCES; Special Facilities for Developing, Manufacturing, and Packaging Potent or Hazardous Drug Products; INTRODUCTION.
• Edition: 2nd ed
• Publisher Details: New York : Taylor & Francis
• Publication Date: 2006
• Extent: 1 online resource (xvi, 399 pages), illustrations
• Subjects: 615/.19; Drugs -- Testing; Clinical Trials -- standards; Drug Industry -- standards; Drugs -- Testing; Quality Control; Médicaments -- Essais cliniques; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drugs -- Testing; Drug Industry -- standards; Clinical Trials -- standards; Quality Control; Electronic books; Electronic books
• Languages: English
• ISBNs: 9780849352768; 0849352762
• Related ISBNs: 082475462X; 9780824754624
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.