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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book , Date: 15/01/2004
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system life cycle using a structured top-down approach. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
Prices
| Print: | $ 229.95 / £ 115.00 |
A Practical Guide to Quality Management in Clinical Trial Research
Book
Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry.
Prices
| Print: | $ 229.95 / £ 115.00 |
Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation
Book
Focusing on the three most critical components that successfully bring an API to market - process development, manufacturing and governmental regulation and approval - this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.
Prices
| Print: | $ 229.95 / £ 115.00 |
Advanced Drug Formulation Design to Optimize Therapeutic Outcomes
Book , Date: 25/09/2007
This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states. It discusses nanoparticle systems for cancer treatments, and also presents cutting edge immono-regulation agents for transplantation and the local targeting of drugs, especially poorly water-soluble drugs to provide enhanced therapeutic outcomes. In addition, this title highlights areas of therapy showing the most promise for improvement in clinical outcomes via advanced formulation design.
Prices
| Print: | £ 125.00 / $ 249.95 |
Allosteric Receptor Modulation in Drug Targeting
Book
Offering a wide array of illustrations and tables in every chapter, this book extensively covers the principles of allosterism in reference to drug action and progresses to a detailed examination of individual ionotropic and G-protein coupled receptor systems, helping those new to the subject understand the importance of allosterism and providing those already working in the field with specific reference information. This title provides in-depth chapters on basic principles of allosterism and its significance at GABAA 5HT3 nicotinic, and GABAB, receptors, ionotropic and metabotropic receptors for glutamate, muscarinic receptors and alpha 2 adrenoceptors to provide a firm foundation to the subject.
Prices
| Print: | £ 115.00 / $ 229.95 |
Analytical Techniques for Biopharmaceutical Development
Book
Providing a valuable survey of exploratory methods commonly used during the preclinical, clinical and commercial phases of development, Analytical Techniques for Biopharmaceutical Development assists scientists in the selection and application of analytical techniques for biopharmaceutical identification, formulation and assessment. A reliable guide to the selection and combination of techniques for rapid and efficient biopharmaceutical characterization, the book examines methods to ensure the purity, potency, quality and performance of drug compounds. It presents clear and concise descriptions of various techniques for protein analysis.
Prices
| Print: | £ 115.00 / $ 229.95 |
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