Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.

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Pharmacokinetics in Drug Discovery and Development

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

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Practical Guide to Clinical Data Management

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.

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Polymers in Drug Delivery

In recent years there has been an explosion in the use of polymers to solve various biomedical problems. Polymers play a crucial role in controlling drug release rate, enhancing drug solubility and uptake, and limiting drug degradation and toxicity. Polymers in Drug Delivery is a state-of-the-art documentation and review of all areas in which polymers are used in drug delivery, including hydrogels, soluble polymer drug conjugates, polymeric vesicles and micelles, microspheres, nanoparticles, polymeric in tissue engineering, and more. It is a readily accessible volume suitable for drug delivery scientists and as reading for advanced pharmaceutics students and others new to the field.

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Nanoparticulate Drug Delivery Systems

Since the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery. This expertly written guide addresses the scientific methodologies, formulation, processing, applications, recent trends, and emerging technologies in the research of nanoparticulate drug delivery systems (NPDDS). It extensively covers applications of NPDDS, including lipid nanoparticles for dermal applications, nanocarriers for the treatment of restenosis, ocular, central nervous system, and gastrointestinal applications, and use as an adjuvant for vaccine development

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Cosmetic Formulation of Skin Care Products

Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care products including advances in formulation and development, raw materials and active ingredients, compound testing, and clinical assessment. Organized by product category, then by body application area, this guide supplies all one needs to know to create effective skin care products for men and women in a diverse range of ethnic populations.

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Troubleshooting LC Systems: A Comprehensive Approach to Troubleshooting LC Equipment and Separations

Major advances in instrumentation and technology have made high-performance liquid chromatography (HPLC) a pervasive tool in virtually all areas of chemical and biomedical research today. Despite HPLC's enormous growth, technical problems still bedevil most users at least occasionally.Based on their immensely successful short courses, Dolan and Snyder's landmark new book --Troubleshooting LC Systems--now makes available to every practicing chromatographer the authors' wealth of expertise from years of hands-on troubleshooting of real-world LC problems--problems that routinely cause crises and unproductive downtime in nearly every lab.Believing that successful troubleshooting requires an understanding of the basics, Dolan and Snyder open by setting forth all the fundamental principles of LC operation, then move on to a microscopic description of all the elements of LC devices, to lay out their optimal preventive maintenance routines, and ultimately to offer an unprecedentedly thorough treatment of each and every facet of troubleshooting.Displaying a special tutorial mastery--honed to a fineness during their ongoing teaching and consulting activities, and a well-received feature column in LC Magazine--the book's chapters cover: automation and robotics • approaches to troubleshooting • reactions of samples • basic separation techniques • valves, tubing, syringes • band broadening and tailing • preventive maintenance • column packing and flushing • individual LC modules • troubleshooting principles • reagents and buffering • specific problems in separation • ghost and vacancy peaks • quantitation and calibration • pumps, seals, and pistons • gradient elution problems • column composition • concentration and blockages • sample cleanup • temperature and mixing effects • detectors and recorders • column packing and flushing.In short, Dolan and Snyder's eminently practical new guide to Troubleshooting LC Systems is an essential laboratory handbook--one that empowers expert and novice chromatographer alike to solve every sort of practical laboratory problem on a day-to-day basis. No one using an LC system should be without it!

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Modern Practice of Gas Chromatography

The bible of gas chromatography-offering everything the professional and the novice need to know about running, maintaining, and interpreting the results from GC Analytical chemists, technicians, and scientists in allied disciplines have come to regard Modern Practice of Gas Chomatography as the standard reference in gas chromatography. In addition to serving as an invaluable reference for the experienced practitioner, this bestselling work provides the beginner with a solid understanding of gas chromatographic theory and basic techniques.This new Fourth Edition incorporates the most recent developments in the field, including entirely new chapters on gas chromatography/mass spectrometry (GC/MS); optimization of separations and computer assistance; high speed or fast gas chromatography; mobile phase requirements: gas system requirements and sample preparation techniques; qualitative and quantitative analysis by GC; updated information on detectors; validation and QA/QC of chromatographic methods; and useful hints for good gas chromatography.As in previous editions, contributing authors have been chosen for their expertise and active participation in their respective areas. Modern Practice of Gas Chromatography, Fourth Edition presents a well-rounded and comprehensive overview of the current state of this important technology, providing a practical reference that will greatly appeal to both experienced chomatographers and novices

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Handbook of Pharmaceutical Analysis by HPLC, Volume 6

High pressure liquid chromatography frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening,* A complete reference guide to HPLC* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

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