Gareth Thomas, "Medicinal Chemistry: An Introduction"

Medicinal Chemistry: An Introduction, Second Edition provides a comprehensive, balanced introduction to this evolving and multidisciplinary area of research. Building on the success of the First Edition, this edition has been completely revised and updated to include the latest developments in the field.

Written in an accessible style, Medicinal Chemistry: An Introduction, Second Edition carefully explains fundamental principles, assuming little in the way of prior knowledge. The book focuses on the chemical principles used for drug discovery and design covering physiology and biology where relevant. It opens with a broad overview of the subject with subsequent chapters examining topics in greater depth.

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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives. 

The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices.

With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.

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Progress in Inorganic Chemistry, Dithiolene Chemistry: Synthesis, Properties, and Applications

"Dithiolene metal complexes have a history going back to the 1960's (at least). But, interest in such compounds faded by the seventies. However, there has been a major resurgence, just in the last very few years, and a number of research groups have found exciting new properties (i.e., photochemistry, luminescence), applications as sensors and new materials of industrial interest. 

Moreover, very recent (in the last five years, or less) biochemical insights have revealed that dithiolene-metal complexes exist in nature, in certain enzyme active sites. Thus, a segment of the biochemical and (bio)inorganic chem istry community is currently devoting considerable attention to inorganic synthetic, theoretical and other aspects of dithiolene coordination chemistry."

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The Design and Manufacture of Medical Devices

Medical devices are included in the fields of medical and health technology and encompass a wide range of health care products. Today, it is difficult to obtain an exact definition of "medical device." Directive 2007/47/EC, for example, defines a medical device as, "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings." 

This book brings together a range of articles and case studies dealing with medical device R&D. Chapters cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems.

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Melloni's Pocket Medical Dictionary: Illustrated

The Melloni series of medical dictionaries are famous for their concise definitions and detailed illustrations. And Melloni's Pocket Medical Dictionary: Illustrated is no exception. A condensed and portable version of the award-winning and highly acclaimed Mellonis's Illustrated Medical Dictionary, the book features a wide range of beautifully drawn and carefully labeled illustrations to accompany the large number of expert and concise medical definitions. The pocketbook takes the most important qualities of the 4th Edition, reduces its size without sacrificing accuracy and clarity, and adds the most current information. When you can't take the big book with you, this book provides the information you need where you need it.

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Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals) by WHO

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel.

Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.

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National Formulary of India (NFI 2011, 4th Edition)

The National Formulary of India is essentially meant for the guidance of the members of the medical profession; medical students, nurses and pharmacists working in hospitals and in sales establishments. In the preparation of this Formulary, the expert opinion of medical practitioners, teachers in medicine, nurses, pharmacists and Pharmaceutical manufacturers has been obtained. The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country. Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy.

As more than three decades have elapsed since the publication of the last edition of the National Formulary of India, it is to be expected that This 4th edition of NFI would have many distinct features to promote the rational use of medicines in the country.

The formulations included in the Formulary and the ingredients thereof should conform to the standards laid down in the current edition of the Indian Pharmacopoeia. If no standards are specified in the current edition but are specified in the immediately preceding edition of the Indian Pharmacopoeia then these standards would apply. In respect of drugs for which no standards have been laid down in the Indian Pharmacopoeia, these would have to conform to the standards laid down in the official pharmacopoeia of any other country wherein they are included. The provisions of the Drugs and Cosmetics Act and the Rules made thereunder including those relating to labeling and conditions of storage should be observed.

Contents: Preface.  Acknowledgements. 1. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDS). 2. Antacids and antiulcer Drugs. 3. Antiallergics and drugs used in anaphylaxis. 4. Anti-Alzheimer and anti-parkinsonism drugs. 5. Anticonvulsants/antiepileptics. 6. Antidiarrhoeals and laxatives. 7. Antidotes and substances used in poisoning. 8. Antiemetics. 9. Anti-infectives. 10. Antimigraine drugs. 11. Antineoplastics and immunosuppressives. 12. Antiseptics and disinfectants. 13. Cardiovascular drugs. 14. Dermatological drugs. 15. Diagnostic agents. 16. Dialysis fluids. 17. Disease modifying anti-rheumatic drugs (DMARDs) and Drugs for Gout. 18. Diuretics. 19. Drugs in Osteoporosis. 20. Drugs for anaesthesia. 21. Drugs for inflammatory Bowel disease. 22. Drugs for Myasthenia Gravis. 23. Drugs for respiratory diseases. 24. Hormones, contraceptives and related drugs. 25. Immunologicals. 26. Muscle relaxants. 27. Ophthalmological preparations. 28. Psychotherapeutic drugs. 29. Solutions correcting water, electrolyte and acid base disturbances. 30. Vitamins, minerals and antianaemic drugs. Appendices. Index.

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