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Pharmaceutical Quality by Design: A Practical Approach

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Jan 282018

A practical guide to Quality by Design for pharmaceutical product development

Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product.

Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource:

Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development
Puts the focus on the industrial aspects of the new QbD approach
Includes several illustrative examples of applications of QbD in practice
Offers advanced specialist topics that can be systematically applied to industry
Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

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http://nitroflare.com/view/03943101C43B042/1118895207.pdf

Anticancer Therapeutics: From Drug Discovery to Clinical Applications

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Jan 272018

An integrated presentation of the basic science and clinical applications of anticancer agents

Aimed at both undergraduate and postgraduate readers, this unique text provides readers with a fully-integrated presentation of all aspects of the science of anticancer drugs, including their chemistry, pharmacology, and clinical applications.

After heart disease, cancer is the number one killer worldwide, and the tumor microenvironment is forever changing, creating an ever-greater demand for safer, more effective anticancer agents. In response to that demand, the $100 billion cancer drug market continues to grow, with our increased understanding of cancer leading to new drugs being used clinically almost every year.

Anticancer Therapeutics is divided into three sections. Section 1 is an introduction to cancer and therapeutics, and covers the etiology and cellular and molecular basis of cancer. In Section 2, the authors focus on the anticancer agents — their discovery, synthesis, mode of action, mechanisms of resistance, and adverse reactions. Section 3 focuses on specific cancers, explaining how and why the various agents discussed in Section 2 are used, both individually and in combination, to treat different cancers.

Integrates aspects of basic science, including chemistry and pharmacology and clinical medicine in relation to cancer therapeutics
Written by an author team comprising specialists in medicinal chemistry, pharmacology, and oncology
Features full-color images throughout illustrating how drugs bind to cellular targets and exert their pharmacological effect
Divided into three sections, covering the etiology and cellular and molecular basis of cancer, anticancer agents, and drug applications for different cancers.
Providing the reader with an integrated understanding of all aspects of the science of anticancer agents, this is an ideal textbook for undergraduates studying medicine, nursing, medicinal chemistry, pharmacy, pharmacology and other allied heath / life sciences. It is also a valuable bench reference for pharmacists, medics, and pharmaceutical researchers working in both academia and industry.

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http://nitroflare.com/view/5429C4AF5310CDA/111862212X.pdf

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

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Jan 262018

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.
Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

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http://nitroflare.com/view/921D9D701B8DE8E/Medical_Product_Regulatory_Affairs_Pharmaceuticals%2C_Diagnos.pdf