Principles and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.
*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine.
*Expert authorship whose experience includes running clinical trials in an academic as well as industry settings.
*Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.

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Pharmaceutical Technology. Controlled Drug Release, Volume 2

Extends the concepts of Volume 1 to include drug properties, design and optimization, coating and the effect of food and pharmacokinetics. This volume also reflects the growing interest in biodegradable polymers in oral and topical formulations.

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British National Formulary 56

Compiled with the advice of clinical experts, the British National Formulary (BNF) provides up-to-date guidance on prescribing, dispensing and administering medicines.

The BNF details medicines prescribed in the UK, with special reference to their uses, cautions, contra-indications, side-effects, dosage and relative costs.

Updated every six months, the BNF reflects current best practice as well as legal and professional guidelines relating to the use of medicines. It is intended for use by prescribers, pharmacists and other healthcare professionals.

• Designed for rapid reference
• Authoritative, impartial and, where available, evidence-based advice on prescribing, dispensing and administering medicines
• Updated twice a year to reflect promptly changes in product availability as well as emerging safety concerns and shifts in clinical practice

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Pharmaceutical Design And Development: A Molecular Biology Approach

This volume aims to introduce researchers in pharmaceutical and allied industries to the concepts and latest developments in the application of biotechnology recombinant DNA and monoclonal antibodies to drug development. The author puts biotechnology in perspective, introducing the basic concepts of cell and molecular biology and discussing both the application of protein drugs and the design of new molecular entities. The study examines the use of proteins and assay systems produced via biotechnology to the development of small-molecule drugs. A discussion of gene and somatic cell therapies is included, along with developments in diagnostic methods resulting from biotechnology. The text concludes by examining future prospects and likely developments in the field.

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Managing Pharmacy Practice: Principles, Strategies, and Systems

The myriad changes in health care and health care delivery have transformed the pharmacist's role within those systems. Reflecting these changes, Managing Pharmacy Practice: Principles, Strategies, and Systems delineates the managerial issues pharmacists face today and those that they will face in the future. Highlighting the growing impact of technology throughout pharmacy and healthcare, the book underlines the challenges of this rapidly evolving profession and explores strategies for success. Touching on basic management theory and thoroughly discussing systems theory, the text supplies the groundwork for analyzing managerial systems. This systems approach will allow the reader to understand the contextual relationships between seemingly disparate concepts. For example, the discussion of professionals and their role in society is juxtaposed with discussions of organizational designs and power. With contributions from leaders in fields as diverse as pharmacy, human resources, education, and management writing about their experiences, the book presents a broad overview of the complexities and intricacies inherent in managing systems in pharmacy.

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Microbiological Assay for Pharmaceutical Analysis: A Rational Approach

A user-friendly guide for the evaluation of microbiological assays, Microbiological Assay for Pharmaceutical Analysis: A Rational Approach provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. Beginning with a review of the theoretical basis for the quantitative aspects, the author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist. The book contains detailed evaluations of assays that illustrate typical experimental designs and addresses how to present a realistic assessment of the best potency estimate from a series of assays. Although there are other valuable books available in this area, they do not address evaluation. Microbiological Assay for Pharmaceutical Analysis: A Rational Approach expands on the guidance given in pharmacopoeias and helps you choose the assay design most appropriate for the purpose of your assay.

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Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.

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