Nov 192017
 

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals


By (author): John Geigert

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today’s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
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Nov 162017
 

FASTtrack: Managing Symptoms in the Pharmacy


By (author): Mr Alan Nathan

This is a revision guide for students giving bullet points of basic information on managing symptoms in the pharmacy.”Fast Track” is a new series of indispensable revision guides created especially for undergraduate pharmacy students.The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples.”The Fast Track” series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams.Covering all common ailments, organized by system in alphabetical order, this book provides all the essential information needed for managing symptoms presented in the pharmacy.A Fast Track website will also be live at time of publication and will include MCQs, and samples.
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Nov 152017
 

LWW’s Foundations in Sterile Products for Pharmacy Technicians (LWW’s Foundations Series)


Features: Used Book in Good Condition
By (author): W. Renee Acosta RPh MS

Designed specifically for pharmacy technician students, LWW’s Foundations in Sterile Products for Pharmacy Technicians is the comprehensive resource for understanding the role of sterile products in a pharmacy setting. Successful pharmacy technicians must follow USP 797 regulations on sterile products and aseptic technique; this textbook is the comprehensive resource to guarantee a working understanding of these regulations. Designed to be concise and accessible, students using this text will be knowledgeable, confident, and prepared for professional success.

A comprehensive supplement package includes an electronic Quiz Bank and full text online. Pharmacy technician program instructors can access PowerPoint Presentations, an Image Bank, and a Brownstone Test Generator online at thePoint™.

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Nov 132017
 

Electroanalysis in Biomedical and Pharmaceutical Sciences: Voltammetry, Amperometry, Biosensors, Applications (Monographs in Electrochemistry)


By (author): Sibel A. Ozkan, Jean-Michel Kauffmann, Petr Zuman

Through this monograph, the pharmaceutical chemist gets familiar with the possibilities electroanalytical methods offer for validated analyses of drug compounds and pharmaceuticals. The presentation focuses on the techniques most frequently used in practical applications, particularly voltammetry and polarography. The authors present the information in such a way that the reader can judge whether the application of such techniques offers advantages for solving a particular analytical problem. Basics of individual electroanalytical techniques are outlined using as simple language as possible, with a minimum of mathematical apparatus. For each electroanalytical technique, the physical and chemical processes as well as the instrumentation are described. The authors also cover procedures for the identification of electroactive groups and the chemical and electrochemical processes involved.

Understanding the principles of such processes is essential for finding optimum analytical conditions in the most reliable way. Added to this is the validation of such analytical procedures. A particularly valuable feature of this book are extensive tables listing numerous validated examples of practical applications. Various Indices according to the drug type, the electroactive group and the type of method as well as a subject and author index are also provided for easy reference.

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Nov 122017
 

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics (Cancer Drug Discovery and Development)


There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer.

Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs.

  • Road map to anticancer drug development from discovery to NDA submission
  • Discussion of molecular targets and preclinical screening
  • Development and validation of bioanalytical methods
  • Chapters on clinical trial design and phase 0, I, II, III clinical trials
  • Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents
  • Review of the drug development process from both laboratory and clinical perspectives
  • New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development
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Nov 112017
 

Severe Asthma: Toward Personalized Patient Management


This book presents state of the art knowledge on severe asthma with the aim of providing readers with a clear understanding of, first, the heterogeneity of the condition and of patients’ symptom profiles and responses to therapy and, second, the future implications of this heterogeneity for individualized patient care. After an opening section that offers an overview of severe asthma, including its clinical significance, the pathogenesis, available diagnostic approaches, and treatment options are described in detail. The sections on diagnosis and treatment cover the role of biomarkers, the use of radiologic diagnostic modalities, and both pharmacologic and non-pharmacologic therapies, including emerging options that will address hitherto unmet needs of patients. The outcomes of cutting-edge preclinical and clinical research are carefully documented and numerous useful tips provided on patient management. The inclusion of many informative schematic figures will assist readers in grasping the contents easily. The book will be of high value for medical students, researchers, general physicians, specialists, and paramedical staff.

List Price: $109.00 USD
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Nov 112017
 

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Nov 112017
 

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Nov 052017
 

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Nov 052017
 

Drug Therapy for Stroke Prevention


Stroke is the third leading cause of death in the USA and UK. It is a major cause of disability among adults and is a significant factor in dementia in later life and its incidence is on the rise. This book discusses specific medications that target the blood and vasculature and how these treatments can be used to complement other therapeutic measures, such as carotid endarterectomy. It covers the pharmacological methods used to address the risk factors in stroke, the major drug discoveries of recent years–antiaggregant, antithrombotic, and anticoagulant therapies–and also long established therapies such as aspirin and warfarin. With contributions by internationally recognized experts, this is a unique single source of information on current pharmacological prevention of stroke.
List Price: $194.95 USD
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