Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins

 Pharmacology  Comments Off on Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins
Mar 062019
 

Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases

With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed.

Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include:

• Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins

• Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins)

• Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus

Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.

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Plant and Human Health, Volume 3: Pharmacology and Therapeutic Uses

 Pharmacology  Comments Off on Plant and Human Health, Volume 3: Pharmacology and Therapeutic Uses
Feb 282019
 

Early anthropological evidence for plant use as medicine is 60,000 years old as reported from the Neanderthal grave in Iraq. The importance of plants as medicine is further supported by archeological evidence from Asia and the Middle East. Today, around 1.4 billion people in South Asia alone have no access to modern health care, and rely instead on traditional medicine to alleviate various symptoms. On a global basis, approximately 50 to 80 thousand plant species are used either natively or as pharmaceutical derivatives for life-threatening conditions that include diabetes, hypertension and cancers. As the demand for plant-based medicine rises, there is an unmet need to investigate the quality, safety and efficacy of these herbals by the “scientific methods”. Current research on drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, analytical, and molecular techniques. For instance, high throughput robotic screens have been developed by industry; it is now possible to carry out 50,000 tests per day in the search for compounds which act on a key enzyme or a subset of receptors. This and other bioassays thus offer hope that one may eventually identify compounds for treating a variety of diseases or conditions. However, drug development from natural products is not without its problems. Frequent challenges encountered include the procurement of raw materials, the selection and implementation of appropriate high-throughput bioassays, and the scaling-up of preparative procedures.

Research scientists should therefore arm themselves with the right tools and knowledge in order to harness the vast potentials of plant-based therapeutics. The main objective of Plant and Human Health is to serve as a comprehensive guide for this endeavor. Volume 1 highlights how humans from specific areas or cultures use indigenous plants. Despite technological developments, herbal drugs still occupy a preferential place in a majority of the population in the third world and have slowly taken roots as alternative medicine in the West. The integration of modern science with traditional uses of herbal drugs is important for our understanding of this ethnobotanical relationship. Volume 2 deals with the phytochemical and molecular characterization of herbal medicine. Specifically, it will focus on the secondary metabolic compounds which afford protection against diseases. Lastly, Volume 3 focuses on the physiological mechanisms by which the active ingredients of medicinal plants serve to improve human health. Together this three-volume collection intends to bridge the gap for herbalists, traditional and modern medical practitioners, and students and researchers in botany and horticulture.

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Communication in Pharmacy Practice

 Pharmacology  Comments Off on Communication in Pharmacy Practice
Feb 172019
 


This reprint book ‘Communication in Pharmacy Practice’ is launched to help improve communication practices by increasing knowledge of different aspects of communication in pharmacy practice. The book consists of recently published research articles and illustrates that pharmacy communication is a research subject that is investigated globally and from many perspectives.
The overall pharmacy communicational themes investigated and discussed in this book are as follows: Communication between health care professionals; communication between pharmacists and patients in the context of both prescription and over-the-counter (OTC) medicines; and factors impacting communication. There are many challenges for communication in pharmacy practice today, and several are highlighted in this book.
A central conclusion to the research contributions of several of the authors is the specific need to further develop direct, face-to-face communication between pharmacy staff and patients/consumers including tools to better address patient’s needs.

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Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachabl

 Pharmacology  Comments Off on Compatibility of Pharmaceutical Products and Contact Materials: Safety Considerations Associated with Extractables and Leachabl
Feb 112019
 

 

Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of “what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?” and “when do the various required activities need to be performed?” Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book’s appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.Content: Chapter 1 Introduction (pages 1–26): Chapter 2 Nomenclature and General Concepts (pages 27–75): Chapter 3 Extractables, Leachables, and the Product Life Cycle (pages 77–88): Chapter 4 Material Screening and Characterization (pages 89–156): Chapter 5 The Prototype Stage (pages 157–190): Chapter 6 The Early Development Stage (pages 191–228): Chapter 7 Late Stage Product Development (pages 229–247): Chapter 8 Submission (pages 249–263): Chapter 9 Launch (pages 265–269): Chapter 10 Product Maintenance (pages 271–313): Chapter 11 Retirement (pages 315–317): Chapter 12 Focus on Emerging Concepts (pages 319–346):
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Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach

 Pharmacology  Comments Off on Safety Evaluation of Biotechnologically-derived Pharmaceuticals: Facilitating a Scientific Approach
Feb 112019
 

Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products’, which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.
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Pharmacology of Endogenous Neurotoxins: A Handbook

 Neurology/Neurosurgery, Pharmacology  Comments Off on Pharmacology of Endogenous Neurotoxins: A Handbook
Feb 112019
 

It is a great pleasure to write the foreword to this important volume for several reasons. First: As far as we know, already primitive societies had to cope with environmental toxins of many kinds and set up regulations to limit their effects on food and drug use. Modem science, synthesizing tens of millions of new compounds has incredibly magnified this challenge. Today, xenobiotic metabolism has become a crucial task for humans and many other species alike. Second: When reading this book, one is impressed by the extraordinary speed at which neurotoxicology has advanced. Obviously, processing (and endogenous formation) oftox­ ins has become an extremely relevant topic. When I had the chance, almost three decades ago, to work in chemical pharmacology with Bernard B. Brodie at NIH, the drug metabo­ lizing system of the liver had just been recognized and characterized. We had just started to work on the biogenic amines, newly discovered cyclic nucleotides in rat brain, human cere­ brospinal fluid, and on the effects of toxic drugs like amphetamines. Today, biochemical neuropharmacology is a mature field of neuroscience.
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Evaluating Pharmaceuticals for Health Policy and Reimbursement

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Feb 082019
 

“The challenge in all settings is to make the difficult decisions in a way that is defensible, justifiable, ethical, and equitable”So write Nick Freemantle and Suzanne Hill in their introduction to this important discussion on decision making in the reimbursement of pharmaceuticals. Based around a programme supported by the World Health Organization, chapters by leading academics involved in the research tackle such major issues as international pharmaceutical policy, tensions in licensing policies, priority setting, and relationships between the stakeholders.Chapters includeDevelopment of marketing authorisation procedures for pharmaceuticalsInterpreting clinical evidenceInternational pharmaceutical policy: health creation or wealth creation?Development of fourth hurdle policies around the worldEconomic modelling in drug reimbursementPriority setting in health care: matching decision criteria with policy objectivesTensions in licensing and reimbursement decisions: case of riluzole for amytrophic lateral sclerosisRelationship between stakeholders: managing the war of wordsMedicine and the media: good information or misleading hype?How to promote quality use of cost-effective medicines Using economic evaluation to inform health policy and reimbursement: making it happen and making it sustainablePricing of pharmaceuticalsEvaluating pharmaceuticals for health policy in low and middle income country settings.Besides the controversial issues there is a wealth of practical information including economic modelling and the experiences from the WHO programme, providing readers with workable examples. This is essential reading for clinical researchers in pharmaceuticals and policy makers everywhere.Content: Chapter 1 Introduction (page 0): Nick Freemantle and Suzanne HillChapter 2 Development of Marketing Authorisation Procedures for Pharmaceuticals (pages 3–23): Alar Irs, Truus Janse de Hoog and Lembit RagoChapter 3 Interpreting Clinical Evidence (pages 24–45): Nick Freemantle, Joanne Eastaugh, Melanie Calvert, Suzanne Hill and Jesse BerlinChapter 4 International Pharmaceutical Policy: Health Creation or Wealth Creation? (pages 46–66): Karen Bloor and Alan MaynardChapter 5 Development of Fourth Hurdle Policies Around the World (pages 67–87): Rod S Taylor, Mike F Drummond, Glen Salkeld and Sean D SullivanChapter 6 Economic Modelling in Drug Reimbursement (pages 88–104): Glenn Salkeld, Nick Freemantle and Bernie O’BrienChapter 7 Priority Setting in Health Care:Matching Decision Criteria with Policy Objectives (pages 105–120): Gina Brinsmead and Alan WilliamsChapter 8 Tensions in Licensing and Reimbursement Decisions: The Case of Riluzole for Amytrophic Lateral Sclerosis (pages 121–138): Stirling Bryan, Josie Sandercock, Pelham Barton and Amanda BurlsChapter 9 Relationships Between Stakeholders: Managing the War of Words (pages 139–156): Suzanne Hill and Kees de JoncheereChapter 10 Medicine and the Media: Good Information or Misleading Hype? (pages 157–173): Moynihan Ray, Lisa M Schwartz and Steven WoloshinChapter 11 How to Promote Quality Use of Cost?Effective Medicines (pages 174–189): Hans Hogerzeil and Kathleen HollowayChapter 12 Using Economic Evaluation to Inform Health Policy and Reimbursement: Making it Happen and Making it Sustainable (pages 190–207): Andrew MitchellChapter 13 Pricing of Pharmaceuticals (pages 208–226): David Newby, Andrew Creese and Alan StevensChapter 14 Evaluating Pharmaceuticals for Health Policy in Low and Middle Income Country Settings (pages 227–243): Andrew Creese, Anita Kotwani, Joseph Kutzin and Anban Pillay

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Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

 Pharmacology  Comments Off on Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries
Feb 052019
 

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.Content: Chapter 1 A Review of Project Management in Life Science Industry Sectors (pages 3–19): Thomas R. DunsonChapter 2 The Impact of Organizational Size on Drug Project Management (pages 21–32): Eric MorfinChapter 3 Drug Development in Biotechnology and How We Can Do It Better (pages 33–47): Susan LinnaChapter 4 An Overview of the Organization and Processes of Portfolio, Program, and Project Management (pages 53–57): Pete HarpumChapter 5 Portfolio Management in the Pharmaceutical Industry: Balancing Corporate Need with the Reality of Delivering Products to the Market (pages 59–83): Dr. John BennettChapter 6 Program Management in Drug Development (pages 85–99): Pauline Stewart?LongChapter 7 Project Control (pages 101–134): Martin PowellChapter 8 Managing Uncertainty in Drug Projects (pages 135–153): Pete Harpum and Thomas R. DunsonChapter 9 Managing Drug Safety Risk (pages 155–174): Thomas R. Dunson and Eric MorfinChapter 10 Developing Program Strategy (pages 175–196): Pete HarpumChapter 11 Developing Products with “Added Value” (pages 197–224): Trevor J. Brown and Stephen AllportChapter 12 Integrated Business Processes to Support Cross?Functional Drug Development (pages 227–238): Martin D. HynesChapter 13 Integrated Drug Development: From Cradle to Grave and from Lab to Market (pages 239–258): Stephen Allport and Terry Cooke?DaviesChapter 14 The Development of P3M Capability in Drug Development Organizations (pages 259–285): John Arrowsmith, Patrick Grogan and Bob MooreChapter 15 Implementing Portfolio, Program, and Project Management Best Practices in Drug Development Organizations (pages 287–309): Pete Harpum, Ashley Jamieson and Inge Fisher
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Pharmaceutical Bioassays: Methods and Applications

 Pharmacology  Comments Off on Pharmaceutical Bioassays: Methods and Applications
Feb 052019
 

The definitive compendium of bioassay procedures and applications A virtual encyclopedia of key bioassay protocols, this up-to-date, essential resource reviews the methods and applications of bioassays that quantify drug activity and evaluate the validity of pharmacological models. Demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules, the book covers the evaluation and screening of drug compounds in a wide spectrum of therapeutic categories. Throughout, the authors use various models to link experimental observations with findings that clarify the effect of drug compounds on cellular biology and measure the pharmacological activity of chemical substances. This provides an important technological platform for successful drug research and clinical therapy, making Pharmaceutical Bioassays an ideal sourcebook for pharmacologists, pharmaceutical and medical researchers, analytical chemists, toxicologists, and students. Just as a fundamental knowledge of pharmaceutical bioassays is vital to understanding how bioactive agents and new drugs are defined, discovered, and developed, so too is this indispensable reference, which: Offers a complete reference on pharmaceutical bioassays and their specific applications in the assessment of therapies for cancer, Alzheimer’s, diabetes, epilepsy, inflammation, antimalarials, pharmacogenomics, and other major therapeutic areas Covers bioassays that measure toxicity, including those for chemical toxicity and hepatoxicity—a particularly significant consideration in the development of safe and tolerable medications Highlights clinically relevant methods, ideas, and techniques to support any pharmaceutical researcher Suggests guidelines and systems to enhance communication between pharmacologists, chemists, and biologists Provides an informative analysis of pharmaceutical bioassay technologies and lab applications Content: Chapter 1 Methods and Applications of Anticancer Bioassays (pages 1–21): Shiqi PengChapter 2 Methods and Applications of Antiviral Assays (pages 23–37): Shiqi Peng, Ming Zhao and Chunying CuiChapter 3 Methods and Applications of Antitubercular Assays (pages 39–44): Shiqi Peng, Ming Zhao and Chunying CuiChapter 4 Methods and Applications of Thrombus?Related Assays (pages 45–64): Ming ZhaoChapter 5 Methods and Applications of Anticoagulation Assays (pages 65–86): Ming ZhaoChapter 6 Methods and Applications of Blood Pressure?Related Assays (pages 87–100): Ming ZhaoChapter 7 Methods and Applications of Assays Related to Parkinson’s Disease and Graves’ Disease (pages 101–123): Shiqi PengChapter 8 Methods and Applications of Alzheimer’s Disease Assays (pages 125–144): Shiqi PengChapter 9 Methods and Applications of Antiosteoporosis Assays (pages 145–156): Ming ZhaoChapter 10 Methods and Applications of Immunomodulating Assays (pages 157–185): Shiqi PengChapter 11 Methods and Applications of Anti?Inflammatory Assays (pages 187–204): Ming ZhaoChapter 12 Methods and Applications of Antioxidant Activity Assays (pages 205–221): Shiqi PengChapter 13 Methods and Applications of Analgesic Assays (pages 223–236): Ming ZhaoChapter 14 Methods and Applications of Epilepsy Assays (pages 237–249): Ming Zhao, Shiqi Peng and Guohui CuiChapter 15 Methods and Applications of Diabetes Assays (pages 251–258): Ming Zhao, Shiqi Peng and Guohui CuiChapter 16 Methods and Applications of Assays for Toxins from Microorganisms (pages 259–280): Shiqi PengChapter 17 Methods and Applications of Toxicity Assays for Chemicals (pages 281–323): Shiqi PengChapter 18 Methods and Applications of Hepatoxicity and Hepatoprotective Assays (pages 325–372): Shiqi PengChapter 19 Methods and Applications of Estrogen Assays (pages 373–395): Shiqi PengChapter 20 Methods and Applications of Antimalarial Assays (pages 397–417): Shiqi PengChapter 21 Methods and Applications of Cytogenetic Receptor and Enzyme Assays (pages 419–443): Shiqi Peng
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Pharmacy Law and Practice, Third Edition

 Pharmacology  Comments Off on Pharmacy Law and Practice, Third Edition
Feb 052019
 

This textbook explains what pharmacy students and practicing pharmacists need to know about pharmacy and the law, including recent changes in the National Health Service. The book provides easy accessibility amd concise, yet comprehensive information. There have been many changes in the NHS and in the law relating to pharmacy since the first edition was written. Therefore, the book has been thoroughly revised, and the text re-organized. Content: Chapter 1 The National Health Service (pages 1–13): Chapter 2 Administration of the NHS (pages 14–23): Chapter 3 Applications to Dispense NHS Prescriptions (pages 24–32): Chapter 4 Rural Dispensing (pages 33–37): Chapter 5 Terms of Service (pages 38–53): Chapter 6 The Drug Tariff (pages 54–65): Chapter 7 Prescription Charges (pages 66–72): Chapter 8 Complaints and Discipline in the NHS (pages 73–82): Chapter 9 Retail Pharmacy (pages 83–88): Chapter 10 Manufacture and Licensing of Medicinal Products (pages 89–98): Chapter 11 Control of Sales of Medicines (pages 99–117): Chapter 12 Special Circumstances (pages 118–124): Chapter 13 Hospitals and the Medicines Act (pages 125–127): Chapter 14 Traditional and Alternative Medicines (pages 128–136): Chapter 15 Labelling and Containers (pages 137–148): Chapter 16 Other Health Professions and Medicines (pages 149–159): Chapter 17 Poisons and Other Controls (pages 160–167): Chapter 18 Controlled Drugs (pages 168–188): Chapter 19 Confidentiality and Records (pages 189–197): Chapter 20 The European Union (pages 198–203): Chapter 21 The Pharmacy Profession (pages 204–219): Chapter 22 Liability in Negligence (pages 220–227): Chapter 23 Business Premises (pages 228–243): Chapter 24 Business Associations (pages 244–260): Chapter 25 The Sale of Goods (pages 261–283): Chapter 26 Employment Law (pages 284–312):
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