The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

This volume addresses one of the Holy Grails in Psychiatry, namely the evidence for and potential to adopt 'Biomarkers' for prevention, diagnosis, and treatment responses in mental health conditions. It meshes together state of the art research from international renowned pre-clinical and clinical scientists to illustrate how the fields of anxiety disorders, depression, psychotic disorders, and autism spectrum disorder have advanced in recent years.

In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely - to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist's point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.

This thorough volume delves into antiepileptic drug discovery with a comprehensive collection of innovative approaches for the development of antiepileptic therapies, focusing on novel molecular targets for antiepileptic drugs, computer-aided approaches for the identification of new drug candidates, and therapeutic strategies to overcome refractory epilepsy. The last section illustrates the potential benefits that network pharmacology and rational drug repurposing could bring to the antiepileptic drug discovery community. Written for the Methods in Pharmacology and Toxicology series, chapters include the kind of detailed description and implementation advice to ensure results in the laboratory. Authoritative and practical, Antiepileptic Drug Discovery: Novel Approaches aims to provide medicinal chemists, pharmacologists, and other researchers with the tools need to further explore the study of pharmacoresistant epilepsy and the discovery of new antiepileptic drugs.

A concise, accessible account of pharmacology, covering all the key concepts you need with no gaps. It can be used either as an introduction to a topic, or as a revision aid. Big Picture Section - you can relate detail to the subject as a whole High Return Facts - fills large gaps in your knowledge. Can be used as a revision tool. Reinforces the major points Cartoon-strip illustrations - you can visualise difficult concepts in a step-by-step format - information is chunked into 'student-friendly' sizes Double-page overviews - read topic summaries without cross-referencing to other pages - they're all laid out in one spread!

Written by experts in the field, this comprehensive resource offers valuable information on the practical uses of drugs in primary eye care. Discussions of the pharmacology of ocular drugs such as anti-infective agents, anti-glaucoma drugs, and anti-allergy drugs lead to more in-depth information on ocular drugs used to treat a variety of disorders, including diseases of the eyelids, corneal diseases, ocular infections, and glaucoma. The book also covers ocular toxicology, focusing on drug interactions, ocular effects of systemic drugs, and life-threatening systemic emergencies. A logical organization makes it easy to find essential information. Complete coverage of the basic fundamentals of pharmacology such as ocular drug delivery and ocular drug formulations. Comprehensive reviews of the pharmacology of specific classes of agents such as the cycloplegics, antiglaucoma drugs, anti-inflammatory drugs, ocular irrigating solutions, and contact lens care products. In-depth information on ocular drugs used in clinical practice, including chapters on drugs used to treat eyelid disorders, lacrimal diseases, conjunctiva diseases, corneal diseases, allergies, uveitis, postoperative cataract, retinal diseases, and glaucoma. Coverage of ocular toxicology, including drug interactions, ocular effects of systemic drugs, and life-threatening systemic emergencies. Completely revised and updated content that reflects the latest advances in pharmacology. Updated information on post-operative drugs, including LASIK follow up medications. Expanded coverage in the chapters on Anti-infective Drugs, Anti-allergy Drugs and Decongestants, and Lubricants and Other Preparations of Ocular Surface Disease that includes the latest advancements in antibiotics and medications used to treat allergies and dry eye. A dosage quick reference guide on the inside front cover for quick and easy access. Information on the use of herbal medications.

Although it is one of the most-widely studied viruses, many mysteries still remain about HIV. Covering the latest advances and challenges associated with clinical application of new antiviral drugs and vaccines, this revised edition is a companion to Murad: "HIV-1: Molecular Biology and Pathogenesis, 2E." Leading investigators in HIV research present a timely picture of the molecular mechanisms which guide HIV-1 expression and replication and provide the most current clinical strategies for combating this virus.
* The latest developments in HIV-vaccine research
* New concepts in the discovery and design of novel anti-HIV drugs

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: * Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies * Authors from different major pharmaceutical and biotechnology companies * Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Reports on the emergence and prevalence of resistant bacterial infections in hospitals and communities raise concerns that we may soon no longer be able to rely on antibiotics as a way to control infectious diseases. Effective medical care would require the constant introduction of novel antibiotics to keep up in the "arms race" with resistant pathogens. This book closely examines the latest developments in the field of antibacterial research and development. It starts with an overview of the growing prevalence of resistant Gram-positive and Gram- negative pathogens, including their various resistance mechanisms, prevalence, risk factors and therapeutic options. The focus then shifts to a comprehensive description of all major chemical classes with antibacterial properties, their chemistry, mode of action, and the generation of analogs; information that provides the basis for the design of improved molecules to defeat microbial infections and combat the emerging resistances. In closing, recently developed compounds already in clinical use, those in preclinical or first clinical studies, and a number of promising targets to be exploited in the discovery stage are discussed.

This volume will address an important emergent area within the field of immunomics: the discovery of antigens and adjuvants within the context of reverse vaccinology. Conventional approaches to vaccine design and development requires pathogens to be cultivated in the laboratory and the immunogenic molecules within them to be identifiable. Conventional vaccinology is no longer universally successful, particularly for recalcitrant pathogens. By using genomic information we can study vaccine development in silico: 'reverse vaccinology', can identify candidate subunits vaccines by identifying antigenic proteins and by using equally rational approaches to identify novel immune response-enhancing adjuvants.

This book covers research studies of aloe by the CAP (Creation Aloe Pharmaceuticals) team. It details the various physiological effects of those components for possible use as health foods or drugs. The team was organized into the isolation and analysis group, which purified many components in terms of low molecular weight compounds, carbohydrates, proteins present in aloe, and the assay group, which determined the efficacy of those components.

Spanning from discoveries in fundamental immunology to industrial and commercial concerns, the study of vaccine adjuvants has developed into an exciting area of work with great, vital potential in innovating techniques in which adjuvants may steer the immune system towards the responses required by unmet vaccination needs. In Vaccine Adjuvants: Methods and Protocols, expert researchers in the field provide clear and concise guidance on how to go about assessing the activity of adjuvant products. Rather than describing individual adjuvants, the volume strives to include detailed, practical information on measuring the responses produced by adjuvants in order to be relevant to the widest array of experiments. Written in the highly successful Methods in Molecular Biology (TM) series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and versatile, Vaccine Adjuvants: Methods and Protocols will enable those already pursuing vaccine adjuvant research, while also serving to stimulate discussion on how to best standardize adjuvant testing in order to facilitate meaningful comparisons, and above all, to aid in the prediction of which new products will most effectively and safely help to solve the current challenges in vaccination.

The emergence of H5N1 avian influenza in 1997 and of the influenza A H1N1 of swine origin in 2009 calls for new, rapid and sustainable solutions for both seasonal and pandemic influenza viruses. During the last ten years, science and technology have made enormous progress, and we are now able to monitor in real time the genetics of viruses while they spread globally, to make more powerful vaccines using novel adjuvants, and to generate viruses in the laboratory using reverse genetics. This volume not only provides state-of-the-art information on the biology of influenza viruses and on influenza vaccines, but is also designed to be a resource to face the present H1N1 pandemic and to plan for long-term global and sustainable solutions.

This accessible, easy-to-read book provides readers with different perspectives on the subject of painkillers, examining their history, production, uses, and dangers. Many different drugs are effectively used as painkillers-substances that greatly improve the quality of life for those who suffer from temporary or recurring pain. This book presents an in-depth overview of opiates, opioids, and other painkilling substances such as non-steroidal anti-inflammatory drugs (NSAIDs) that have been in use from ancient times up to the contemporary era. It also addresses the risks of painkiller use, their misuse, and potential overdose concerns. The latest in the Story of a Drug series and written by a subject expert who has published widely on drug use and pharmacology, this book presents a brief review of the science of how different painkiller drugs work before covering these substances' respective effects and applications; the issues regarding the production, distribution, and regulation of painkiller drugs; and research findings on painkiller use, abuse patterns, addiction, and policy issues. The easy-to-understand text presents scientifically accurate information that enables readers to better understand the key role of painkillers in our 21st-century world. Documents the risks of painkiller use and explores the various issues centered around the production, distribution, and regulation of painkiller medications Examines painkillers from a variety of perspectives, including medical, historical, economic, and social Includes primary source documents such as guidelines, policy documents, and study findings on the topics covered that provide readers with more in-depth information and help students hone their critical thinking and analytical skills Examines the social dimensions of the use and abuse of painkiller drugs and considers the future of this particular type of drugs

This book seeks to unravel the mysteries of wolfberry, and systematically introduces its mechanisms in preventing aging-associated diseases, such as cardiovascular diseases, inflammation, liver and neurodegenerative diseases. Wolfberry, the dried fruit of Lycium barbarum, is an anti-aging herbal medicine. There have been numerous reports investigating the underlying mechanisms of its anti-aging effects and its role in preventing pathological changes in many aging-associated diseases. Its holistic effects on the body can attenuate liver toxicity and combat the spread of cancer; it also prevents degeneration in the central nervous system, and can even positively affect the skin. As such, wolfberry has become a very popular food supplement around the world. This book will serve as an excellent reference source for researchers and graduate students studying herbal medicine and aging-associated diseases, while also providing insights for the pharmaceutical industry with regard to developing potential drugs for these diseases.

Doping in sports and the fight against it has gained increasing attention in recent years. The pharmacological basis for a possible performance enhancement in competitive sport through the administration of prohibited substances and methods as well as the analytical disclosure of such practices are comprehensively covered in 21 contributions by outstanding and distinctive authors.

This book is intended as a scientific resource for cannabinoid researchers carrying out animal and human experiments, and for those who are interested in learning about future directions in cannabinoid research. Additionally, this book may be of value to investigators currently working outside the field of cannabinoid research who have an interest in learning about these compounds and their atypical cannabinoid signalling. This book provides insight into the potential medical application of cannabinoids and their therapeutic development for the treatment of human disease.

Sphingolipids are lipid components of the plasma membrane in eukaryotic cells. They have an important function in signaling mechanisms in the cell. This book on sphingolipids provides insights into the basics of sphingolipid biology and drug development, with a particular emphasis on the sphingolipid derivative ceramide. In the first part basic functions of sphingolipids are described, as well as the genetics of important enzymes, sphingolipid metabolism and synthesis. The second part of this first volume focuses on drug development and pharmacology. The book is intended for scientists in pharmacology, biochemistry and cell biology with a focus on biomedical research as well as for clinicians working in pharmacology, oncology, cardiology, neurology and infectious disease. Together with Volume 216 by the same editors, the collection represents a unique, comprehensive work on sphingolipids, providing information on both sphingolipids basic biology (including synthesis, metabolism and cell biology) and their important function in a (patho-)physiological context."

Muscarinic acetylcholine receptors have played a key role in the advancement of knowledge of pharmacology and neurotransmission since the inception of studies in these fields, and the effects of naturally occurring drugs acting on muscarinic receptors were known and exploited for both therapeutic and non-therapeutic purposes for hundreds of years before the existence of the receptors themselves was recognized. This volume presents a broad yet detailed review of current knowledge of muscarinic receptors that will be valuable both to long-time muscarinic investigators and to those new to the field. It describes the detailed insights that have been obtained on the structure, function, and cell biology of muscarinic receptors. This volume also describes physiological analyses of muscarinic receptors and their roles in regulating the function of the brain and of a variety of peripheral tissues. This volume shows how the study of muscarinic receptors continues to provide new and surprising insights not just to the cholinergic system but to the broad areas of neurobiology, cell biology, pharmacology, and therapeutics.