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The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry.
Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what “innovation” is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation.
In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders―from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective―have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices.
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data. Top biostatisticians from academia, biopharmaceutical industries, and government agencies discuss how these advances are impacting clinical trials and biomedical research.
Divided into three parts, the book begins with an overview of interval-censored data modeling, including nonparametric estimation, survival functions, regression analysis, multivariate data analysis, competing risks analysis, and other models for interval-censored data.
This work will provide a historical perspective on tumor immunotherapy, discuss fundamental mechanisms of failed tumor rejection, look at passive strategies to boost anti-tumor immunity, as well as have an in-depth look at active strategies to boost anti-tumor immunity.
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines.
This volume, new to The Receptors series, focuses on several areas, including the birth, maturation, and structure of Chemokines; Neutrophil, Dendritic, and Lymphocyte trafficking; and Chemokine Receptors in diseases such as AIDs and lung cancer. In particular the book contains cutting-edge information ranging from basic molecular and cellular mechanisms to physiological and pathological roles of chemokines.
A complete update of the highly acclaimed handbook with data on all neurotransmitters and the majority of neuromodulators. The coverage is now even more comprehensive, with 15% more entries on neuropeptides, "classic" neurotransmitters and related substances in a clear, alphabetical format. The methodological section has been expanded by 50% and now includes color figures, plus new chapters on genomics, proteomics, databases, microarrays, MALDI-TOF, neutrophins, FGF, endocannabinoids and neuroimaging.
Telomerase, an enzyme that maintains telomeres and endows eukaryotic cells with immortality, was first discovered in tetrahymena in 1985. In 1990s, it was proven that this enzyme also plays a key role in the infinite proliferation of human cancer cells. Now telomere and telomerase are widely accepted as important factors involved in cancer biology, and as promising diagnostic tools and therapeutic targets.
Editors: Zhang, Wei (Ed.)Features practical, hands-on instruction for the use of CADD systemsIncludes tips from experts in the field to ensure successful implementationFocuses on the vital early stages of the drug discovery processThis detailed volume examines computer-aided drug discovery (CADD), a crucial component of modern drug discovery programs that is widely utilized to identity and optimize bioactive compounds for the development of new drugs. With a focus on the methods that are commonly used in the early stage of drug discovery, chapters explore computer simulation, structure prediction, conformational sampling, binding site mapping, docking and scoring, in silico screening, and fragment-based drug design.
Lippincott Illustrated Reviews: Pharmacology, Sixth Edition, is the updated, enhanced version of the student-favorite resource for essentials of medical pharmacology. The first-and-best resource, the Lippincott Illustrated Reviews series features clear, effective writing and hundreds of illustrations for ideal rapid review and the assimilation of complex information. Clear, sequential images present mechanisms of action and focus on showing rather than telling students how drugs work. New edition features: All NEW chapters on Drugs of Abuse, Drugs for Obesity, Antihistamines, Drugs for Urologic Disorders, Drugs for Hematopoietic Disorders, Drugs for Dermatological Disorders, and Drugs for Bone DisordersOver 380 study questions!Nearly 600 annotated, full-color illustrations visually explain complex processes!Outline format ideal for concise review and foundational learning
This work presents a comprehensive contemporary framework for approaching target validation in drug discovery. It begins with a detailed description of new enabling technologies, including aptamers, RNA interference, functional genomics, and proteomics.
This volume encompasses all major methodologies to interrogate endocannabinoid systems (ECS) and endocannabinoids (eCBs) signaling. With increasing interest towards the manifold activities of eCBs, this book discusses the chemical, biochemical, and molecular biological assays, and activity of distinct elements of the ECS. These include membrane, nuclear receptors, biosynthetic and hydrolytic enzymes, and membrane transporters and oxidative enzymes. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.T
Chromium exists in nature as complexes of two stable oxidation states – trivalent chromium(III) and hexavalent chromium(VI). Although trivalent chromium is required in trace amounts for sugar and lipid metabolism in humans and its deficiency may cause a disease called chromium deficiency; hexavalent chromium is toxic and carcinogenic. As chromium compounds were used in dyes and paints and the tanning of leather, these compounds are often found in soil and groundwater at abandoned industrial sites, now needing environmental cleanup and remediation.
The Bioinorganic Chemistry of Chromium: From Biochemistry to Environmental Toxicology takes a critical look at what the biochemical data indicate about chromium’s role in the body and the biological mechanisms of its toxicology. Topics covered include:
What do we know about the biochemical roles and mechanisms of chromium?
Is chromium an essential element in the mammalian diet?
Is chromium(III) effective as a nutraceutical, a therapeutic agent, and as a supplement in animal feed?
What is the biochemistry behind the toxicology of chromium(III) and chromium(VI):the mechanisms of metabolism, genetic and epigenetic effects, and disruption of cell signalling?
What are the current chromium(VI) policies and positions from regulatory agencies?
The Bioinorganic Chemistry of Chromium: From Biochemistry to Environmental Toxicology is an important contribution to the bioinorganic and trace element biochemical fields which will find a place on the bookshelves of bioinorganic chemists, biochemists, inorganic chemists, toxicologists, nutritionists and regulatory affairs professionals.
Generic drugs are now familiar objects in clinics, drugstores, and households around the world. We like to think of these tablets, capsules, patches, and ointments as interchangeable with their brand-name counterparts: why pay more for the same? And yet they are not quite the same. They differ in price, in place of origin, in color, shape, and size, in the dyes, binders, fillers, and coatings used, and in a host of other ways. Claims of generic equivalence, as physician-historian Jeremy Greene reveals in this gripping narrative, are never based on being identical to the original drug in all respects, but in being the same in all ways that matter.H
Medical Pharmacology at a Glance is recognised as an excellent starting point for pharmacology study. This international best-seller is the perfect companion for all medical and health students, providing an accessible, visual overview of pharmacology. This 8th edition has been extensively updated, especially in the areas of anaesthetics, drugs used in AIDs, cardiovascular drugs, drugs used in anxiety, depression and schizophrenia, urological drugs, drug metabolism, as well as practical concerns such as drug indications and side effects.
‘I am unaware of any textbook which provides such comprehensive coverage of the field and doubt that this work will be surpassed in the foreseeable future, if ever!’From the foreword by Robert C. Moellering, Jr., M.D, Shields Warren-Mallinckrodt Professor of Medical Research, Harvard Medical School, USAWritten by a top international editorial teamExtensively updated to include new, existing and emerging drugsDivided into 4 sections, 258 chapters and presented in 2-volumesPresented and packaged in 2-volumes plus an e-bookKucers’ The Use of Antibiotics is the leading major reference work in this vast andrapidly developing field.
A time-saving, stress-reducing approach to learning the essential concepts of pharmacology
Great for USMLE review!
“This could be a very useful tool for students who struggle with understanding the most basic concepts in pharmacology for course and licensure examinations. 3 Stars.”–Doody’s Review Service
Basic Concepts in Pharmacology provides you with a complete framework for studying -– and understanding — the fundamental principles of drug actions. With this unique learning system, you’ll be able to identify must-know material, recognize your strengths and weaknesses, minimize memorization, streamline your study, and build your confidence.
Focuses on Biology, Pharmacology, and Therapeutic ApplicationsThe study and diverse applications of bioactive peptides traverse many sub-disciplines within chemistry, biology, physics, and medicine. Answering a long-standing need, Bioactive Peptides focuses on the biology, pharmacology, and therapeutic applications of endogenous peptide mediators and their analogues. Moving peptide science beyond chemical synthesis strategies and into the realms of peptide biology and therapeutics, it presents the overall contribution that peptide science has made to molecular, cellular, and whole organism biology, while also discussing future targets and therapeutic applications.B
This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. With current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently.
Genetic toxicology is recognized by geneticists and researchers concerned with the genetic impact of man-made chemicals. In Genotoxicity Assessment: Methods and Protocols, expert researchers in the field provide comprehensive genetic toxicology protocols. These include in vitro and in vivo protocols on mutation assays, cytogenetic techniques, and primary DNA damage, assays in alternate to animal models, and updated ICH guidelines. Written in the highly successful Methods in Molecular Biology series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, as well as key tips on troubleshooting and avoiding known pitfalls.
Authoritative and cutting-edge, Genotoxicity Assessment: Methods and Protocols seeks to aid research students and scientists working in regulatory toxicology as well as biomedical, biochemical and pharmaceutical sciences.
A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges.
Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects.
Pharmaceutical Microbiology may be defined as that part of microbiology that has a special bearing on pharmacy in all its aspects. This ranges from the manufacture and quality control of pharmaceutical products in general to an understanding of the mode of action of antibiotics.
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology.
The book provides a solid background on stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs. It is a one-stop reference for pharmaceutical scientists and chemists working with chiral drug molecules.
Showing 1–24 of 27 results