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الصفحة 3
الصفحة 3
Cancer drug safety and public health policy : A changing landscape
Description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. Opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.
Cancer drug resistance : methods and protocols
Discusses the latest techniques used to identify cancer drug resistance determinants at the molecular, cellular, and functional levels. Chapters in this book cover up-to-date topics including tumor-microenvironment cell co-culture methods and microfluidics systems; workflows for functional assessment of drug resistance in vitro and in vivo; quantitative techniques for identifying quiescent blood-flow circulating cells; and single-cell characterization methods, such as mass cytometry.
Cancer drug resistance
In Cancer Drug Resistance, leading scientists from the best academic institutions and industrial laboratories summarize and synthesize the latest discoveries concerning the changes that occur in tumor cells as they develop resistance to a wide variety of anticancer therapeutics, as well as suggest new approaches to the biology of drug resistance that may afford new therapeutic opportunities.
Cancer Chemoprevention ; Vol.2 : Strategies for Cancer Chemoprevention
In Cancer Chemoprevention, Volume 2: Strategies for Cancer Chemoprevention, leading chemopreventives investigators comprehensively describe the exciting methodologies that are accelerating progress in the chemoprevention field and review the state of clinical development of preventive agents in the major human cancer target organs. The authors provide sound guidelines for cancer chemopreventive drug development, detailing general strategies and methods for drug discovery, preclinical efficacy, characterization of precancers, safety evaluation of clinical cohorts, and clinical trial design.
CADD and informatics in drug discovery
Updates knowledge on recent advances in computational and bioinformatics tools/techniques and their practical applications in modern drug design and discovery programme. Also it encompasses fundamental principles, advanced methodologies and applications of various CADD approaches including several cutting-edge areas / presenting recent developments covering ongoing trends in the field of computer-aided drug discovery. Having contributions by a global team of experts, the book is expected to be an ideal resource for drug discovery scientists, medicinal chemists, pharmacologists, toxicologists, phytochemists, biochemists, biologists, RandD personnel, researchers, students, teachers and those working in the field of drug discovery. It will fill the knowledge gaps that exist in the current CADD approaches and methodologies/ protocols being widely used in both academic and research practices. Further, a special focus on current status of various computational drug design approaches (SBDD, LBDD, De-novo drug design, Pharmacophore-based search), bioinformatics tools and databases, computational screening and modeling of phytochemicals/natural products, artificial intelligence and machine learning, and network pharmacology and system biology would certainly guide researchers, students or readers to conduct their research in the emerging area(s) of interest. It is also expected to be highly beneficial to different stakeholders working in the pharmaceutical and biotechnology industries (RandD), the academic as well as research sectors. .
Brown and Mulholland’s drug calculations
A realistic practice problems and unique "proof" step in the answer key that allows you to double-check your answers to avoid medication errors. This edition continues to promote critical thinking, clinical judgment, and patient safety with respect to accurate drug dosages. Helpful worksheets, assessment tests, and Clinical Alerts call attention to situations in actual practice that have resulted in drug errors — giving you extensive hands-on practice for the Next Generation NCLEX® and beyond.
Breast cancer genetics, immunology, and immunotherapy : An interdisciplinary approach
Publishes comprehensive volumes on immune and genetic mechanisms of breast cancer diagnosis and prognosis. The role of molecular genetics, interleukins, chemokine receptor, and tumor-infiltrated lymphocytes-TILS in breast cancer are explained. Targeting myeloid determinants, SiRNA loaded in drug delivery nanosystems, nucleic acid and drug dual agent nanoplatforms, and oncolytic virotherapy are also discussed in the treatment of breast cancer, particularly in multidrug resistant and metastatic breast cancer.
Breast cancer chemosensitivity
In Breast Cancer Chemosensitivity, a group of world leading experts review critical aspects of resistance to systemic therapy in breast cancer patients. Beginning with a clinical overview of the problem Breast Cancer Chemosensitivity moves on to focus on the latest findings of molecular mechanisms of drug resistance. These include in-depth discussions on multidrug resistance by P-glycoprotein and the multidrug resistance protein family, resistance to therapeutic agent-induced apoptosis, cell cycle deregulation, deregulation of DNA repair, loss of tumor suppressor genes, integrin-mediated adhesion, insulin-like growth factors, epidermal growth factor, and ErbB2 in modulating breast cancer response to systemic therapy, especially, certain chemotherapeutic agents. Breast Cancer Chemosensitivity provides an example of using novel approaches for chemosensitization of breast cancer cells that gives readers an idea about the future direction in breast cancer treatment.
Brain and Heart Dynamics
Despite the increasing awareness that neural mechanisms are the primary cause of cardiac disease and its progression, therapy continues to focus on end-organ protection and does not approach the neural core of the problem. Growing public health problems such as heart failure are still treated with autonomic drugs that are 30-40 years old and simply act on cardiac receptors. However, it has now been shown that the progression of ischemic heart disease to heart failure is mainly due to abnormal central responses to incipient cardiac disease, with neural activation the primary cause rather than the consequence of cardiac remodeling.
Botanical drug products : Recent developments and market trends
Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process.
Biosimilars : Regulatory, clinical, and biopharmaceutical development
Provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.
Biophysical characterization of functional peptides
Presents reproducible and step-by-step procedures for the peptide synthesis, their characterization and applications. The volume includes an introductory section on in silico modelling of new peptide molecules, Molecular Dynamics Simulations, Docking, Electrostatic fingerprinting of peptides, and other modelling tools for peptide designing and optimization. Further, it covers protocols for the solid phase peptide synthesis, chromatographic and mass spectrometric characterization of peptides. Importantly, it covers methods for biophysical characterizations of peptides for their potential applications as drug delivery vehicles, peptide nano-assembly, bionanocatalysis, protein aggregation diseases, and peptide-based anti-bacterial.
Biopharmaceutics applications in drug development
This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.
Biopharmaceutics : From fundamentals to industrial practice
Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow.
Biopharmaceutical processing : Development, design, and Implementation of manufacturing processes
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies.
Biopharmaceutical drug design and development
Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery. Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.
Biomolecular and bioanalytical techniques : Theory, methodology and applications
Offers an introduction to, and a basic understanding of, a wide range of biophysical techniques. The text takes an interdisciplinary approach with contributions from a panel of distinguished experts. With a focus on research, the text comprehensively covers a broad selection of topics drawn from contemporary research in the fields of chemistry and biology. Each of the internationally reputed authors has contributed a single chapter on a specific technique. The chapters cover the specific technique’s background, theory, principles, technique, methodology, protocol and applications.
Biomedical applications and toxicity of nanomaterials
Covers the recent trends on the biological applications of nanomaterials, methods for their preparation, and techniques for their characterization. Further, the book examines the fundamentals of nanotoxicity, methods to assess the toxicity of engineered nanomaterials, approaches to reduce toxicity during synthesis. It also provides an overview of the state of the art in the application of Artificial intelligence-based methodologies for evaluation of toxicity of drugs and nanoparticles. The book further discusses nanocarrier design, routes of various nanoparticle administration, nano based drug delivery systems, and the toxicity challenges associated with each drug delivery method. It presents the latest advances in the interaction of nanoparticles with the cellular environment and assess nanotoxicity of these engineered nanoparticles. The book also explores the comparative and mechanistic genotoxicity assessment of the nanomaterials. This book is useful source of information for industrial practitioners, policy makers, and other professionals in the fields of toxicology, medicine, pharmacology, food, and drugs.
Biomaterials and bionanotechnology ; 1st ed.
Examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields.
Biomarkers for alzheimer’s disease drug development
Helping to accelerate Alzheimer’s disease drug development. Addressing the latest advances in preclinical and clinical research, including new insights into the molecular mechanisms and emerging therapeutic strategies, the book continues by exploring digital biomarkers and advanced neuroimaging analysis which will transform how clinical trials in the Alzheimer’s disease field are performed.
