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Elsevier

Libros en Ciencias Farmacéuticas

  • Formulation and Device Lifecycle Management of Biotherapeutics

    A Guidance for Researchers and Drug Developers
    • 1 Edición
    • Beate Bittner + 1 más
    • Inglés
    Today, the pressure on healthcare costs and resources is increasing, and especially for biopharmaceuticals that require parenteral administration, the inherent complex and invasive dosing procedure adds to the demand for efficient medical management. In light of the COVID-19 pandemic the value of drug delivery technologies in enabling a flexible care setting is broadly recognized. In such a setting, patients and their caregivers can choose the place of drug administration based on individual preferences and capabilities. This includes not only dosing in the clinic but also supervised at-home dosing and self-administration for eligible patients. Formulation and Device Lifecycle Management of Biotherapeutics: A Guidance for Researchers and Drug Developers covers the various aspects of improving drug delivery of biological medicines with the ultimate goal to reduce dosing complexity associated with parenteral administration and, thus, enhance patient experience and drug administration-relat... healthcare capacity. The target audience are multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development. This includes pharmacology and medical experts in charge of generating nonclinical and clinical data to support approval of novel dosing regimens, and drug delivery scientists and engineers responsible for technical particulars of product optimizations. Moreover, professionals in market access and commercial functions are expected to benefit from the discussions about the impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.

  • Stimuli-Responsive Nanocarriers

    Recent Advances in Tailor-Made Therapeutics
    • 1 Edición
    • Virendra Gajbhiye + 2 más
    • Inglés
    Stimuli-Responsive Nanocarriers: Recent Advances in Tailor-Made Therapeutics compiles dispersed knowledge into a complete and comprehensive source to help researchers understand and progress stimuli-responsive nanocarriers. The book contains recent advancements made in the field of stimuli-responsive nanocarriers with their application in controlled drug delivery against various diseases. It focuses on the design, mechanism, construction, therapeutic application and future challenges of stimuli-responsive nanocarriers which will help new researchers in designing next generation tailor-made advanced therapeutics. Finally, the book covers future aspects and challenges present in the route of development of stimuli responsive nanocarriers for disease therapeutics. Various recent advances and biomedical applications assembled in this book will guide scientists on how to design and develop novel controlled drug release systems.

  • The Detection of Biomarkers

    Past, Present, and the Future Prospects
    • 1 Edición
    • Sibel A. Ozkan + 2 más
    • Inglés
    Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical　researchers... Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection.

  • Targeted Cancer Imaging

    Design and Synthesis of Nanoplatforms based on Tumor Biology
    • 1 Edición
    • Mehdi Azizi + 3 más
    • Inglés
    Targeted Cancer Imaging: Design and Synthesis of Nanoplatforms based on Tumour Biology reviews and categorizes imaging and targeting approaches according to cancer type, highlighting new and safe approaches that involve membrane-coated nanoparticles, tumor cell-derived extracellular vesicles, circulating tumor cells, cell-free DNAs, and cancer stem cells, all with the goal of pointing the way to developing precise targeting and multifunctional nanotechnology-based imaging probes in the future. This book is highly multidisciplinary, bridging the knowledge gap between tumor biology, nanotechnology, and diagnostic imaging, and thus making it suitable for researchers ranging from oncology to bioengineering. Although considerable efforts have been conducted to diagnose, improve and treat cancer in the past few decades, existing therapeutic options are insufficient, as mortality and morbidity rates remain high. One of the best hopes for substantial improvement lies in early detection. Recent advances in nanotechnology are expected to increase our current understanding of tumor biology, allowing nanomaterials to be used for targeting and imaging both in vitro and in vivo experimental models.

  • Regulatory Affairs in the Pharmaceutical Industry

    • 1 Edición
    • Javed Ali + 1 más
    • Inglés
    Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

  • Nanoparticle Therapeutics

    Production Technologies, Types of Nanoparticles, and Regulatory Aspects
    • 1 Edición
    • Prashant Kesharwani + 1 más
    • Inglés
    Nanoparticle therapeutics: Production Technologies, Types of Nanoparticles, and Regulatory Aspects employs unique principles for applications in cell-based therapeutics, diagnostics and mechanistics for the study of organ physiology, disease etiology and drug screening of advanced nanoparticles and nanomaterials. The book focuses on the extrapolation of bioengineering tools in the domain of nanotechnology and nanoparticles therapeutics, fabrication, characterization and drug delivery aspects. It acquaints scientists and researchers on the experiential and experimental aspects of nanoparticles and nanotechnology to equip their rational application in various fields, especially in differential diagnoses and in the treatment of diverse diseased states. This complete resource provides a holistic understanding of the principle behind formation, characterization, applications, regulations and toxicity of nanoparticles employing myriad principles of nanotechnology. Investigators, pharmaceutical researchers, and advanced students working on technology advancement in the areas of designing targeted therapies, nanoscale imaging systems and diagnostic modalities in human diseases where nanoparticles can be used as a critical tool for technology advancement in drug delivery systems will find this book useful.

  • Side Effects of Drugs Annual

    A Worldwide Yearly Survey of New Data in Adverse Drug Reactions
    • 1 Edición
    • Volumen 43
    • Sidhartha D. Ray
    • Inglés
    Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 43, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a critical survey of new data and trends in adverse drug reactions and interactions. Topics covered in this new release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressants, Lithium, Drugs of Abuse, Hypnotics and Sedatives, Antipsychotic Drugs, Antiepileptics, Opioid Analgesics and Narcotic Antagonists, Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout, and much more.

  • Chitosan in Drug Delivery

    • 1 Edición
    • Md Saquib Hasnain + 2 más
    • Inglés
    Chitosan in Drug Delivery provides thorough insights into chitosan chemistry, collection, chemical modifications, characterization and applications in the pharmaceutical industry and healthcare fields. The book explores molecular weight, degree of deacetylation and molecular geometry, emphasizing recent advances in the field as written by academic, industry and regulatory scientists. It will be a useful resource for pharmaceutical scientists, including industrial pharmacists, analytical scientists, postgraduate students, health care professionals and regulatory scientists actively involved in pharmaceutical product and process development in natural polymers containing drug delivery.

  • Practical Aspects of Vaccine Development

    • 1 Edición
    • Parag Kolhe + 1 más
    • Inglés
    Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysacchari... conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.

  • Phytochemical Profiling of Commercially Important South African Plants

    • 1 Edición
    • Alvaro Viljoen + 4 más
    • Inglés
    Phytochemical Profiling of Commercially Important South African Plants comprises a carefully selected group of plant species that are of interest to researchers and industry partners who would like to investigate the commercialization of plant species. The book presents 25 botanicals selected based on commercial relevance. For each of the species, the following topics are covered: botanical description and distribution, phytochemistry (including chemical structures), HPTLC fingerprint analysis, UPLC analysis, and GC analysis (the latter only in the case of essential oil-bearing species). Using standard methodology, high-level chromatographic fingerprints have been developed for better understanding. Different methods are succinctly summarized allowing for the rapid identification of botanical raw materials and formulated consumer products. This book will be extremely valuable to researchers in the field who wish to rapidly identify the constituents and for those who want to prepare formulations of plant material for commercial applications. This work will also be a valuable resource in the field of pharmacognosy.

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