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.

"Novel Psychoactive Substances: Classification, Pharmacology and Toxicology" provides readers with background on the classification, detection, supply and availability of novel psychoactive substances, otherwise known as "legal highs." This book also covers individual classes of novel psychoactive substances that have recently emerged onto the recreational drug scene and provides an overview of the pharmacology of the substance followed by a discussion of the acute and chronic harm or toxicity associated with the substance. Written by international experts in the field, this multi-authored book is a valuable reference for scientists, clinicians, academics, and regulatory and law enforcement professionals.
Includes chapters written by international experts in the field.Provides a comprehensive look at the classification, detection, availability and supply of novel psychoactive substances, in addition to the pharmacology and toxicology associated with the substance. Offers a single source for all interested parties working in this area, including scientists, academics, clinicians, law enforcement and regulatory agencies. Provides a full treatment of novel psychoactive substances that have recently emerged onto the recreational drug scene including mephedrone and the synthetic cannabinoid receptors in spice / K2 ."

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields.

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.

Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization.

"Principles of Clinical Pharmacology" is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science.

The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics

* Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions. * Offers an expanded regulatory section that addresses US and international issues and guidelines. * Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response. * Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III.