This book provides comprehensive information of the nanotechnology-based pharmaceutical product development including a diverse range of arenas such as liposomes, nanoparticles, fullerenes, hydrogels, thermally responsive externally activated theranostics (TREAT), hydrogels, microspheres, micro- and nanoemulsions and carbon nanomaterials.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart.
The chemicals, pharmaceuticals and biotechnology industries worldwide rely upon being able to patent inventions in order to protect investment in research and development, and to reap commercial rewards.
This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments.
Years of extensive investigation into neurophysiology, neurochemistry, and behavioral pharmacology have produced an understanding of antipsychotic medication action that is much more refined than the original dopamine hypothesis.
Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics.
Since the publication of the bestselling first edition of CRC Desk Reference of Clinical Pharmacology, dramatic discoveries in molecular medicine along with rapid technological advances have revolutionized the diagnosis and resulted in new medications to be used in the treatment of a broad range of human diseases.
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
In biostatistical research and courses, practitioners and students often lack a thorough understanding of how to apply statistical methods to synthesize biomedical and clinical trial data.
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO).
Cannabinoids Cannabinoids is a broad term covering a group of natural products from Cannabis sativa, one of which locks on to specific receptors protein molecules on the surface of cells known as cannabinoid receptors.
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect.
Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry.
With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology.
With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery.
For more than five decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3).
This book explores the relationship between the gut microbiome and cancer, illuminating various facets from fundamental roles to personalized therapies.
The book Nanopharmaceuticals in regenerative medicine is a collective and comprehensive volume of the latest innovations in nanoscience technology for practical use in clinical, biomedicine and diagnostic arena.
This book discusses various fundamental aspects of polysaccharide based nano-biocarrier drug delivery systems and its application in the delivery of small molecules, proteins, peptides, oligonucleotides and genes.
Tinospora cordifolia stem is used as a tonic, vitalizer, and as a remedy for metabolic disorders to treat allergies, diabetes, dysentery, jaundice, heart diseases, leprosy, rheumatoid arthritis, skin diseases, and urinary disorders.
This important and exciting work brings together a high-calibre group of experts to discuss the practical application of genomic information to the development of drugs.
Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations.
Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs.
Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems.
This important new book provides the fundamental understanding of the peptide and protein drug delivery systems with a special focus on their nanotechnology applications.
The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products.
Providing detailed examples and valuable discussions of the development of specific methods, approaches, and legislation, this reference presents the latest information on the impact of toxicology on the regulatory process and illustrates the interrelationship between toxicology and the regulation of chemicals, pharmaceutical compounds, and food su
The human brain is made up of billions of neurons that communicate with each other through chemical messengers, which are referred to as neuroactive substances.
This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.
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.
Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives Brings together the most current advances in the mass spectrometry technology and related method in protein analysis
This book offers an important reference source about the most common classes of pesticides for researchers engaged in the area of neurotoxicology, metabolism, and epidemiology.
