Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds under development. In the most comprehensive resource on the topic, this third edition of Water-Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe the detailed discussion on solubility theories, solubility prediction models, the aspects of preformulation, biopharmaceutics, pharmacokinetics, regulatory, and discovery support of water-insoluble drugs to various techniques used in developing delivery systems for water-insoluble drugs. This book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies and featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. The aim of this book is to provide a handy reference for pharmaceutical scientists in the handling of formulation issues related to water-insoluble drugs. In addition, this book may be useful to pharmacy and chemistry undergraduate students and pharmaceutical and biopharmaceutical graduate students to enhance their knowledge in the techniques of drug solubilization and dissolution enhancement.

Natural Substances for Cancer Prevention explores in detail how numerous investigations in chemical biology and molecular biology have established strong scientific evidence demonstrating how the properties of naturally occurring bioactive chemicals hamper all stages of cancers (from initiation to metastasis). Accordingly, important goals for cancer prevention are the modification of our dietary habits and an increase in the intake of more anticancer-related natural substances. More significantly, the bioactive chemicals presented in the functional foods should be readily available, inexpensive, non-toxic, and nutritional.

The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases. Bio-Targets and Drug Delivery Approaches is an easy-to-read book for students, researchers and pharmaceutical scientists providing a comprehensive introduction to the principles of advanced drug delivery and targeting their current applications and potential future developments.

Building on the success of the previous editions, the Textbook of Drug Design and Discovery, Fifth Edition, has been thoroughly revised and updated to provide a complete source of information on all facets of drug design and discovery for students of chemistry, pharmacy, pharmacology, biochemistry, and medicine. The information is presented in an up-to-date review form with an underlying and fundamental focus on the educational aspects. Beginning with an introduction to drug design and discovery, the first eight chapters cover molecular recognition, ligand-based drug design, and biostructure-based drug design. The authors also discuss drug-like properties and decision making in medicinal chemistry, chemical biology, natural products in drug discovery, and in vivo imaging in drug discovery. The middle six chapters provide an overview of peptide and protein drug design, prodrugs in drug design and development, and enzyme inhibitors. The authors also go through receptors (structure, function, and pharmacology), ion channels (structure and function), and neurotransmitter transporters (structure, function, and drug binding). The following chapters address important neurotransmitter systems, GABA and glutamic acid receptors and transporter ligands, acetylcholine, histamine, dopamine and serotonin, and opioid and cannabinoid receptors. The book concludes with an examination of neglected diseases, anticancer agents, tyrosine kinase receptors, and antibiotics.

Recent advances in high-throughput gene sequencing and other omics biotechnologies have served as a springboard for the field of pharmacogenomics. Pharmacogenomics is now generally accepted as the major determinant of variable drug safety, efficacy, and cost-effectiveness. Therefore, widespread use of pharmacogenomics for patient care has become a critical requirement. There is an unprecedented urgency for aspiring and practicing clinicians to become trained on how to interpret data from pharmacogenomic testing in preparation for the future of healthcare-i.e., personalized medicine. Applying Pharmacogenomics in Therapeutics provides timely coverage of the principles, practice, and potential of pharmacogenomics and personalized medicine. Comprised of chapters contributed by well-established pharmacologists and scientists from US and Chinese academia and industry, this authoritative text: Demonstrates how to apply the principles of pharmacogenomics and its biotechnologies in patient care Depicts the use of genetic biomarkers in drug discovery and development, laboratory medicine, and clinical services Describes the practice of pharmacogenomics in the treatment of cancers, cardiovascular diseases, neurologic and psychiatric disorders, and pulmonary diseases Discusses the merging of pharmacogenomics and alternative medicine, as well as the integration of pharmacogenomics into pharmacoeconomics Each chapter begins with the key concepts, followed by in-depth explorations of case reports or critical evaluations of genetic variants/biomarkers, and concludes with questions for self-examination.

Organic chemistry research has moved rapidly toward synthesis and medicinal application of nitrogen-containing compounds such as triazenes, triazines, and hydroxytriazenes due to their excellent biological activities. Many of them are presently in clinical trials. Triazene compounds have excellent medicinal properties and limited toxicity. Hydroxytriazenes are excellent chelating agents for transition metals. Newer studies show very promising biological and medicinal applications of these classes of compounds. Hydroxytriazenes and Triazenes: The Versatile Framework, Synthesis, and Medicinal Applications highlights synthetic methods, recent advances, and potential applications of triazines, triazenes, and hydroxytriazenes. This book includes holistic information on synthetic methods for novel compounds based on this moiety, up-to-date information on the how and why of their diverse or even multitargeted medicinal application, and future state of the art of both aspects. Other features include: Highlights recent advances and diverse possible applications of biological functions Covers the chemistry of triazine, triazene, and hydroxytriazene systems On the basis of in silico predictions, the book highlights synthetic methods and their applications A valuable source of information for those actively engaged in medicinal chemistry, drug discovery, and synthetic organic chemistry

Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

*A focus on normal theory linking average power, expected power, predictive power, assurance, conditional Bayesian power and Bayesian power. *Extensions of the concepts to binomial, and time-to-event outcomes and non-inferiority trials *An investigation into the upper bound on average power, assurance and Bayesian power based on the prior probability of a positive treatment effect *Application of assurance to a series of trials in a development program and an introduction of the assurance of an individual trial conditional on the positive outcome of an earlier trial in the program, or to the successful outcome of an interim analysis *Prior distribution of power and sample size *Extension of the basic approach to proof-of-concept trials with dual success criteria *Investigation of the connection between conditional and predictive power at an interim analysis and power and assurance *Introduction of the idea of surety in sample sizing of clinical trials based on the width of the confidence intervals for the treatment effect, and an unconditional version.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Include advance knowledge and detailed developments in natural product science Discusses about the most important phytopharmaceuticals used in pharmaceutical industries Explores the analysis and classification of novel plant-based medicinal compounds Includes standardization, quality control, global trade of natural products Gives a deep understanding related to recent advances in the herbal medicines to treat various ailments Discusses about national and WHO regulations and policies related to herbal medicine Covers the complete profile of some important traditional medicinal plants especially their historical background, biology and chemistry

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development' crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.

Calculations in Chemical Kinetics for Undergraduates aims to restore passion for problem solving and applied quantitative skills in undergraduate chemistry students. Avoiding complicated chemistry jargon and providing hints and step wise explanations in every calculation problem, students are able to overcome their fear of handling mathematically applied problems in physical chemistry. This solid foundation in their early studies will enable them to connect fundamental theoretical chemistry to real experimental applications as graduates. Additional Features Include: Contains quantitative problems from popular physical chemistry references. Provides step by step explanations are given in every calculation problem. Offers hints to certain problems as "points to note" to enable student comprehension. Includes solutions for all questions and exercises. This book is a great resource for undergraduate chemistry students however, the contents are rich and useful to even the graduate chemist that has passion for applied problems in physical chemistry of reaction Kinetics.

Calculations in Chemical Kinetics for Undergraduates aims to restore passion for problem solving and applied quantitative skills in undergraduate chemistry students. Avoiding complicated chemistry jargon and providing hints and step wise explanations in every calculation problem, students are able to overcome their fear of handling mathematically applied problems in physical chemistry. This solid foundation in their early studies will enable them to connect fundamental theoretical chemistry to real experimental applications as graduates. Additional Features Include: Contains quantitative problems from popular physical chemistry references. Provides step by step explanations are given in every calculation problem. Offers hints to certain problems as "points to note" to enable student comprehension. Includes solutions for all questions and exercises. This book is a great resource for undergraduate chemistry students however, the contents are rich and useful to even the graduate chemist that has passion for applied problems in physical chemistry of reaction Kinetics.

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Covering all major arthropods of medical importance worldwide, this award-winning resource has established itself as a standard reference for almost 25 years. With the globilization of commerce and the world becoming more intimately connected through the everyday ease of travel, unknown arthropod species are being increasingly encountered. This means access to up-to-date, authoritative information in medical entomology has never been more important. Now in its seventh edition, this book maintains its well-acclaimed status as the ultimate easy-to-use guide to identify disease-carrying arthropods, the common signs and symptoms of vector-borne diseases, and the current recommended procedures for treatment. Includes an in-depth chapter with diagnostic aids to help physicians to recognize and accurately diagnose arthropod-related diseases and conditions more easily Updates all chapters with the latest medical and scientific findings, including Zika virus, red meat allergy, new viruses found in ticks, and vaccine development for malaria and dengue fever Presents a greater medical parasitology emphasis throughout Offers electronic downloads containing additional photographs of arthropod-caused diseases and lesions, as well as instructional videos with pest identification aids, basic entomology, and insect and pest ecology. Illustrated throughout with detailed color images to aid identification, The Goddard Guide to Arthropods of Medical Importance, Seventh Edition will remain an essential guide for physicians, public health officials, and pest control professionals.

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery - including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and parenteral administration. Pulmonary drug development is therefore a highly specialized area because of its many unique issues and challenges. Rapid progress is being made and offers novel solutions to existing treatment problems. Advances in Pulmonary Drug Delivery highlights the latest developments in this field.

This comprehensive book brings together experts from both the marine science and pharmacy disciplines to relay important aspects on the pharmaceutical and nutraceutical values of 175 species of bony and cartilaginous fishes as well as the uses of fish processing byproducts and wastes.Presented in an easy-to-read style, the volume provides precise identification of freshwater and marine fishes possessing pharmaceutical and nutraceutical compounds along with over 180 photographs. Aspects covered include biology, ecology, diagnostic features, and pharmaceutical and nutraceutical compounds along with their activities for each of the fish included. The book details the bioactive compounds, including fish muscle proteins, peptides, collagen and gelatin, fish oil, etc., from such species, as well as the bioactive peptides that are derived from various fish muscle proteins, which have various biological activities, including cardio protective, antihypertensive, anticancer, anti-diabetic, antibacterial, anticoagulant, anti-inflammatory, and antioxidant activities. Also discussed are the nutritional benefits of fish consumption, which are largely due to the presence of proteins, unsaturated essential fatty acids, minerals, and vitamins. The waste products obtained during fish processing are also a potential source of bioactive peptides that can be used as a source of nitrogen and amino acids, which have immunomodulatory, antibacterial, antitrombotic, and antihypertensive properties. This volume provides the information needed to tap into these vast pharmaceutical and nutraceutical benefits. Pharmaceuticals and Nutraceuticals from Fish and Fish Wastes will be of great use for students and researchers of disciplines such as pharmaceutical sciences, marine/fisheries sciences, marine microbiology, and marine biotechnology. It will also be a standard reference for libraries of colleges and universities and a guide for pharmaceutical companies involved in the development of new drugs from fishes and their wastes.

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

A collection of information on the use of color additives in the food, cosmetic and medical industries. This Third Edition documents important recent developments such as newly listed products, delisted products, modernized specifications and improved analytical technology, new manufacturers and suppliers. A general background of color additives is given including their history, regulation, areas of use and purity requirements.

Reviews critical issues (e.g., endpoint/margin selection, sample size requirement and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval. Makes recommendations to accurately and reliably evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master protocols such as platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development such as gene therapy.

Emphasizes recent advances in biotechnologies that will help in tackling emerging global health challenges Provides detailed information on how to harness indigenous bio-resources including microorganisms and plants for health care delivery Introduces new frontiers in the area of molecular diagnostics and DNA forensic science and bioinformatics with case studies, recent advances in medical insect biotechnology, molecular genetics of pest towards the exploitation of arthropod midgut components to develop interventions against infectious diseases Reviews bioactive molecules derived from commonly used and underutilized medicinal plants that could be used to develop novel drugs for improved healthcare delivery Discuss current approaches in medical and biopharmaceutical biotechnology, deployment of inexpensive genomics-based vector surveillance for effective disease outbreak prediction and control of mosquito-borne viruses

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.