This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer's disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

The purpose of this book is to highlight some of latest developments and applications of CRISPR, RNA, and DNA to treat diseases ranging from cancers to cardiovascular and degenerative disorders. It also features innovations of the delivery methods for nucleic acids ranging from nanodevices made from DNA and pseudo amino acids to viral vectors. This is an ideal book for academics, clinicians, and students interested in gene therapy.

Advanced Porous Biomaterials for Drug Delivery Applications probes cutting-edge progress in the application of advanced porous biomaterials in drug delivery fields. These biomaterials offer promise in improving upon the design, cost, and creation of potent novel drug delivery systems. The book focuses on two categories: nature engineered and synthetic advanced porous biomaterials, with a wide range of low-cost porous biomaterial-based systems that have been used for the delivery of diverse drugs through in vitro/in vivo approaches. Details how advanced porous biomaterial-assisted systems improve essential properties in drug delivery applications Explains how advanced porous biomaterials systems are being used and explored to improve overall performances of drug delivery systems in mitigating a variety of diseases Emphasizes major applications in drug delivery such as controlled release, cancer therapy, and targeted delivery, and with focus on oral, topical, and transdermal applications Focuses on both naturally available and synthetic low-cost advanced porous biomaterials and their role in enhancing important parameters in drug delivery applications Accessible to readers with bio and non-bio backgrounds This book is an ideal reference for academics, researchers, and industry professionals in the interdisciplinary fields of biomedicine and biomedical engineering, pharmaceuticals, materials science, and chemistry.

The applications of nanoparticulate drug delivery have gained significant attention in cancer diagnosis and treatment. Owing to their unique features and design, nanomedicines have made remarkable progress in eliminating dreadful tumors. Research in cancer nanomedicine spans multitudes of drug-delivery systems that include high tumor-targeting ability, sensitivity toward tumor microenvironments, and improved efficacy. Various nanocarriers have been developed and approved for anti-tumor drug targeting. These nanocarriers, such as liposomes, micelles, nanotubes, dendrimers, and peptides, offer several advantages including high selectivity, multifunctionality, specificity, biocompatibility, and precise control of drug release. This book provides complete information about each aspect of nanomaterials and nanotherapeutics, including synthesis, analysis, disease diagnosis, mechanistic insight, targeted drug delivery, and clinical implications in a concise and informative way. It presents simple and reader-friendly representations of the mechanisms of action of nanomaterials on cellular targets and highlights the challenges in targeted drug delivery with ongoing chemotherapeutic drugs.

Organ Specific Drug Delivery and Targeting to the Lungs provides up to date information on the multidisciplinary field of particle engineering and drug delivery to the lungs, including advancements of nanotechnology. The text presents a unique, pragmatic focus with case studies, that help translate scientific understanding to practical implementation. In addition to highlighting the successful case studies, it also offers practical advice on watchouts, limitations, and 'bookend' boundaries involved in the stages of testing and development. Additional Features Include: Provides an account of particle engineering, discovery, biology, development, and delivery in relation with the advancements of nanotechnology, unlike any previous book. Brings together the leading experts and researchers in the field to critically assess and discuss various topics influencing drug delivery. Highlights the interplay of different scientific disciplines and the balance of requirements that are critical to molecule and product design. With the strategic focus on what matters during new product development, this book provides a guide to understanding and navigating new drug discovery and development for lung targets.

This book casts new light on the field of oral drug absorption. It outlines both the concept of the past and the novel concept of Finite Absorption Time (FAT). In addition, the authors explore the correlated need for re-definition of bioavailability, bioequivalence providing a plethora of experimental data. Accordingly, this book is intended for academics/students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations. It can be used for teaching purposes in under- and post-graduate courses dealing with biopharmaceutics, pharmacokinetics and biomedical engineering.

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

This edited volume brings together the expertise of numerous specialists on the topic of particles - their physical, chemical, pharmacological and toxicological characteristics - when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.

This collection explores detailed experimental protocols necessary for setting up a variety of in vitro cytochrome P450 (CYP) assays that are vital in selecting drug candidates in a drug discovery pipeline. Major factors affecting drug metabolism include CYP expression levels, kinetic parameters for individual CYP enzymes, CYP inhibition and induction, time-dependent inhibition (TDI), CYP stability, non-CYP stability, UDP-glucuronosyltransferases (UGT) stability, excretion mechanisms, and drug-drug interactions (DDI), all addressed in this volume. Written for the Methods in Pharmacology and Toxicology series, chapters include helpful background information on the in vitro assay, a list of all the materials, reagents, and equipment necessary to carry out the assay, a step-by-step protocol, notes containing common and unexpected experimental problems in the assay, as well as references containing important supplementary reading. Authoritative and practical, Cytochrome P450: In Vitro Methods and Protocols serves as a key guide for researchers in the area of discovery and development of new medicines.

Key Features- Highlights recent advances in phytomedicine formulation development based on nanotechnology approaches, while also discussing the pharmacological property of Green synthesized ZnO particles focusing on the clinical perspective. Explores development of nanoparticles, synthesis techniques, characterization techniques, tissue engineering applications, biological applications, and multi-functional applications for cancer, inflammatory diseases, Alzheimer's disease and diabetes. Serves as a valuable guide for early career researchers, young scientists, academics and scientists working in various field like pharmaceutical, life sciences, Nano biotechnology about the applications of nanoparticles derived from plant sources.

Core-Shell Nanostructures for Drug Delivery and Theranostics: Challenges, Strategies and Prospects for Novel Carrier Systems contains valuable chapters that deal with the fundamentals of nanotechnology for drug delivery, recent developments and research in core-shell nanoparticles for drug-delivery and theranostic applications, and the potential and applications of core-shell nanofiber. This book is a highly valuable resource for scientists interested in the design and development of innovative drug delivery systems, researchers and graduate/postdoctoral students engaged in biomaterials for drug delivery, and R&D managers in the biomaterials and pharmaceutical industry.

Leading researchers are specially invited to provide a complete understanding of a key topic within the multidisciplinary fields of physiology, biochemistry and pharmacology. In a form immediately useful to scientists, this periodical aims to filter, highlight and review the latest developments in these rapidly advancing fields.

Chemical Sciences in Early Drug Discovery: Medicinal Chemistry 2.0 describes how new technologies and approaches can be used to improve the probability of success in fulfilling the perennial goal of finding and developing new drugs. Drawing on the author's extensive experience consulting and teaching in medicinal chemistry, the book outlines ways in which medicinal chemistry is widening its reach to meet modern demands, and how modern technologies and approaches are facilitating this growth into new fields. Supported by examples throughout, the book is a practical resource for organic-medicinal chemists, biological chemists and pharmacologists involved in drug discovery.

Summarizes insulin and the closely related IGF-1 receptor signaling. Depicts concepts of insulin resistance. Highlights the importance of conserved brain insulin signaling for brain function, metabolism and behavior Describes potential behavioral and pharmacological approaches to support brain insulin signaling

The book provides valuable information on wild plants and their ethnopharmacological properties, discussion on ethnobotany, phytotherapy, diversity, chemical and pharmacological properties including antifungal, anti-inflammatory and antiprotozal properties. The chapters include a wide range of case studies, giving updated evidence on importance of wild plant resources from different countries including Nepal, India, Brazil, Chile, Argentina, Colombia, Egypt, Peru, etc. In addition, some specific species are used to explain their potential properties. Discussing traditional usage and pharmacological properties of wild plants, this book is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policy making, etc.

Epothilones have received unusual attention over the past ten years. They are novel antitumor drugs which very much like their predecessor paclitaxel (Taxol) act via microtubule stabilization. In comparison to paclitaxel and a number of alternative drugs with a similar mode of bioaction (e.g. laulimalide, eleutherobin, peluroside, discodermolide) the epothilones have significant advantages, above all very high activity in the nanomolar range and low susceptibility towards multidrug resistance. Epothilone B and several derivatives thereof are in phase I-III clinical trials; one of them (ixabepilone, BMS) is already on the market, others are supposed to appear on the market in the near future. All naturally occurring epothilones have been isolated from Sorangium cellulosum; their antitumor action is traced back to the stabilization of microtubules. In consequence, the formation of the mitototic spindle is prohibited and the cell undergoes apoptosis.

This work presents a systematic review of traditional herbal medicine and their active compounds, as well as their mechanism of action in the prevention and treatment of diabetes and obesity. The side effects and safety of herbal-derived anti-diabetic and anti-obesity phytochemicals are detailed in depth, and the text has a strong focus on current and future trends in anti-diabetic medicinal plants. This unique and comprehensive text is the only current book on the market focusing exclusively on medicinal plants used to combat obesity and diabetes. An introductory chapter focuses on diabetes and obesity and introduces the major causes and main treatments of this increasing epidemic in modern society. Readers are then introduced to medicinal plants, including details on their therapeutic aspects, plus side effects and safety. Following chapters focus on anti-diabetic and anti-obesity medicinal plants, as well as phytogenic natural products in the treatment of each. The text closes by focusing on present and future trends and challenges in these medicinal plants. Anti-diabetes and Anti-obesity Medicinal Plants and Phytochemicals: Safety, Efficacy, and Action Mechanisms is a much-needed and truly original work, finally presenting in one place all the necessary information on medicinal plants used in conjunction with obesity and diabetes prevention.

This book highlights recent innovative work in nutraceutical delivery systems, focusing on strategies and approaches for delivering maximum health benefits from foods. It presents recent research-oriented work from diverse global perspectives on isolation techniques for nutraceutical components, phytosomes, liposomes, solid dispersions, micelles, self-emulsifying drug delivery systems, microemulsions, solid lipid nanoparticles, polyelectrolyte complexes, oral delivery, polymeric nanoparticles, and more. The book begins with an overview of recent facts and diverse perspectives on the use of nutraceuticals in medicine and proceeds to discuss recent techniques in isolation of nutraceuticals from plants and in solubility enhancement. It looks at innovations and advances in nanoparticles-based nutraceutical delivery, such as in solid lipid nanoparticles (SLNs), fabrication methods of therapeutic nanoparticles, and polymeric nanoparticles-based nutraceutical delivery system. It also discusses vesicular delivery systems and biphasic systems for nutraceutical applications. The book also looks at the challenges in oral delivery and the latest taste-masking techniques.

Compatibility of Pharmaceutical Products and Contact Materials

Dennis Jenke

Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers

"Compatibility of Pharmaceutical Products and Contact Materials" helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results.

Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, "Compatibility of Pharmaceutical Products and Contact Materials" directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe:

Pertinent regulations and practical ways to meet guidelines

Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development

Materials characterization and the materials screening process

Component and/or system qualification (illustrated by several case studies)

Performing validation/migration studies and interpreting and reporting the results

Creating a product registration dossier and putting it through regulatory review

Product maintenance (Change Control) from an extractables and leachables perspective

Likely future developments in extractables and leachables assessment

Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature.

Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, "Compatibility of Pharmaceutical Products and Contact Materials" supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.

This book offers a broad summary of the wild plants and their usage, as well as the growing interest in ethnopharmacology research. The book comprises of important issues such as diversity of wild plants with emphasis on medicinal and food plants, threats to wild plants and traditional ethnobotanical knowledge, their uses in skin diseases, snake-bites, in cosmeceuticals, etc. Moreover, the ethnopharmacological relevance of wild plants in Latin America has been discussed. The chapters include a wide range of case studies, giving updated evidence on the importance of their wild plant resources from different countries including Peru, Nepal, Bangladesh, India, Pakistan, Brazil. In addition, some specific species are used to explain their potential properties, as well as the dangers of their use without guidance of trained natural healers. The book discusses traditional usage and properties of wild plants and is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policymakers, etc.

Provides insight to extremophiles. Unveils the mysticism of extreme environments. Explores applications of extremophiles in biorefineries. Throws light on the advancement of industrially important extremozymes. Explores applications in biofilms and microbial corrosion.

1. Emphasis on the role of education to combat behavioral changes in AMR 2. Useful for people doing research in Microbiology, Public Health Sciences, Pharmaceutical Biology and Biotechnology 3. Discusses comparative economic analysis of AMR burden in Europe and other world regions 4. Reviews measures to preserve the pre-existing antimicrobials

"Controlled Release in Oral Drug Delivery" provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.

With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

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.