This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

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.

Beer is made up of various bioactive substances containing antioxidants and specific ingredients with potentially beneficial effects on the human body if consumed in moderation. In the production process, the addition of hops, cereals, and malt leads to an increased content of naturally occurring antioxidant compounds in beer, mainly phenolic compounds. This book presents information on the history, compositional analysis, and brewing process of craft beers. It covers aspects of fruit fortification to different craft brewed beers and how it will enhance the nutritional composition, antioxidant properties, color and sensory attributes of beers. The alcohol industry continues to grow quickly worldwide, this book provides relevant research literature about the recent studies and experimentation about beers which will be helpful to students, researchers, industrialists, producers, and many others. The incorporation of fruits for the fortification of beers is a topic of interest resulting in the need for more innovative and effective methods and steps in the production of newer variants of beers.

Beer is made up of various bioactive substances containing antioxidants and specific ingredients with potentially beneficial effects on the human body if consumed in moderation. In the production process, the addition of hops, cereals, and malt leads to an increased content of naturally occurring antioxidant compounds in beer, mainly phenolic compounds. This book presents information on the history, compositional analysis, and brewing process of craft beers. It covers aspects of fruit fortification to different craft brewed beers and how it will enhance the nutritional composition, antioxidant properties, color and sensory attributes of beers. The alcohol industry continues to grow quickly worldwide, this book provides relevant research literature about the recent studies and experimentation about beers which will be helpful to students, researchers, industrialists, producers, and many others. The incorporation of fruits for the fortification of beers is a topic of interest resulting in the need for more innovative and effective methods and steps in the production of newer variants of beers.

This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed.This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions. Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Discusses siRNA, mRNA, and plasmid manufacturing. Describes the importance of supplier-sponsor synergies on the path to commercialization. Diverse audience with a large number of individuals in the core technologies and supportive practices.

Design of Hybrid Molecules for Drug Development reviews the principles, advantages, and limitations involved with designing these groundbreaking compounds. Beginning with an introduction to hybrid molecule design and background as to their need, the book goes on to explore a range of important hybrids, with hybrids containing natural products, molecules containing NO- and H2S-donors, dual-acting compounds acting as receptor ligands and enzyme inhibitors, and the design of photoresponsive drugs all discussed. Drawing on practical case studies, the hybridization of molecules for development as treatments for a number of key diseases is then outlined, including the design of hybrids for Alzheimer's, cancer, and malaria. With its cutting-edge reviews of breaking developments in this exciting field, the book offers a novel approach for all those working in the design, development, and administration of drugs for a range of debilitating disorders.

General compendium of HDAC inhibitors with deep emphasis on toxicity issues of synthetic HDAC inhibitors Various groups of natural HDAC inhibitors, their representatives and premier sources Cyclic tetrapeptides of natural origin and their importance as cancer chemotherapeutic agents Hydroxamates and depsipeptides from natural sources and their promising role in cancer therapy Natural Flavonoids, their HDAC inhibitory tendency and marvellous anticancer activity Non-flavonoid natural HDAC inhibitors and their pleasing cytotoxic effects towards cancer models Combined therapy involving natural flavonoids with other anticancer molecules for synergistic and additive benefits against cancer models Non-flavonoid HDAC inhibitors and conventional drugs in collaborative mode against aggressive malignancies Nanotechnology based delivery of natural HDAC inhibitors for greater therapeutic efficacy over traditional combinatorial therapy

Key Features: 1. Describes the development of the randomized, controlled trial as the gold standard of proof. 2. Unravels the meaning of "randomized," "double-blind" and "p-values" in a simplified manner for students and clinicians. 3. Contains timeless information on how medical evidence can be understood.

This book covers various aspects of cancer chemoprevention, including an overview of chemoprevention in the process of tumorigenesis; the roles of various phytochemicals, functional foods, and dietary interventions in disease prevention; and techniques such as cancer stem cell targeting, nano-formulations, and so forth. The nutrigenomic and epigenetic effects of natural products at the molecular and genetic levels are also covered alongside their potential for additive and synergistic effect, as well as overcoming drug resistance. The key selling features of the book are as follows: Discusses holistic and comprehensive areas of chemoprevention Includes diverse techniques, such as cancer stem cell targeting, nano-formulations, and nanotechnology-based drug delivery systems Introduces various mechanisms involved in prevention of the diseases, including targeting cancer stem cells Reviews various aspects which can reduce the toxicity and cost of treatment of diseases by alternative medicine Explores various sources, mechanisms, and ways to develop cancer chemopreventive agents with minimal toxicity compared to traditional cancer therapy drugs This book is focused on researchers and graduate students in drug delivery and formulation, nanobiotechnology, cancer chemoprevention, prevention, and therapeutics.

Plant-based medicines and aromatics are increasingly in demand throughout the health sector globally, which involves their use not only for the treatment of diseases, but also as potential therapeutics standards for maintaining good health. Unlike modern medicine, herbal medicines derived from plants have several major advantages, including general absence of serious adverse side effects, long-lasting curative impact, and overall cost-effectiveness. Medicinal plants have become threatened due to their minuscule population size, narrow distribution area, habitat specificity, and destructive way of harvesting, only a few studies have been undertaken on their conservation, ecology and pharmacognosy.

This book examines the fundamental concepts of multimodality small-animal molecular imaging technologies and their numerous applications in biomedical research. Driven primarily by the widespread availability of various small-animal models of human diseases replicating accurately biological and biochemical processes in vivo, this is a relatively new yet rapidly expanding field that has excellent potential to become a powerful tool in biomedical research and drug development. In addition to being a powerful clinical tool, a number of imaging modalities including but not limited to CT, MRI, SPECT and PET are also used in small laboratory animal research to visualize and track certain molecular processes associated with diseases such as cancer, heart disease and neurological disorders in living small animal models of disease. In vivo small-animal imaging is playing a pivotal role in the scientific research paradigm enabling to understand human molecular biology and pathophysiology using, for instance, genetically engineered mice with spontaneous diseases that closely mimic human diseases.

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.

The identification of the role of tumor stroma-the tissue in the surroundings of cancer cells-in cancer development, progression, and metastasis has revolutionized the fields of cancer biology as well as cancer therapeutics. This book provides a comprehensive overview of this rapidly-evolving field including tumor stroma biology, therapeutic targets, molecular imaging, and advanced tumor stroma in vitro models. The book will serve as a handbook for graduate students, postgraduate researchers, pharmaceutical scientists, and biomedical engineers.

Key Features: 1. Presents unconventional waste treatment to increase biotic resource efficiency as against standard crop and forestry residues 2. Focuses on promoting sustainability concept within different kinds of waste biorefinery 3. Discusses various systems like microalgal, poultry and microbial refineries 4. Includes techno-economic analysis for waste streams in biofuel production 5. Covers topics like sewer mining, gas fermentation and food waste management

Explains theory and practical applications of nanomaterials as antiviral agents Reviews upscaling of nanomaterials from laboratory to fabrication stage Illustrates nanocurcumin, silver nanoparticles, and carbon nanoparticles for biomedical applications Highlights role of nanotechnology in effectively combating viral infections and pandemics Includes case studies of specific pharma companies

Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids

The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future. A total of four books are covered under the series of Infectious drug diseases. - Malarial drug delivery systems - Tubercular drug delivery systems - Viral drug delivery systems - Infectious disease drug delivery systems Infectious diseases are the world’s greatest killers that present one of the most significant health and security challenges. Humans have lived with emerging and re-emerging pathogens since before the documented history of civilization. The only determining fact today is - If the situation is “worse” or “better” than in past. The answer is probably “worse”, may be due significant increase in human population, increased cross-continent mobility, imbalanced (stressed) life style, irregular food habits leading to compromised innate immunity and over or under practiced hygiene routine. When the incidence of such a disease in people increases over 20 years or threatens to increase, it is called an “emerging” disease, and a growing number have made watch lists and headlines in nearly every country -like highly pathogenic H5N1 avian influenza, severe acute respiratory syndrome (SARS), Ebola virus, food- and waterborne illnesses, and a range of antimicrobial-resistant bacterial diseases TB. This book addresses current and new therapy developments in treating such infectious diseases, updates on finding new drugs, identification of innovative diagnostic methods, understanding of disease research models and clinical trials performances of new treatment modalities. Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of infectious diseases and related research.

* Innovative clinical trial design * Regulatory approval * Real world evidence

This book draws on medical sociology and science and technology studies to develop a novel conceptual framework for understanding innovation processes, using the case study of deep brain stimulation in paediatric neurology. It addresses key questions, including: How are promising and potentially disruptive new health technologies integrated into busy resource-constrained clinical contexts? What activities are involved in establishing a new clinical service? How do social and cultural forces shape these services, and importantly, how are understandings of 'health' and 'illness' reconfigured in the process? The book explores how the ideals of patient-centred medicine influence innovation in the clinic, and it introduces the concept of patient-centred proto-platforms. It argues that patient-centred innovation can constitute an expansion of medical power, as the clinical gaze is directed not only towards the body but also towards the patient as a social being. This will be an innovative and insightful read for academics and advanced students, as well as health service researchers with an interest in technology adoption processes.

Demonstrates the conditions under which a 2D-LC method should be considered as an alternative to a 1D-LC method. Establishes a sound fundamental basis of the principles of the technique, followed by guidelines for method optimization. Provides a single source for technical knowledge advances and practical guidance described in recent literature. Assists with the initial decision to develop a 2D-LC method. Guides the reader in developing a high-quality method that meets the needs of their application.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Numerous herbal plants are used as an important source of life saving drugs for the world's population. Herbal plants are the natural source of several medicines, mainly due to their secondary metabolites, and have long been in use as medicine in the crude extract form. They are also used to isolate the bioactive compounds in modern medicine and herbal medicine systems. They play an important role in the development, synthesis, and formulation of new drugs. Includes chapters on relevant topics contributed by experts of the subjects to make available a comprehensive treatise with in-depth analysis. Audience - those specifically in herbal plant-based drug formulation - presents biotechnological techniques to obtain the desirable products from some specific herbal plants.

Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs. Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized. Addresses economic and practical considerations, unlike many other technical books. Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies. Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action. The concepts discussed in this book allow for the application of more predictive pharmacological procedures aimed at increasing therapeutic efficacy that will lead to more successful drug development. Chapters logically build upon one another to show how to characterize the pharmacology of any given molecule and allow for more informed predictions of drug effects in all biological systems. New chapters are dedicated to the interdisciplinary drug discovery environment in both industry and academia, and special techniques involved in new drug screening and lead optimization. This edition has been fully revised to address the latest advances and research related to real time kinetic assays, pluridimensional efficacy, signaling bias, irreversible and chemical antagonism, allosterically-induced bias, pharmacokinetics and safety, target and pathway validation, and much more. With numerous valuable chapter summaries, detailed references, practical examples and case studies throughout, Dr. Kenakin successfully navigates a highly complex subject, making it accessible for students, professors, and new researchers working in pharmacology and drug discovery.