Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Plant diseases are a serious threat to food production. This unique volume provides the fundamental knowledge and practical use of B.subtilis as a promising biocontrol agent. In order to replace chemical pesticides, one possibility is microbial pesticides using safe microbes. Bacillus subtilis is one of several candidates. Screening of the bacterium, the application of plant tests, clarification of its suppressive mechanism to plant pathogens and engineering aspects of suppressive peptides production are presented here. The author illustrates how B. subtilis is far more advantageous than, for example, Pseudomonas in biocontrol and can be considered as an useful candidate. Features: Bacterium B. subtilis suppresses many plant pathogens and is a biocontrol agent to replace chemical pesticides The book presents the bacterium's suppressive mechanism to plant pathogens, and engineering aspects of suppressive peptides production Biological control of plant disease plays an important role in sustainable agricultural production practices and is expected to replace agricultural chemicals

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the 'technology' focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

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). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Generally speaking, quantitative-structure activity relationship (QSAR) is a technique which correlates the biological activities of a set of compounds to their structures using a mathematical equation represented in its general form by Biological Activity = f (x1, ..., xn), where f is a mathematical function and x1, ..., xn are n molecular descriptors. Since the introduction of the initial concept of QSAR in the early 1960s, numerous advances have been introduced into the field transforming it into an essential tool in drug discovery and medicinal chemistry. Quantitative Structure - Activity Relationship: A Practical Approach provides a detailed overview of computational approaches in QSAR studies. It covers the applications of different algorithms in various steps of a QSAR analysis and shows clear examples. Each chapter introduces the tools and software involved. Moreover, challenges and issues which may be faced in any step of the analysis are thoroughly broken down based on the OECD guidelines, enabling the reader to familiarize themselves with potential end results. The book was kept concise, making it suitable for students (pharmacy, chemistry and biological science) and lecturers, as well as researchers in the field.

Nature is an attractive source of therapeutic and preventive compounds, and with such chemical diversity found in millions of species of plants, over 60% of currently used anticancer agents are derived from natural sources. Cancer Inhibitors from Chinese Natural Medicines summarizes new advancements in the experimental and clinical research of a selection of promising cancer inhibitors. It focuses on the latest scientific investigations of 238 Chinese herbs and discusses important aspects, including the types of inhibitors in the herbs, level of potency, mechanisms, and the advances in modification and formulation. Formulations from nano-particulates and immunotoxins in cancer inhibitors are also included in this comprehensive resource.

For the past four decades, University College London has offered a renowned course on receptor pharmacology. Originating from this course, the perennially bestselling Textbook of Receptor Pharmacology has presented in-depth coverage of this rapidly expanding area of research. This third edition continues to combine current understanding of classical quantitative pharmacology and drug-receptor interactions with the basics of receptor structure and signal transduction mechanisms, providing an integrated analysis of the mechanisms of drug action at membrane receptors. The hallmark of this popular text is the uniting of four major approaches to the study of receptors: Molecular investigation of receptor structure Quantitative functional studies of agonists and antagonists Ligand binding Signal transduction at the cell membrane Maintaining the second edition's focus on cell membrane receptors and the immediate signal transduction events at the membrane, this edition includes updated chapters on receptor structure and signal transduction by G-proteins and tyrosine kinases as well as enhancements to the quantitative treatment of drug-receptor interactions. Several chapters contain problems and worked-out solutions, giving students the ability to test their comprehension of the material. Hundreds of diagrams and figures further enhance the text. A time-saving resource and comprehensive learning tool, Textbook of Receptor Pharmacology, Third Edition carries on the tradition of providing in-depth, up-to-date coverage of this critical area that is both fundamental to the science of pharmacology and on the cutting edge of new drug development.

The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

This book covers the recent innovations relating to various bioactive natural products (such as alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, volatile oils, fixed oils, fats and waxes, proteins and peptides, vitamins, marine products, camptothecin, piperines, carvacrol, gedunin, GABA, ginsenosides) and their applications in the pharmaceutical fields related to academic, research and industry.

The pharmaceutical industry recognizes the shift to the use of natural products while also considering the serious concerns that have arisen regarding the claimed efficacy, quality, and safety of these products. This volume showcases how pharmaceutical and nutraceutical compounds from natural products can be used to cure or prevent diseases. The chapters explore the connections between agrochemicals and pharmaceuticals and the use of plants and plant products in the formulation and development of new pharmaceuticals and nutraceuticals.

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

A new generation of technological vaccines protect against many infectious diseases. This book describes synthetic peptide-based vaccine prototypes - the future of vaccination. Production of peptides becomes simple using automatic synthesizers. Peptides are weak immunogen and need adjuvants to provide an effective autoimmune response, which is why peptide antigens are conjugated with biopolymers and loaded with nanoparticles. The book illustrates the use of peptides vaccine systems and makes predictions of future development not only for infectious diseases, but also for cancers and brain diseases such as Alzheimer, Parkinson and psychiatric diseases. Key Features Summarizes current studies on technological vaccines Describes the uses of vaccines for the prevention of brain diseases Reviews the ways different polymers are used to enhance vaccine efficacy

The rich biodiversity of Borneo provides many useful plants for medicinal purposes. Written by experts in the field, Medicinal Plants of Borneo provides a guide and introduction to the medicinal plants from Borneo used traditionally as well as plants whose medicinal uses have been recently discovered. These include anti-HIV plants - such as Calophyllum lanigerum (calanolide A) - and anti-cancer plants - such as Aglaia foveolata (silvestrol). The book also provides information on the relevant medicinal chemistry, such as isolated bioactive compounds and the mechanism of action, where available. FEATURES Discusses the rich experience in the use of medicinal plants and the wide diversity of Borneo's botanical resources Presents plants with medicinal properties from a scientific perspective Provides readers with current information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers a range of chemical, botanical and pharmacological diversities Forms an important part of the Natural Products Chemistry of Global Plants series due to an increasing global interest in natural products and botanical drugs Simon Gibbons is Head of the School of Pharmacy, University of East Anglia, UK, and a Professor of Natural Product Chemistry. He was formerly a Professor of Medicinal Phytochemistry at the School of Pharmacy, University College London (UCL). Stephen P. Teo is a forest botanist with the Forest Department, Sarawak, Malaysia.

This book combines discursive chapters that present the latest progress in molecular biology, drug discovery, organ-tissue engineering, and related fields, with a number of descriptive chapters on methods, protocols, and case studies. Structured into four parts, this volume walks the reader through the latest in cellular biology, with discussions on novel medicinal plant metabolites, nanotechnology in precision medicine, nucleic acid-based therapeutics and vaccines, genetic engineering, computational aid, bioinformatics, synthetic organs for transplantation, and organ-tissue engineering. Written for the highly successful Methods in Molecular Biology series, chapters include the kind of detail and expert implementation advice that ensures quality results in the lab. Authoritative and informative, Gene, Drug, and Tissue Engineering serves as an ideal guide for undergraduate students, postgraduate researchers, and senior researchers working in biomedicine and its underlying technologies, stimulating both computational and experimental development and fostering the exchange of new ideas.

Medicinal Chemistry of Neglected and Tropical Diseases: Advances in the Design and Synthesis of Antimicrobial Agents consolidates and describes modern drug discovery and development approaches currently employed to identify effective chemotherapeutic agents for the treatment of Neglected Tropical Diseases (NTDs) from a medicinal chemistry perspective. Chapters are designed to cater to the needs of medicinal chemists who work with chemotherapeutic developments for NTDs, as well as serve as a guide to budding medicinal chemists who wish to work in this area. It will introduce rational drug design approaches adopted in designing chemotherapeutics and validated targets available for the purpose.

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition. Key Features: Continues to be the definitive reference on drug metabolism Covers the drug transporter field, disposition of protein therapeutics and metabolic activation of drugs Includes the contributions of world-class experts in their respective fields Contains the work of editors who are recognized leaders and deep content experts in the field of drug metabolism Emphasizes new scientific and regulatory developments in the field

The purpose of this book is to focus on major considerations in the clinical use of botanicals as an integrated therapy in current health care. The book uses an organ system approach to presenting clinical evidence on the use of botanicals for common conditions. The chapters include brief sections on background and pharmacognosy, preparation and dosing, safety, evidence and clinical application. In addition, several chapters highlight pharmacokinetic and pharmacogenomic considerations with botanicals in precision medicine and their use in special populations. Finally, a summary on the editors' perspective of "challenges and opportunities" is provided, which discusses the practice of botanicals as integrative therapies and where they are heading in the future.

Ethnobotany includes the traditional use of plants in different fields like medicine and agriculture. This book incorporates important studies based on ethnobotany of different geographic zones. The book covers medicinaland aromatic plants, ethnopharmacology, bioactive molecules, plants used in cancer, hypertension, disorders of the central nervous system, and also as antipsoriatic, antibacterial, antioxidant, antiurolithiatic. The book will be useful for a diverse group of readers including plant scientists, pharmacologists, clinicians, herbalists, natural therapy experts, chemists, microbiologists, NGOs and those who are interested in traditional therapies.

The field of molecular medicine covers the medical interventions targeting molecular structures and mechanisms that are involved in disease progression. In cancer, several molecular mechanisms have been shown to impact its progression, aggressiveness and chemoresistance. Increasing evidence demonstrates the role of nanotechnology and outcome of molecular therapy. Several books have discussed molecular biology and mechanisms involved in cancer, but this text gives an account of molecular therapeutics in cancer relating to advancements of nanotechnology. It provides a description of the multidisciplinary field of molecular medicines and its targeted delivery to cancer using nanotechnology. Key Features: Provides current information in the multidisciplinary field of molecular medicines and its targeted delivery to cancer using nanotechnology Presents important aspects of nanotechnology in the site-specific delivery of anticancer agents Includes up to date information on oligonucleotide and gene based therapies in cancer Describes small targeted molecules, antibodies and oligonucleotides which have shown to selectively target the molecular structures thereby influencing signal transduction Facilitates discussion between researchers involved in cancer therapy and nanoscientists

Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years. Research in Ayurveda is now a world-wide phenomenon, and several large pharmaceutical corporations are investing money for novel drug discovery from Ayurvedic sources. This book examines the regulatory and pharmacological aspects and includes extensive data on scientific evaluation carried out on Ayurvedic formulations. It will also serve as a reference book on standardization, pre-clinical studies, and clinical and toxicological studies on Ayurvedic formulations.

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors