Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

The volume sheds new light on role of gut dysbiosis in cancer and immunological diseases and their clinical manifestations. Contributions in the volume discuss about the gut microbiota as a therapeutic target and the role of probiotics in its management. The volume explores application of probiotics in the treatment of various cancers viz. colorectal, gastric, lung, and breast cancer and immunological diseases. The volume comprises of chapters from expert contributors organized into various important themes which include, introduction, relationship between gut microbiota and disease condition, mechanisms involved, clinical and in vivo status, conclusion and future directions. This is a highly informative and carefully presented book, providing recent and innovative insight for scholars and researchers with an interest in probiotics and its applications in cancer and immunological diseases.

The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.

Planar Chromatography-Mass Spectrometry focuses on a relatively new approach to chemical analysis in general, and to separation science in particular. It is the first book to systemically cover the theoretical background, techniques, instrumentation, and practical applications of planar chromatography-mass spectrometry as a hyphenated tool of analytical chemistry. It also examines the high and as-yet unexploited potential of planar chromatography-mass spectrometry for analytical use in scientific investigations. This book overviews the combination of planar chromatography, a relatively simple and cost-effective separation step for determining complex mixtures of compounds, with mass spectrometry, an efficient, highly instrumental, and relatively expensive technique that enables rapid identification of separated chemical species. It covers electrophoretic-mass spectrometry methods and applications, which are considered planar chromatographic techniques and are increasingly being exploited in proteomic and molecular biology studies as well as for medical diagnostic purposes. It also provides a selection of applications, such as drug control and forensic and food analysis, including more difficult substances such as carbohydrates and lipids. The book advocates growth in using planar chromatography-mass spectrometry in laboratories that have appropriate equipment but have not yet employed the techniques in combination. It also describes the use of a relatively inexpensive commercial system that can be adopted by laboratories currently working without the coupled methodology. Aiming to improve power and efficiency when other analytical methods are inadequate, Planar Chromatography-Mass Spectrometry encourages separation science practitioners in academia and industry to combine the two methods for enhanced results.

Hugo Chavez won re-election in the 2012 Venezuelan presidential election, despite a closer margin between candidates than in previous elections. The results were puzzling for those who believed that Chavez's government had long ago reached its limits, while Chavez's supporters were struck by the growth of the opposition vote. Thus understanding the Venezuelan election of 2012 has proved to be challenging, with various recent studies focused upon it. Luis F. Angosto Ferrandez's book advances two ideas not previously discussed: the relationship between electoral behavior in Venezuela and contemporary Latin American geopolitics, and the way that relationship is projected through the candidates' appeal to narratives that situate Venezuela at the core of a heroic Latin American tradition and of a new regional process of integration. This edited volume first contextualizes and explains the results of the last re-election of Hugo Chavez in terms of its geopolitical conditionings and implications. Contributors tackle Latin American geopolitics by analyzing Venezuelan foreign policy and the country's role in continental projects of supra-national integration. Contributors also examine electoral strategy and tactics in order to show how the two main candidates built their campaign on emotional grounds as much on rational ones. This will be connected to the investigation of new narratives of national identification in contemporary Venezuela and how they may have practical implications in the design of policies addressing issues such as indigenous rights, community media and national security. Compiling state-of-the-art research on Latin American and Venezuelan politics, this book will appeal to academics and professionals who specialize in Latin American studies, international relations, democracy, and indigenous peoples.

Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.

Explore Important Tools for High-Quality Work in Pharmaceutical Safety Statistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approaches, such as the use of marginal structural models for controlling dynamic selection bias in the analysis of large-scale longitudinal observational data. Choose the Right Statistical Approach for Analyzing Your Drug Safety Data The book describes linear and non-linear mixed-effects models, discrete-time survival models, and new approaches to the meta-analysis of rare binary adverse events. It explores research involving the re-analysis of complete longitudinal patient records from randomized clinical trials. The book discusses causal inference models, including propensity score matching, marginal structural models, and differential effects, as well as mixed-effects Poisson regression models for analyzing ecological data, such as county-level adverse event rates. The authors also cover numerous other methods useful for the analysis of within-subject and between-subject variation in adverse events abstracted from large-scale medical claims databases, electronic health records, and additional observational data streams. Advance Statistical Practice in Pharmacoepidemiology Authored by two professors at the forefront of developing new statistical methodologies to address pharmacoepidemiologic problems, this book provides a cohesive compendium of statistical methods that pharmacoepidemiologists can readily use in their work. It also encourages statistical scientists to develop new methods that go beyond the foundation covered in the text.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

The structural complexity and the synthetic challenges facing glycans have historically hampered efforts to study their multifaceted roles and the application of carbohydrates in drug development. However, in very recent years, new synthetic techniques flanked by the growing knowledge about carbohydrate involvement in physiological and pathological states has spurred renewed interest in the chemistry, biology and therapeutic potentialities of carbohydrates. This book offers an overview of key aspects of carbohydrate biology and chemistry that are fundamental for the design of novel therapeutics. The four-part structure of this book introduces these essential components to life, starting from their structure and biological roles and covering analytical methods and synthesis which pave the way for the development of a wide range of therapeutic applications.Leading experts from around the world are brought together to offer their recent research with the ultimate aim of enlightening the reader on the complex yet exciting field of carbohydrate chemistry. Academic and industrial researchers in structural biology, drug discovery and carbohydrate chemistry will find this book an essential guide to the latest research and future potential of medicinal chemistry.

Analytical ultracentrifugation (AUC) can supply rich information on the mass, shape, size distribution, solvation, and composition of macromolecules and nanoscopic particles. It also provides a detailed view of their reversible single- or multi-component interactions over a wide range of affinities. Yet this powerful technique has been hard to master in mainstream molecular sciences due to a lack of comprehensive books on the subject. Filling this gap in the literature of biophysical methodology, Basic Principles of Analytical Ultracentrifugation explains the fundamentals in the theory and practice of AUC. The book provides you with up-to-date experimental information to confidently practice AUC. You will understand the basic concepts, full potential, and possible pitfalls of AUC as well as appreciate the current relevance of past work in the field. The book first introduces the basic principles and technical setup of an AUC experiment and briefly describes the optical systems used for detection. It then explores the ultracentrifugation experiment from a macromolecular standpoint, offering a detailed physical picture of the sedimentation process and relevant macromolecular parameters. The authors present important practical aspects for conducting an experiment, including sample preparation, data acquisition and data structure, and the execution of the centrifugal experiment. They also cover instrument calibration and quality control experiments.

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Describes the thermodynamics and kinetics underlying hydrophobic interaction chromatography of proteins. Outlines use of a kinetic model in the predictive modeling of evaporation processes that eliminates the need to know the composition and identity of the chemical constituents in the sample. Explores building and employing QSRR models in cyclodextrin modified high-performance liquid chromatography (HPLC). Reviews chemometric methods commonly paired with comprehensive 2D separations and key instrumental and preprocessing considerations.

Provides academic introduction to the uses of nanotechnology in drug delivery Discusses use of nanomaterials in targeting a drug to specific tissues and cells Presents an analysis of clinical status for different types of Nano platforms Covers applications in drug delivery, therapy, and engineering Focus on how novel nanotechnology orientated methods can help improve treatment

In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design. Its main aims are to introduce the theoretical framework and algorithms, discuss the range of validity, strengths and limitations of each methodology, and present applications to real world problems in the drug discovery arena. Special emphasis has been given to the emerging and most pressing methodological challenges in in silico drug discovery and design. The book assumes a basic knowledge of physical principles and molecular modeling. Particular attention has been paid to outline the underlying physico-chemical foundation of the methods described, thus providing the necessary background to avoid a "black-box" approach. In each self-contained chapter, this is presented together with the latest developments and applications, and the challenges that lie ahead. Assembling a unique team of experts to weigh in on the most important issues influencing modern computational drug discovery and design, this book constitutes both a desktop reference to academic and industrial researchers in the field, and a textbook for students in the area of molecular modeling and drug discovery. Comprised of 18 chapters and divided into three parts, this book: Provides a comprehensive, unified, and in-depth overview of the current methodological strategies in computer-aided drug discovery and design Outlines the underlying physico-chemical foundation of the methods described Presents several applications of computational methods to real world problems in the drug design field Helps to avoid a "black-box" approach to in silico drug discovery Constitutes an actual textbook for students in the area of molecular modeling and drug discovery Gives the reader the adequate background to face the current challenges of the field In Silico Drug Discovery and Design: Theory, Methods, Challenges, and Applications describes the theoretical framework, methods, practical applications and case examples relevant to computer-aided drug lead discovery and design. This text will surely aid in understanding the underlying physical foundation of computational tools and their range of application, thus facilitating the interpretation of simulation results.

Timely coverage of cleaning validation for the phamaceutical industry, a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based approaches to cleaning validation. Draws on the author's vast experience in the field of cleaning validation and hazardous materials Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products

Presents health benefits and medicinal importance of dietary polyphenols having antioxidative effects and their possible preventive role against oxidative stress (OS)-induced chronic human diseases Summarizes latest understanding on the biochemical mechanism(s) involved in the antioxidative action of dietary polyphenols along with their bioavailability, pharmacokinetic, and toxicological considerations Highlights novel approaches of drug discovery from dietary polyphenols through computational screening of bioactive phytochemical components

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. * Unique volume covering FDA inspections of GLP facilities * Provides a detailed interpretation of GLP Regulations * Presents the latest on electronic data management in GLP * Describes GLP and computer systems validation * Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. * First book of its kind focusing strictly on CMC Bayesian case studies * Case studies with code and output * Representation from several companies across the industry as well as academia * Authors are leading and well-known Bayesian statisticians in the CMC field * Accompanying website with code for reproducibility * Reflective of real-life industry applications/problems

Biological and Pharmaceutical Applications of Nanomaterials presents the findings of cutting-edge research activities in the field of nanomaterials, with a particular emphasis on biological and pharmaceutical applications. Divided into four sections-nanomaterials for drug delivery, antimicrobial nanomaterials, nanomaterials in biosensors, and safety of nanomaterials-this book: Covers topics such as stimuli-responsive nanostructured silica matrixes, gold nanoparticles, and liposomes for targeting drug delivery and dental applications Describes the use of nanocarriers and nanoparticles as cancer and peptide therapeutics, the influence of surface characteristics on microbial adhesion, and the latest developments in antimicrobial nanostructured polymers for medical applications Discusses recent advances in nanodiagnostic techniques for infectious agents, chromogenic biosensors for pathogen detection, electrochemical biosensors for detecting DNA damage and genotoxicity, and molecular imaging with quantum dots including surface modifications by polymers for biosensing applications Featuring contributions from field experts and researchers in industry and academia, Biological and Pharmaceutical Applications of Nanomaterials provides state-of-the-art information on nanomaterials and their use in drug delivery, infection control, and biomedicine.

Gives a convenient summary of trials in Gynecologic Oncology Supplies an invaluable revision primer for those undertaking certification Provides a uniquely up-to-date resource

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide "one stop shopping" for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

This volume on applied pharmaceutical science and microbiology looks at the latest research on the applications of natural products for drug uses. It focuses on understanding how to apply the principles of novel green chemistry methods in the vital area of pharmaceuticals and covers the important aspects of green microbial technology in the pharmaceutical industry. Chapters include studies on the applications of natural products used in folk and regional medicines, such as for digestive problems, dermatological infections, respiratory diseases, vessel diseases, diarrhea and dysentery, ringworms, boils, fevers (antipyretic), skin and blood diseases, mouth sores, channel discharges, and even cancer. The volume also looks at medical benefit of microbial fermentation for the conservation of nutrients.

Features Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials Describes the up-to-date theory and practice for model-assisted designs Presents many practical challenges and issues arising from early-phase clinical trials Illustrates with many real trial applications Offers numerous tips and guidance on designing dose finding and optimization trials Provides step-by-step illustration of using software to design trials Develops a companion website (www.trialdesign.org) to provide easy-to-use software to assist learning and implementing model-assisted designs.

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.