Pharmaceutics I & II: Other Books

Weigh pivotal healthcare ethics, law, and public policy issues that resulted in tipping-point legal actions Weighing the ethical considerations in healthcare and drug issues can be emotionally difficult and mentally challenging. Drugs, Ethics, and Quality of Life: Cases and Materials on Ethical, Legal, and Public Policy Dilemmas in Medicine and Pharmacy Practice is a fascinating casebook that clearly discusses the most contentious ethical conflicts that resulted in legal actions. This easy-to-read text provides all sides of controversial real-life cases that provoke spirited debate while teaching the fundamentals of pharmacy law and ethics. The book is a unique exploration into the basic principles of bioethics, end of life care, and drug research. Drugs, Ethics, and Quality of Life explains in detail the concepts of ethics, quality of life, beneficence, nonmaleficence, autonomy, and justice. Recent cases provide illuminating backdrops for the exploration of these concepts, making them easily understood. A special introduction includes important information about ethics and the pharmaceutical code of ethics. Two appendixes provide further opportunities for discussion and the examination of law and decisions, and resources about drug use decisions and situations. This thought-provoking textbook plainly shows the crucial role ethics plays in today's society. Ethical topics explored in Drugs, Ethics, and Quality of Life includes legal cases on: tobacco COX-2 inhibitors medical marijuana the “morning after” pill and other emergency contraceptives pain medications and palliative care drugs physician-assisted suicide drug use in medically futile situations gene therapy Drugs, Ethics, and Quality of Life is valuable, insightful reading as well as a good adjunct text for pharmacy students, pharmacists, medical students, physicians, bioethicists, students interested in bioethics, institutional ethics committee members, and anyone interested in bioethics.

Food and drug law deals with governmental attempts to protect public health and individual welfare in the development and marketing of essential commodities. The materials included in this Third Edition, the organization used, and the issues dealt with reflect this focus. The organization and bibliographic assistance should help frame the pertinent questions and identify many of the relevant sources. The FDA's continuing efforts to come to grips with its regulatory responsibilities comprise a mini-history of American administrative law. Since the 1960's, regulation of food, drugs, and related products has presented some of the most challenging illustrations of the tense interplay between law and science. Because of the growing complexity of its responsibilities and the potential clash between public objectives, the FDA has been forced to experiment with a wide variety of innovative administrative procedures for deciding controversial law-science issues. The story of federal efforts

This NEW 2010 BEST SELLER is a comprehensive, easy-to-study guide to current federal pharmacy law. It is designed to help you review the most important federal statutes and regulations, including the newest changes in the Patient Protection and Affordable Health care Act of 2010 (also known as the Health Care Reform Bill of 2010), Electronic Prescriptions for Controlled Substances (EPCS), Medication Therapy Management (MTM) Program guidelines, Medicare Part D, the Controlled Substance Ordering System (CSOS), new rules for prescribing and dispensing drugs that have restricted distribution systems, the Methamphetamine Anti-proliferation Act (MAPA), new HIPAA regulations, the Dietary Supplement Health and Education Act (DSHEA), modified requirements for labeling herbal products, and much more. This book is designed to assist candidates in preparing for pharmacy law examinations in all states. Also includes over 350 practice federal law questions and answers.

Law and Ethics for Pharmacy Technicians provides a comprehensive overview of pharmacy laws, regulations and ethics as they specifically relate to the purview and practice of the pharmacy technician.

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include: advances in international regulatory requirements, including ICH guidelines and harmonization a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

Drug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.

This Second Edition is an essential guide to preparing for FDA pre-approval inspections--taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval. Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition: chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility

Due to the changing nature of the practice of pharmacy, today's pharmacists, pharmaceutical scientists, and researchers are faced with an increasing amount of ethical dilemmas. Pharmacoethics: A Problem Based Approach not only introduces the current ethical issues, it also provides decision making tools that can be applied to any ethical issue that may arise in the future. The authors have identified seven clinical and research ethical competencies that pharmacists will face in their practice: professional responsibility, patient's rights, privacy and confidentiality, truth telling, reproductive ethics, distributive justice, and research ethics. They present 18 problem-based learning cases drawn from the literature and developed around these competencies. These cases use ill-structured ethical problems to demonstrate the types of dilemmas found in modern pharmaceutical practice and help readers acquire the critical decision making and communication skills they need to deal with them. Unlike most texts that concentrate only on ethical principles and ethical decision-making, this book goes a step further. It demonstrates how to use motivational interviewing techniques to work through difficult ethical situations and attain a positive clinical, behavioral, and social outcome. Exploring issues that range from professional responsibility to patient's rights, Pharmacoethics: A Problem Based Approach provides a framework for developing the critical set of patient-related skills necessary for the practice of pharmacy.

This edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices.

Pharmacotherapy is often limited by the inefficient activity and severe toxicity of drug molecules. Nanotechnology offers a revolutionary and definitive approach for the efficient delivery of drug molecules to non-healthy tissues and cells. This first volume of a series of two volumes analyzes the basics in the development of drug-loaded nanoplatforms, the so-called nanomedicines. Special attention is given to physicochemical engineering, pharmacokinetics, biocompatibility and biodegradability, representative nanoplatforms (based on lipids, polymers, cyclodextrins, metals, carbon, silica, iron oxides, etc.), and advanced nano-engineering strategies for passive, ligand-mediated, and/or stimuli-sensitive drug delivery and release.

This unique text helps students and healthcare professionals master the fundamentals of pharmacokinetics and pharmacodynamics. Written by distinguished international experts, it provides readers with an introduction to the basic principles underlying the establishment and individualization of dosage regimens and their optimal use in drug therapy. Up-to-date examples featuring currently prescribed drugs illustrate how pharmacokinetics and pharmacodynamics relate to contemporary drug therapy. Study problems at the end of each chapter help students and professionals gain a firm grasp of the material covered within the text.

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testinghas been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval--including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs--allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Skin, once thought to be an impenetrable barrier, is an extremely active organ capable of interacting with its environment. Advancements in science combined with the need for diverse drug delivery modalities have introduced a variety of transdermal and intradermal products for existing drugs at a fraction of the cost of new drug development. Commercialization of transdermal drug delivery requires technology from many disciplines beyond pharmaceutical sciences, such as polymer chemistry, adhesion sciences, mass transport, web film coating, printing, and medical technology. A comprehensive discussion of these technologies and practices, Transdermal and Intradermal Delivery of Therapeutic Agents: Application of Physical Technologies covers: Commercial development of devices and products based on transdermal physical enhancement technologiesSelecting optimal enhancement technology for a specific drug molecule using case studies Physicochemical properties and practical commercial considerations related to cost, unmet clinical needs, marketing, or intellectual property protectionTechnologies such as microneedles, iontophoresis, electroporation, and sonophoresis, with examples for delivery of small molecules, cosmeceuticals, proteins, and vaccinesPractical information on experimental procedures and challenges related to skin irritation and safety issues Up-to-date and accessible to researchers and industry experts, this book provides a comprehensive discussion of the physical approaches and practical considerations for the laboratory and marketplace.

Drug Delivery is the latest and most up-to-date text on drug delivery and offers an excellent working foundation for students and clinicians in health professions and graduate students including nursing, pharmacy, medicine, and dentistry, as well as researchers and scientists. Presenting complex content in an organized and concise format, this accessible text provides a detailed overview of drug delivery systems, routes of drug administration and development of various formulations. This text provides a comprehensive review of the cutting edge research being carried out in this field and a focus on the worldwide research on drug delivery and targeting at the molecular, cellular, and organ levels. KEY TOPICSCNS deliveryGene deliveryOcular deliveryWorld-wide research on drug deliveryRecent advances in drug deliveryEach new print textbook includes an access code for the online Companion Website. Some eBooks and electronic versions do not include access to the Companion Website. Access to the Companion Website may also be purchased separately under the RESOURCES tab, FOR STUDENTS.Each new print copy includes access to the Navigate Companion Website including: Chapter Quizzes, Interactive Glossary, Crossword Puzzles , Interactive Flashcards, and Matching Exercises

This authoritative volume explores the fundamental concepts and numerous applications of targeted delivery of drugs to the body. This compilation has been divided into eight sections comprised of the basic principles of drug targeting, disease and organ/organelle-based targeting, passive and active targeting strategies, and various advanced drug delivery tools such as functionalized lipidic, polymeric and inorganic nanocarriers. Together, the twenty-three chapters cover a wide range of topics in the field, including tumor and hepatic targeting, polymer-drug conjugates, nanoemulsion, physical and biophysical characteristics of nanoparticles, and in vivo imaging techniques, among others. The book also examines advanced characterization techniques, regulatory hurdles and toxicity-related issues that are key features for successful commercialization of targeted drug delivery system products. Targeted Drug Delivery is a comprehensive reference guide for drug delivery researchers, both beginners and those already working in the field.

This volume provides a comprehensive overview of the current issues facing scientists working on delivering drugs locally and systemically via the membranes that line the mouth. The book describes the anatomical and physiological challenges of this route for drug delivery and how they impact the design of oral mucosal drug delivery systems. It also provides a detailed description of current oral mucosal drug delivery technologies that overcome these challenges alongside research, development and assessment methods. In 11 authoritative chapters, the book affords an in-depth evaluation of the major issues associated with this route of administration, namely the retention of the drug/product at the site of administration and increasing drug permeability through the oral mucosa.  The book provides insights into the in vitro and in vivo methods available to assess drug permeability and retention, offers solutions on how to improve the permeation of the drugs through the oral mucosa, and explores approaches to prolong drug/product retention at the site of administration. It also indicates future directions in research and product development. Oral Mucosal Drug Delivery and Therapy is a key resource for those wishing to extend their knowledge of this field.

Biological and Pharmaceutical Applications of Nanomaterialspresents 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.

The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics--now fully updated.   Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency Chapters have been revised to reflect the latest clinical perspectives on drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy   The field''s leading text for more than three decades, Applied Biopharmaceutics & Pharmacokinetics gets you up to speed on the basics of the discipline like no other resource. Practical problems and clinical examples with discussions are integrated within each chapter to help you apply principles to patient care and drug consultation situations. In addition, outstanding pedagogy, including chapter objectives, chapter summaries, and FAQs, plus additional application questions, identify and focus on key concepts.    Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharmacokinetics shows you how to use raw data and formulate the pharmacokinetic models and parameters that best describe the process of drug absorption, distribution, and elimination. The book also helps you work with pharmacokinetic and biopharmaceutic parameters to design and evaluate dosage  regimens of drugs. In the seventh edition of this must-have interactive learning tool, most of the chapters are updated to reflect our current understanding of complex issues associated with safe and efficacious drug therapy.     

This detailed volume aims to introduce nanomaterials as a new therapeutic regimen in treating human diseases. Divided into four sections, it explores inorganic nanomaterials, organic nanomaterials, pharmaceutical properties of nanomaterials, and applications of nanomaterials in medicine. Several examples of inorganic and organic nanomaterials are provided to demonstrate how to design and develop nanomaterials for pharmacological purposes. The key pharmaceutical properties, including biocompatibility, tissue interaction, pharmaceutics, and pharmacokinetics of nanomaterials are discussed with a focus on the safety and pharmaceutical considerations of nanomaterials in translational development. The pharmacological applications of nanomaterials are depicted in treating various human diseases, including cancer, cardiovascular diseases, immune disorders, infectious diseases, gastrointestinal disorders, bone diseases, respiratory disorders, and drug delivery. Written for the Methods in Pharmacology and Toxicology series, chapters include the kind of specifics and practical advice that ensures a smooth transition into the lab. Authoritative and enlightening, Nanomaterials in Pharmacology serves as an ideal guide to researchers investigating the potential benefits and risks of nanomaterials in pharmacology in order to avoid the pitfalls and to maximize the potential of this vital field of study.

In the second edition of Pharmaceutical Dosage Forms and Drug Deliverythe authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology, emphasizing the increased attention that the recent spectacular advances in dosage form design and drug delivery, gene therapy, and nanotechnology have brought to the field. Highlights of the Second Edition: Additional author Ajit S. Narang brings an industrial practitioner perspective with increased focus on pharmacy math and statistics, and powders and granules Reorganized into three parts:Introduction, Physicochemical Principles, and Dosage Forms Chapters on pharmaceutical calculations, compounding principles, and powders and granules provide a complete spectrum of application of pharmaceutical principles Expansion of review questions and answers clarifies concepts for students and adds to their grasp of key concepts covered in the chapter Coverage of complexation and protein binding aspects of physical pharmacy includes the basic concepts as well as recent progress in the field Although there are numerous books on the science of pharmaceutics and dosage form design, most cover different areas of the discipline and do not provide an integrated approachto the topics. This book not only provides a singular perspective of the overall field, but it supplies a unified source of information for students, instructors, and professionals.

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.

Long considered the standard for covering chemistry at a high level, PRINCIPLES OF MODERN CHEMISTRY continues to set the standard as the most modern, rigorous, and chemically and mathematically accurate book on the market. This authoritative text features an "atoms first" approach and thoroughly revised chapters on Quantum Mechanics and Molecular Structure (Chapter 6), Electrochemistry (Chapter 17), and Molecular Spectroscopy and Photochemistry (Chapter 20). In addition, the text utilizes mathematically accurate and artistic atomic and molecular orbital art, and is student friendly without compromising its rigor. End-of-chapter learning aids now focus on only the most important key objectives, equations and concepts, making it easier for readers to locate chapter content, while new applications to a wide range of disciplines, such as biology, chemical engineering, biochemistry, and medicine deepen readers' understanding of the relevance of chemistry in today's world.

50 Chemistry Ideas You Really Need to Know is an engaging guide to the world of chemistry. From the molecules that kick-started life itself to nanotechnology, chemistry offers some fascinating insights into our origins, as well as continuing to revolutionize life as we know it.

Pharmacogenetics, Kinetics, and Dynamics for Personalized Medicine provides a primer to understand pharmacogenetics (the study of genetic factors that influence how a drug works) in the applied context of pharmacokinetics (how the body handles a drug) and pharmacodynamics (the effects of a drug on the body). This valuable foundation illuminates how these principles and scientific advances can create optimal individual patient care, that is, "personalized medicine." Through specific drug examples, this resource explores how the genetic constitution of an individual may lead to the need for an altered dose or in some cases alternative drug therapy. Real-world cases highlight the specific relationships between genetics, drug action, and the body's response as well as adverse drug reactions, altered metabolism, and drug efficacy. Ethical issues concerning pharmacogenomics and study design are also discussed in this concise overview.

Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material Provides answers and explanations to test your knowledge Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability

There has been a rapid evolution in the field of inhalation drug therapy, including new drugs, increased regulation and quality control, and strong pressure from generics. Inhalation Drug Therapy brings together the most current inhalation drug research, as well as practical developments and processes, into one essential guide. Focusing on inhalation products and specific equipment and techniques used in manufacturing and quality control, the book balances research with the industrial aspects of creating the drugs, and features a highly regarded author team with both academic and industry experience.

A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology tools, resulting in important advances in drug discovery, particularly in the area of absorption, distribution, metabolism, and excretion (ADME). ADME-Enabling Technologies in Drug Design and Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of available technologies, giving readers the information they need to choose the right tool for a given application, a key requisite for obtaining favorable results in a timely fashion for regulatory filings. With over thirty contributed chapters by an international team of experts, the book provides: A thorough examination of current tools, covering both electronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including key parameters, optimal conditions for intended results, protocols, and case studies Detailed discussion of emerging tools and techniques, from stem cells and genetically modified animal models to imaging technologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology, medicinal chemistry, pharmaceutics, toxicology, and bioanalytical science will find ADME-Enabling Technologies in Drug Design and Development an invaluable guide to the entire drug development process, from discovery to regulatory issues.

This important volume highlights the latest developments and trends in chemistry, biochemistry, and biology. It presents the developments of advanced materials and respective tools to characterize and predict the material properties and behavior. The book provides original, theoretical, and important experimental results that use non-routine methodologies often unfamiliar to the usual readers. The papers on novel applications of more familiar experimental techniques and analyses of chemical, biochemistry, and biological programs indicate the need for new experimental approaches.

The development of new CNS drugs is notoriously difficult. Drugs must reach CNS target sites for action and these sites are protected by a number of barriers, the most important being the blood -brain barrier (BBB). Many factors are therefore critical to consider for CNS drug delivery, e.g. active/passive transport across the BBB, intra-brain distribution, and central/systemic pharmacokinetics, to name a few. Neurological disease and trauma conditions add further complexity because CNS barriers, drug distribution and pharmacokinetics are dynamic and often changed by disease/trauma. Knowledge of all these factors and their interplay in different conditions is of utmost importance for proper CNS drug development and disease treatment. In recent years much information has become available for a better understanding of the many factors important for CNS drug delivery and how they interact to affect drug action. This book describes small and large drug delivery to the brain with an emphasis on the physiology of the BBB and the principles and concepts for drug delivery across the BBB and distribution within the brain. It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, and drug industry perspectives. Therewith, it contributes to an in-depth understanding of the interplay between brain (patho)-physiology and drug characteristics. Furthermore, the content is designed to be both cutting-edge and educational, so that the book can be used in high-level training of academic and industry scientists with full references to original publications.    

FDA Regulatory Affairsis a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that's broadly useful to both business and academia.

Drug Delivery Systems, Second Edition expands upon the previous edition with current, detailed methods and technologies to further study drug delivery. With new chapters on nanobiotechnology techniques, experimental methods and the clinical use for the intrathecal delivery of analgesics. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Drug Delivery Systems, Second Edition will be useful for pharmaceutical scientists as well as well as physicians both in the academic institutions and in the industry.

FDLI's Practical Guide, now in its fifth edition, is widely adopted in food and drug law courses in law schools and graduate regulatory programs. A primer for practitioners that is also broadly accessible to anyone with an interest in FDA-related laws and regulations, this key text has been referenced in judicial opinions, including by the US Supreme Court.