PSC646 - Regulatory Science: Books

USP–NF is your trusted guide through the pharmaceutical process. It’s your source for FDA-enforceable quality standards for drugs, dietary supplements, excipients, procedures for tests, assays, analytical methods, and more.

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.

Focusing on the new drug approval process, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition, examines cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements, and the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human, drug, and device development, research, manufacturing, and marketing.

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.

This edition's introduction includes timely information on general strategies for drug usage, the science of drug discovery and development, economic and regulatory aspects of cancer drug development, and principles of pharmacokinetics. A companion website includes the fully searchable text and an image bank.