The British Pharmacopoeia has provided official standards for the quality of substances, medicinal products and articles used in medicine since its first publication in 1864. It is used in over 100 countries and remains an essential global reference in pharmaceutical research and development and quality control. This book explores how these standards have been achieved through a comprehensive review of the history and development of the pharmacopoeias in the UK, from the early London, Edinburgh and Dublin national pharmacopoeias to the creation of the British Pharmacopoeia and its evolution over 150 years. Trade in medicinal substances and products has always been global, and the British Pharmacopoeia is placed in its global context as an instrument of the British Empire as it first sought to cover the needs of countries such as India and latterly as part of its role in international harmonisation of standards in Europe and elsewhere. The changing contents of the pharmacopoeias over this period reflect the changes in medical practice and the development of dosage forms from products dispensed by pharmacists to commercially manufactured products, from tinctures to the latest monoclonal antibody products. The book will be of equal value to historians of medicine and pharmacy as to practitioners of medicine, pharmacy and pharmaceutical analytical chemistry.

The word "pharmacopoeia" has come to have many meanings, although it is commonly understood to be a book describing approved compositions and standards for drugs. In 1813 the Royal College of Physicians of London considered a proposal to develop an imperial British pharmacopoeia – at a time when separate official pharmacopoeias existed for England, Scotland, and Ireland. A unified British pharmacopoeia was published in 1864, and by 1914 it was considered suitable for the whole Empire. Pharmacopoeias, Drug Regulation, and Empires traces the 350-year development of officially sanctioned pharmacopoeias across the British Empire, first from local to national pharmacopoeias, and later to a standardized pharmacopoeia that would apply throughout Britain’s imperial world. The evolution of British pharmacopoeias and the professionalization of medicine saw developments including a transition from Galenic principles to germ theory, and a shift from plant-based to chemical medicines. While other colonial powers in Europe usually imposed metropolitan pharmacopoeias across their colonies, Britain consulted with practitioners throughout its Empire. As the scope of the pharmacopoeia widened, the process of agreeing upon drug standardization became more complex and fraught. A wide range of issues was exposed, from bioprospecting and the inclusion of indigenous medicines in pharmacopoeias, to adulteration and demands for the substitution of pharmacopoeial drugs with locally available ones. Pharmacopoeias, Drug Regulation, and Empires uses the evolution of an imperial pharmacopoeia in Britain as a vehicle for exploring the hegemonic power of European colonial powers in the medical field, and the meaning of pharmacopoeia more broadly.

Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products - Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. - Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).

Reprint of the original. The publishing house Anatiposi publishes historical books as reprints. Due to their age, these books may have missing pages or inferior quality. Our aim is to preserve these books and make them available to the public so that they do not get lost.

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies

This remarkable new book is the first text dedicated to the topic of pharmacovigilance for herbal and traditional medicines. Taking a truly global perspective, this volume draws together contributions from a diverse group of experts, writing on current knowledge and practices in pharmacovigilance for herbal and traditional medicines, and on advances and innovation in monitoring the safety of this unique and complex category of products and preparations. In part one, the book discusses the current status of pharmacovigilance for herbal and traditional medicines, including the importance of natural products chemistry to harms, and its relevance in considering how pharmacovigilance for these products could be undertaken. Several other chapters discuss methodological approaches and ongoing challenges in pharmacovigilance for herbal and traditional medicines, including issues relating to nomenclature, coding and classification, and the nuances involved in causality assessment. Part two of the book focusses on pharmacovigilance for herbal and traditional medicines around the world, with chapters from authors in several different countries representing diverse historical, ethnic, cultural, social and political contexts. These chapters provide deeper insights and perspectives into spontaneous reporting for herbal and traditional medicines in those countries, and in the context of the local use, practice and regulatory landscape for these products. Part two also provides an overview and new analysis of international case safety reports for herbal medicines held in VigiBase (the World Health Organization's global database of individual case safety reports, maintained by the Uppsala Monitoring Centre). This book is aimed at pharmacists, doctors, nurses and other health professionals, herbal-medicine practitioners and organisations, herbal medicine and pharmaceutical industry personnel, pharmacovigilance specialists, medicines’ regulators, health and social science researchers and academics, pharmacovigilance and health professional students, and students of herbal and traditional medicine, throughout the world. It is an extremely valuable resource for all individuals whose work touches the intersection between herbal medicines and pharmacovigilance, and it provides both an introduction to the topic and a deeper, comprehensive, contemporary account of the topic.

A fascinating account of poultices, pills, and prescriptions over the centuries and how they’ve been developed and delivered. This lively account follows the development of medicines from traces of herbs found with the remains of Neanderthal man, to prescriptions written on clay tablets from Mesopotamia in the third millennium BC, to pure drugs extracted from plants in the nineteenth century, and to the latest biotechnology antibody products. In addition, it tells the stories behind historical figures in medicine, such as Christopher Wren, who gave the first intravenous injection in 1656, and William Brockedon, who invented the tablet in 1843, as well as recounting the changes in patterns of prescribing from simple dosage forms—such as liquid mixtures, pills, ointments, lotions, poultices, powders for treating wounds, inhalations, eye drops, enemas, pessaries, and suppositories mentioned in the Egyptian Ebers papyrus of 1550 BCE—to the complex tablets, injections, and inhalers in current use. A typical pharmacy now dispenses about as many prescriptions in a working day as a mid-nineteenth-century chemist did in a whole year. This history sheds light on the scientific progress made over centuries that led to the medical miracles of the modern world.

Antimalarial Agents: Design and Mechanism of Action seeks to support medicinal chemists in their work toward antimalarial solutions, providing practical guidance on past and current developments and highlighting promising leads for the future. Malaria is a deadly disease which threatens half of the world's population. Advances over several decades have seen vast improvements in the eff ectiveness of both preventative measures and treatments, but the rapid adaptability of the disease means that the ongoing search for improved and novel antimalarial drugs is essential. Beginning with a historical overview of malaria and antimalarial research, this book goes on to describe the biological aspects of malaria, highlighting the lifecycle of the parasite responsible for malaria, the problem of resistance, genetic mapping of the parasite's genome, established drug targets, and potential drug targets for the future. This sets the scene for the following chapters which provide a detailed study of the medicinal chemistry of antimalarial agents, with a focus on the design of antimalarial drugs. Drawing on the knowledge of its experienced authors, and coupling historic research with current fi ndings to provide a full picture of both past and current milestones, Antimalarial Agents: Design and Mechanism of Action is a comprehensive yet accessible guide for all those involved in the design, development, and administration of antimalarial drugs, including student academic researchers, medicinal chemists, malaria researchers, and pharmaceutical scientists.