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.

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

All medicinal products have to be licensed before marketing in any of the EEC, Nordic and EFTA countries. This book provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change with the creation of a single European market in pharmaceuticals after 1992. The book should be of value to the pharmaceutical industry and their suppliers (the bulk excipient and active substance manufacturers); to government regulatory agencies; and to members of many technical, professional, scientific, medical and regulatory societies and organizations concerned directly and indirectly with medicinal products - particularly to members of the pharmaceutical and medical professions. There is an enormous interest in this subject in the EEC, the USA and Japan due to the likelihood of the creation in 1992 of a single market with some 350,000 patients.

A HISTORY OF THE MEDICINES WE TAKE gives a lively account of 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 to the latest biotechnology antibody products. The first ten chapters of the book in PART ONE give an account of the development of the active drugs from herbs used in early medicine, many of which are still in use, to the synthetic chemical drugs and modern biotechnology products. The remaining eight chapters in PART TWO tell the story of the developments in the preparations that patients take and their inventors, such as Christopher Wren, who gave the first intravenous injection in 1656, and William Brockedon who invented the tablet in 1843\. The book traces 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. Today nearly three-quarters of medicines dispensed to patients are tablets and capsules. A typical pharmacy now dispenses about as many prescriptions in a working day as a mid-nineteenth- century chemist did in a whole year.