tailieunhanh - BIOPHARMACEUTICALS BIOCHEMISTRY AND BIOTECHNOLOGY - PART 3

Các sản phẩm được liệt kê trong các pharmacopoeias quốc tế không thay đổi loại thuốc generic (nghĩa là thuốc không còn được bảo vệ bằng sáng chế, có thể được sản xuất tại bất kỳ cơ sở dược phẩm giữ giấy phép sản xuất thích hợp). Số lượng lớn lớn các chất đó là loại thuốc hóa chất truyền thống, và các chất sinh học như insulin và các sản phẩm máu khác nhau. | 94 BIOPHARMACEUTICALS manufactured to exacting specifications laid down in publications termed pharmacopoeias . There are more than two dozen pharmacopoeias published world-wide most notably the United States Pharmacopoeia USP the European Pharmacopoeia Eur. Ph. and the Japanese Pharmacopoeia. The products listed in these international pharmacopoeias are invariably generic drugs . drugs no longer patent-protected which can be manufactured in any pharmaceutical facility holding the appropriate manufacturing licence . The vast bulk of such substances are traditional chemical-based drugs and biological substances such as insulin and various blood products. Two sample monographs from the European Pharmacopoeia are reproduced in Appendix 3. Future editions of such pharmacopoeias are likely to include a growing number of biopharmaceuticals particularly as many of these begin to lose their patent protection. Martindale The Extra Pharmacopoeia Martindale The Extra Pharmacopoeia often simply referred to as Martindale represents an additional publication of relevance to the pharmaceutical industry. Unlike the pharmacopoeias discussed above Martindale is not a book of standards. The aim of this encyclopaedic publication is to provide concise unbiased information largely summarized from the peer-reviewed literature regarding drugs of clinical interest. The first edition of Martindale was published in 1883 by William Martindale and the 30th edition was published in 1993. It contains information in monograph format on over 5000 drugs in clinical use. The vast bulk of substances described are chemical-based pharmaceuticals as well as traditional biological substances such as antibiotics certain hormones and blood products. Recent editions however carry increasing numbers of monographs detailing biopharmaceuticals a reflection of their growing importance in the pharmaceutical industry. Martindale is largely organized into chapters that detail groups of drugs having similar .