Developments in Biological Standardization. Siehe auch: Progress... / Replacement, Reduction and Refinement of Animal Experiments in the Development and Control of Biological Products

In the past, animal experimentation has played an important part in the development and quality control of immunobiological products. These days, however, concern about animal welfare is growing and, consequently, increasing emphasis is placed on the use of in vitro methods. This book reports the proceedings of a symposium held at the Paul Ehrlich Institute in Langen, Germany, in November 1994, at which the application of the three Rs principle - replacement, reduction and refinement of the use of animal experiments - was evaluated and recommendations were given. A review of the history of animal experimentation is followed by reports of various international organizations (including the European Pharmacopoeia and the World Health Organization) about their activities with respect to upholding the three Rs principle. It is shown that significant progress has been made in the last few years in the fields of pyrogen testing, hormones, blood products and vaccines. Several new in vitro methods for potency, efficacy and safety testing of vaccines are presented and discussed. General problems such as harmonization, statistics and validation, serological methods and cell cultures are also addressed. Demonstrating that sound science and animal welfare are not irreconcilable, this volume is a valuable resource for all those concerned with the development and manufacture of biological products.