Ethical Environment and Scientific Rationale Towards InVitro Alternatives to Animal Testing Where Are We Going 251

Horst Spielmann

10.1 Introduction 251

10.2 Legal Framework in Europe for Developing Alternatives to Experimental Animals 252

10.3 Cell and Tissue Culture Systems used in Pharmacology and Toxicology 254

10.4 Drug-Metabolizing Systems 255

10.5 Reductions in Experimental Animal Numbers During the Past Decade in Europe: The Situation in Germany 256

10.6 Reducing Animal Numbers in Regulatory Testing by International Harmonization of Test Guidelines 257

10.7 Harmonization of OECD Guidelines for the Testing of Chemicals 258

10.8 Principles of Scientific Validation: The Amden Validation Workshops 258

10.9 Regulatory Acceptance of the Successfully Validated 3T3 NRU In-Vitro Phototoxicity Test 260

10.10 Use of QSAR and Physico-Chemical Exclusion Rules to Predict Skin Irritation Potential 261

10.11 Alternative Methods Used in the Development and Safety Testing of Drugs, Biologicals, and Medical Devices 262

10.12 The Way Forward 264 References 265

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