Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. The rapid pace of discovery in the biotechnological sciences has created substantial difficulties for the Federal food and Drug Administration (FDA), European Union and all major regulators, which ensures the safety and efficacy of biopharmaceutical products. The speed of biotechnological discovery necessarily requires rapid product approval by regulators, as...

Animals have been in use in the drug research and development process in lieu of providing safety and efficacy data in the past several decades, especially after the thalidomide and sulphanilamide tragedies. But due to various reasons like continuous pressure from animal welfare groups all over the world and continuous advancements in the field of non-animal alternative testing strategies, demand for substitution of animals to ascertain drug safety is catching momentum. The 3R'principle i.e. reduction, refinement and replacement approach has become the motto of humane treatment towards...