ABSTRACT
This chapter reviews methods used to assess the risk and benefit of a candidate biotechnology product, with emphasis on biopharmaceuticals, as performed in nonclinical laboratory and animal studies. Nonclinical studies, performed in vitro and in animals, are primary means of measuring the potential product risk, and much of this testing precedes clinical trials. Nonclinical testing of biopharmaceuticals has its foundation in the drug industry, where a general understanding and appreciation for the value of pharmacology and toxicology have led to successful development and marketing of small molecule drugs. A concept nonclinical study design, once found acceptable to a product development team, is then written further in a nonclinical study design document, that is, the protocol. Adequate and well-controlled nonclinical study designs have common elements, no matter how the study is classified, and each element is considered in the study protocol.
