PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY …

dose and subsequent dose escalation schemes in humans; 2) to identify potential target organs for toxicity and for the study of whether such toxicity is reversible; and 3) to identify safety parameters for clinical monitoring. Adherence to the principles presented in this document is intended to improve the quality and consistency of the

  Study, Evaluation, Safety, Dose, Biotechnology, Escalation, Preclinical, Preclinical safety evaluation of biotechnology, Dose escalation