y development, their different characteristics, clinical trial design, choice of study population, study design guidelines, estimation of the first dose, study design guidelines, and regulatory agencies shall all be investigated. A conclusion will thus be drawn.
Given the risky and fatal impact of failed drug production in humans, the need to be comprehensively certain of the efficacy, function and overall pharmacological outcomes of a clinical drug is very important. It is against this backdrop that early human exploratory development has been used over the years as the first part of any clinical development phase of a novel compound or clinical drug where the compound or drug is assessed for tolerability, pharmacodynamics, and pharmacokinetics in humans (Jefferis, 2007).
There are number of ways in which mAbs have been noted to be different from conventional small molecule drugs. First, Telling (2004) indicated that there is a major interspecies variation between the use of the two molecule forms. What is more, mAbs exhibit less homogenous biological production process when compared to small molecules. Directly related to the action of the biological production is the fact that the mAb is able to achieve specificity of action during drug development but no such specificity of action is achieved for small molecules (Vorberg et al., 2000). Again, the target toxicity for mAbs have been found to be unspecific as there could be on and off target toxicity, accompanied with a highly complex PK:PD relationship. In terms of the field research that have been performed for these two molecule forms, Treon et al. (2005) argued that mAb has seen a relatively youthful research field, most of which have showed outcomes of rare to no linear dose response. What is more, there is an unpredictable effect on the immune system complex when mAb is used.