In dose escalating studies, should we proceed to next dose before knowing Pk data of previous dose?
CHP: Short answer is Yes, you can proceed on before you know the PK data but there are other factors the PI must consider. To go on or not to go on is a decision of the PI. She/he may proceed to the next dose without knowing the PK BUT would NOT proceed to the next dose without full safety data. PK data may or may not help one in terms of subject safety and this later must be known before we proceed out the next phase of dose level etc.
