Early phase clinical trial protocols tend to become more and more complex, focusing on gaining as much scientific insight as possible. Multiple objectives are embedded into one single design.

Today, in addition to safety assessments and pharmacokinetic (PK) sampling, pharmacodynamic (PD) read-outs are nowadays implemented as standard in phase 1 protocols. These PD assessments can come in different forms: blood or other body fluid samples followed by special assays, imaging or specific functional testing.

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