CRED Understanding Clinical Development 2024

11/10/2024

Objectives of clinical pharmacodynamic studies

Proof of Mechanism – demonstrate that target modulation by the drug is relevant to measures of efficacy (from preclinical studies and moving to patients)

Safety – evaluate specific safety concerns through dedicated biomarkers

Guidance for dose selection – based on biomarker response select for highest dose to test or for expected therapeutic dose Exposure-response relationship – establish correlation between drug exposure and efficacy and safety to define the therapeutic window No-effect limits – relevant for drug-drug interaction or pharmacogenomics; the range of variability of drug exposure with sufficient safety and efficacy.

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Mechanisms of Action

Physical Chemistry

Antacids - drugs that neutralize the acids in the stomach. They form a coating over the surface of the stomach and adsorb HCl on their surface.

Chelating agents - drugs used to treat poisoning with various metals. They incorporate or chelate metal ions into inner ring structure and in this way inactivate or neutralize the effects of metals.

Activated receptors directly or indirectly regulate cellular biochemical processes (eg, ion conductance, protein phosphorylation, DNA transcription, enzymatic activity).

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