Safety Pharmacology Studies

Pre-Clinical Safety Pharmacology Studies (Pharmacology)

Pharmacology studies can be divided into three categories: primary pharmacodynamics, secondary pharmacodynamics and safety pharmacology studies.

Primary Pharmacology Studies

• Investigate the mode of action and/or effects of a substance in relation to its desired therapeutic target

Secondary Pharmacology Studies

• Investigate the mode of action and/or effects of a substance not related to its desired therapeutic target

Safety Pharmacology Studies

• Investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above

Safety pharmacology studies defined as those studies that investigate the potential undesirable pharmacodynamics effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.

Safety Pharmacology: How Important Is It?

• Safety pharmacology issues have a significant impact on CD attrition (both preclinically and during clinical development).
• Data are important for Phase I dose-setting.
• SP studies are a regulatory requirement for IND submissions prior to human exposure.
• There are 3 regulatory guidance documents focusing on safety pharmacology, and several others refer to it.
• The consequences of ‘getting it wrong’ can have dramatic implications.

In Vitro Pharmacology

• Mode-of-Action (MoA) – In vitro cell studies to understand the compound Mode-of-Action. This can include antagonist/agonist characterization, signalling pathway analysis, binding characteristics, internalization of antibodies and much more.
• Functional Assays – Adequate assays to investigate potency and efficacy of your compound, with focus on human disease-relevant systems.

In Vivo Pharmacology

Customized Pharmacodynamics (PD) Models – A good PD model can provide pivotal information for understanding the efficacy, dose-response and time-effects of a drug. PD makers can often continue to serve as early target engagement biomarkers in man.

Pharmacokinetic (PK) Studies – We generate pharmacokinetic profiles in an individual animal, creating high robustness in your data. We can assist you with bioanalysis and ensure the best PK parameter determination using the industry-standard software Phoenix® WinNonlin®.

Modeling of PK/PD Relationships and Dose Predictions – A better understanding of the PK/PD relationship of your compound will provide key information for successful pre-clinical development and clinical design e.g. dose to man prediction etc.

Administration Routes and Proper Formulation – Delivery route and drug formulation is of key importance for success. We perform in vivo studies using most administration routes in rodents, including inhalation. Through close collaboration with formulation experts we can ensure optimal formulation of your drug.

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Shanghai Drug Safety Evaluation Center

Medicilon’s Preclinical Pharmacology Studies