Pre-Clinical: Fargo
We are pleased to introduce pre-clinical and clinical topical dermatopharmacokinetics expertise as part of our expanded portfolio of services. We now offer comprehensive in vitro and in vivo DPK testing services spanning pre-clinical formulation assessments to Phase I human pharmacokinetic studies. When coupled with human safety and efficacy studies, pre-clinical studies can provide the strong initial foundation needed to achieve success on the path toward formulation approval.
Developing
a product?
Start by pre-screening formulations and doses using the in vitro Franz
Cell model. Penetration studies are conducted to measure the rate and
extent of penetration into and absorption by the skin. From such studies,
the optimal formulation can be selected and issues regarding penetration
can be identified and resolved before costly clinical studies are initiated.
Already
have a formulation design?
Information about the rate and extent of delivery derived from in vitro
studies using the Franz Cell model can indicate whether targeted tissue
levels are being achieved. Comparisons to competitor products can also
be carried out using this in vitro model.
Making
a generic formulation?
The Franz Cell model can reveal how a generic formulation compares to
the innovator or can be used to pre-screen innovator lots for selection
for bioequivalence trials. Showing bioequivalence in vitro as a first
step can provide a higher degree of confidence when entering clinical
trials.
In vitro Percutaneous Absorption Studies
We conduct percutaneous absorption studies to:
| • Define kinetics for new topical drugs or drug formulations | ||
| • Compare different formulations and innovator lots for drug or excipient absorption | ||
| • Establish bioequivalence for generic formulations | ||
| • Evaluate skin metabolism or cellular uptake using freshly excised surgical skin samples | ||
| • Assess the role of penetration enhancers or inhibitors on percutaneous absorption | ||
| • Provide information on the barrier function as it relates to: | ||
| - Body site / regional variation (using cadaver skin from any region of the body) | ||
| - Epidermal viability (using fresh surgical skin) | ||
| - Split thickness vs. dermatome vs. isolate stratum corneum | ||
| - Synthetic membranes | ||
| - Fingernails and toenails | ||
| We can also provide study designs: | |||
| • to regulatory standards | |||
| • for dermal safety risk assessment of excipients or toxic compounds | |||
| • | to show equivalence in drug release using the SUPAC Membrane Rate of Release Assay when changes in manufacturing or excipient source must be addressed | ||
Contact
us today to find out how we can address your pre-clinical needs.
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