Locally applied drugs with local or systemic action

Clinical studies on locally applied, locally acting products

PD end points or surrogate testing as well as PK parameters (systemic exposure as a measure of safety, penetration pharmacokinetic, skin stripping)

Intraocular (PD end points, PK, tolerance)

Intranasal (PD end points, PK, tolerance, infrared thermography as surrogate assay)

Digestive system (PD end points, PK)

SKIN:

For skin, beside the classic PD end points studies, different surrogate end points assays have been developed, for example the vasoconstrictor essay (blanching studies, performed with a Minolta 600 Chroma Meter).

Other assessments for products applied on the skin:

  • dermal tolerance
  • irritation
  • sensitization

Clinical studies for locally applied drugs intended for systemic activity

Intranasal : local tolerance, PK, infrared thermography

Lung absorption (PK)

TDS (TransDermal Systems):

– PK (plasma profiles)
– adhesion performance (also assessed with the help of infrared thermography)
– tolerance
– irritation and sensitization studies