HPR – Human Pharmacodynamics

30 Years Experience with Proof of Concept (PoC) Studies
in Human Pain Research – using
Human Pharmacodynamic (Laser) Algesimetry

Algesimetric measurements

using Laser-Evoked Potentials >LEPs< from different skin types (for INDs, Rx, generics, OTCs) in oral, parenteral & topical administration modes

EFNS guidelines (Europ J Neurol 2010) …  laser-evoked potentials (LEPs) are the easiest and most reliable of the neurophysiological methods for assessing function of nociceptive pathways …

The Approach

  • Multiple intra-individual cross-over designs
  • 2- up to 6-way crossover trial paradigms
  • With different skin conditions in the same trial

Time and Cost Aspects

  • Programmed saving with regard to both aspects
  • Full-service-testing of diverse nociceptive conditions – within one setting
  • Minor pool of participants (e.g. about 16 to 24 subjects only)

Study Conduct

  • Experimental part in well-defined time-lines
  • E.g. 6-way (single-dose) trial in 6 weeks + Screening and ESV period (of 1 week each)
  • 2 weeks for statistics and first results from up to 2300 LEP sessions per study
  • Realtime recording and pre-analysis during study

The Settings

  • Laser Evoked Potentials (LEPs) from normal and sensitized skin
    (e.g. UVB-irradiation and capsaicin-irritation)
  • Psychophysics, electronic (pain) VAS, QST & quantitative skin colorimetry
  • Use of healthy volunteers

Validity & Comparability

  • High – due to sophisticated (objective-quantitative) test paradigms and due to a high expertise with references to former studies in many other experimental and marketed analgesic compounds and similars – resulting in a large data base (>50 compounds), done with the same or similar settings for comparisons – over 30 years now


Invited Speaker at NIH Workshop:
Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain

Emerging Tools and Approaches in Biomarker Discovery and Development

Predictive validity of human Laser-EPs in extended phase-I IND analgesic research

Look Video Cast of NIH Pain Workshop in Washington DC:
Link: https://videocast.nih.gov/summary.asp?Live=28514&bhcp=1

Start looking from 1:25h for presentation Day 2 Nov 15th 2018
(about 20min, Dr.K.Schaffler HPR – Discussion later)