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Pharmacodynamic Expertise

The identification of clinical effective drug candidates in the early clinical trial conduct is the key benefit of biomarkers. Due to changes in biomarker patterns it is possible to distinguish between effective and ineffective drug therapy, which enables “go/no-go” decisions for the clinical drug development programmes of our clients combined with time and cost savings. CRS has experience in the implementation and analysis of diverse biological markers in various areas including Hormones, Cardiovascular, CNS, Immunology, Lipids, Hemostasis and Haematology. A large panel of techniques to measure biomarkers/PD-parameters is built up continuously by CRS. In the following an exemplary list of techniques is shown. For further information, please feel free to contact CRS directly.

Cardiovascular / Angiology

Non-invasive

  • Impedance cardiography
  • Vascular ultrasound diagnostics including
    • Flow mediated dilatation (FMD)
    • Intima media thickness (IMT)
  • Skin Laser Doppler with
    • Acetylcholine iontophoresis
    • Nitric oxide iontophoresis
    • Postischaemic response
  • Laser speckle contrast imaging (LASCA)
  • Venous occlusion plethysmography
  • Arterial tonometry with the assessment of
    • AiX@75
    • Pulse wave velocity
  • 24 hour blood pressure monitoring
  • 24 hour holter monitoring
  • Blood coagulation (Hemochron®)
  • Cardiovascular autonomic function testing (Heart Rate Variability)

Invasive in collaborations with external specialists

  • Radiologic Diagnostic supported by Neuroradiology and MRT
  • Imaging: SPECT (CBF), PET (FDG, C11), fMRI
  • Invasive cardiac catheter investigations
Cognition / Stress tests
  • Cognitive test battery (Psychomotor performance, attention & vigilance, short/long term memory testing, subjective evaluation)
  • Anxiety models
  • Columbia Suicide Severity Rating Scale Scoring
  • Strest tests, Trier Social Stress Test (Daacro®)
  • Psychometric testing
  • Cognition & vigilance testing (Vienna Determination Test System, CDR), validated questionnaires, Visual Analogue Scales, computerized pupillometry - static and dynamic)
Dermatology
  • Skin perfusion: Laser Scanner Doppler (LSD)
  • Sweat Tests
  • Skin lesion quantification in atopic dermatitis (ADASI-Score)
  • Hyperfused area skin surface
  • Psoriasis Skin Severity Index (PASI)
  • Overall Lesion Severity (OLS)
  • Irritation, sensitisation of topicals & transdermal application systems
  • Phototox/Photo allergenicity
  • Repeat open application and irriation test
  • Washing test
  • Skin Advanced Glaycation Endproducts (AGE Reader)
  • Skin Biopsies
  • Subcutaneous Adipose Tissue Biopsies
  • Muscle Biopsies
  • Subcutaneous Implantations
Endocrinology/Metabolism
  • Oral glucose tolerance test (OGT)
  • Intravenous glucose tolerance test (ivGT)
  • Glucose clamp investigations
  • Continuous glucose monitoring (CGM)
  • Insulin resistance assessment
  • Alpha and beta cell function assessment (Arginintest/glucagontest with C-Peptide and Proinsulin Quantification)
  • ACTH test
  • LH / FSH test
  • Body fat distribution (DEXA)
Gastroenterology
  • Abdominal sonography
  • Gastric emptying (SPECT, Hydrogen Breath Test)
  • Gastroscopy
  • Functional tests, e. g. Pentagastrine test
  • Liver biopsies
  • Liver Elastography (FibroScan®)
Gynaecology
  • Transvaginal ultrasound
  • Vaginal cytology
  • Endometrial biopsy
  • Insler and Hoogland Score
Ophthalmology
  • Visual acuity
  • Electrooculogra
  • Fundusphotography
  • Retinal scanner
  • Retinal Endothelial Function
  • Optical coherence tomography (Talking Eyes®)
Pharmacology

Controlled drugs

  • Trials in healthy subjects with opiods

First-into-Man (FIM)

  • Large intensive vital monitoring capabilities
  • Collaboration with Intensive Care Units in close praximity at different sites
  • Experience in FIM submission to BfArM an EC
  • Online bioanalytics (i. e. for dose escalation studies)
Renal function
  • Renal plasma flow rate
  • Glomerular filtration flow rate
  • Urinary output
  • Urinary electrolyte and cratinin excretion
  • Renal tubular function (lithium clearance)
  • Osmolality
  • Cystatin C
  • Iohexol
  • Pharmacokinetics in patients under dialysis
Respiratory
  • Spirometry (FEV, PEV, PEFT) including reversibility testing
  • Spiroergometry
  • Pulmonary function testing
  • Metacholine challenge test
  • Allergen challenge tests
  • Skin prick tests
  • Body plethysmography
  • Induced sputum, nasal provocation & lavage
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