Clinical Pharmacology

Offered services

Full study projects (from strategic planning and protocol writing to final study report) under GCP and GLP conditions

Individual services on:

• Study design
• Protocol writing
• Clinical analytics in collaboration with our partners
• CRF design
• Study conduct according to GCP
  
  

Drug bioanalytics (HPLC, GC, LC-MS/MS, different assays) under GLP conditions with various contract GLP – labs to ensure priority status and state-of-the-art technology


Biometry including database design, data entry, quality checks, generation of tables, graphs and statistical analysis according to ICH criteria

• Pharmacokinetic evaluation and interpretation
• Final study report
• Scientific interpretation of results
• Investigational drug import to Switzerland
• Study drug packing
  
  

Studies

• Single and multiple rising dose first-into-man studies
  
• Pharmacokinetic profiling studies
  
• ADME studies with radio-labelled compounds
  
• Absolute bioavailability studies
  
• Food interaction studies
  
• Drug-drug interaction studies
  
• Bioequivalence studies
  
• Pharmacodynamic bioequivalence studies
  
• Pharmacokinetic / Pharmacodynamic studies
  
• With our hospital partners, we are able to conduct the studies in addition to healthy subjects in special patient populations
  
  

Special in-house knowledge of the following therapeutic areas and development research activities:

• CNS (Neurology: Alzheimer disease, general spasms, epilepsy, head trauma, stroke, migraine, multiple sclreosis, amyolateral sclerosis; Psychiatry: depression, schizophrenia, pain, bipolar disorder, aggression, social phobia)
  
• Cardiovascular (Indications: hypertension, congestive heart failure)
  
• Rheumatology (Indications: osteoid and rheumatoid arthritis)
  
• Anti - platelet drugs (Indications: PTCA, acute coronary syndrome, stroke)
  
• Respiratory (Asthma, inhalative devices)
  
• Oncology (Biological response modifiers, supportive therapy to chemotherapy)
  
• Immunology (Transplantation, allergy, atopical dermatitis)
  
• Anti-glaucoma drugs
  
• Topical formulations (Including nasal sprays, eye-drops, transdermal application systems)
  
• Genitourinary
  
• Medical devices
  
• Life-cycle developments (e.g. slow release, i.v. and nasal formulations)
  
• Gene technology products (e.g. Cytokines, vaccines)
  
• Additional expertise available in our specialist network
  
  

Please contact:

Michael Seiberling, M.D.
Head of Clinical Pharmacology
Lettenweg 118
CH-4123 Allschwil , Switzerland
Tel.: +41 / 61 / 487 24 00
Fax: +41 / 61 / 487 24 01
e-mail: mseiberling@pharmacontract.ch