Expertise

Pharmacokinetic trials in patients

CCDRD has extensive know-how with the regulatory requirements and specific workflows of performing pharmacokinetic trials in patients. These trials are comparable with phase III studies from the organizational point of view but require experienced teams for pharmacokinetic sampling, sample storage and logistics as well as well-established workflows with experienced bioanalytical facilities.

Services offered:

  • Feasibility evaluation in every indication
  • Strong clinical networks and investigators, especially in oncology, neurology and CNS indications, dermatology, ophthalmology
  • Experienced investigators and study teams for pharmacokinetic sampling in addition to the indication-specific investigators at sites
  • Established workflows for controlled pharmacokinetic sample shipment
  • Established workflows with pre-qualified bioanalytical providers
  • One contract for full services including bioanalysis

Bioequivalence studies in patients

Oncology

  • Capecitabine
  • Hydroxyurea
  • Goseriline
  • Estramustine
  • Chlorambucil

Central Nervous System Disorders

  • Risperidone, long-acting depot, single and multiple dose trials
  • Paliperidone, long-acting depot, single and multiple dose trials
  • Clozapine, single dose trial

Rheumatology and Psoriasis

  • Methotrexate

Respiratory Disease

  • Salbutamol Metered Dose Inhaler

Therapeutic equivalence studies

Dermatology

  • Calcipotriol/Betamethasone ointment in Psoriasis patients
  • Bethamethasone cream
  • Aciclovir cream
  • Hydrocortison
  • Sulfadiazine
  • Terbinafine
  • Triamcinolone

Renal Disease

  • Erythropoetin zeta in renal anemia patients
  • Sevelamer in dialysis patients

Diabetes

  • Insulin, recombinant formulations

Respiratory Diseases

  • Budesonide in asthma patients