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