PHARMBIOTEST offers a full services of bioequivalence/pharmacokinetic studies.
PHARMBIOTEST combines clinical unit with the bioanalytical laboratory. In bioequivalence/pharmacokinetic studies biological samples must be transported from clinical unit to bioanalytical laboratory under special conditions (temperature conditions (-80 ° C)). The transportation is expensive and has a high risk to damage the samples. The combination of clinical unit with the bioanalytical laboratory reduces the risk and the cost of studies.
To conduct bioequivalence/pharmacokinetic studies PHARMBIOTEST has:
- comfortable wards; shower rooms; free internet access, the library, board games;
- IMP storage;
- blood sampling;
- room for emergency treatment;
- meals are carried in accordance with the requirements of the study protocol;
- bioanalytical laboratory is equipped with modern analytical equipment.
Our specialists have experience in clinical trials. All investigators have GCP certifications.
The studies is conducted in accordance with international standards, state regulatory requirements and standard operating procedures. The local ethical committee is founded in PHARMBIOTEST. The committee works in accordance with the requirements of the Ukrainian legislation and international rules of ICH GCP.
- Study design
- Study protocol
- Subject size determination and randomization
- Case Report Forms (CRFs) design
- Informed Consent Forms writing
- Recruiting of healthy subjects
- Ethics Committee submissions
- Laboratory tests
- Bioequivalence clinical trials
- Adverse event reporting
- Clinical data processing and statistics
- Drug/metabolite assay method development and validation
- Drug/metabolite analysis in biological matrices
- Bioanalytical report writing
- Bioanalytical data processing
- pharmacokinetic parameters calculations
- Clinical/final report writing