BE study / Phase I study

Quinta has many years of experience in pharmacokinetic/bioequivalence studies. A team of experienced professionals will provide a complete study on healthy volunteers, on a special population group of these volunteers, or on a population with special health conditions. The activities include:

• Clinical area:
  • consultancy during the design of the study
  • compilation of the study protocol
  • designing the size of the group and randomization
  • design and development of case report forms (CRF)
  • preparation of informed consent
  • preparation and administration of documentation for the independent Ethics committee
  • preparation and administration of documentation for regulatory authorities (State Institute for Drug Control)
  • recruitment of study subjects or special populations according to the requirements of the customer
  • entry and release examinations including all the necessary laboratory clinical tests
  • conducting the study including blood sampling and clinical examinations
  • evaluation and reporting of adverse events
  • processing of clinical data and statistics

• Bioanalytical area:
  • development and validation of methods used for the determination of drugs and metabolites
  • analysis of drugs in biological matrices

• Evaluation
  • processing of bioanalytical and pharmacokinetic evaluations
  • biostatistics (using the SAS program)
  • compilation of the study report
  • archiving of the documentation

• QA / QC
  • monitoring and controlling of quality on all the stages of the study

Types of studies

Based on the requirements of the contracting authority, we conduct studies of various designs including statistical evaluation, for example:

• Pharmacokinetic studies
• Toxicokinetic studies (animals)
• Pharmacodynamic studies including the evaluation of clinical parameters
• Bioavailability
• Bioequivalence studies
• Batch linearity
• Different modes of administration / different dosage forms
• Steady-state studies
• In vitro in vivo correlation
• Interactions of drugs, food or alcohol
• Influence of diet (before/after eating)
• Effect of age / gender
• Study on a special population
• Ethno-bridging studies
• Studies on a population with special health conditions

Special populations of subjects

Quinta-Analytica keeps a large pool of active healthy volunteers and on the request of the customer will also provide a special population of volunteers or a population of subjects with special health conditions. To be able to provide a well-defined group of subjects for the Phase I and II, we work closely with social and healthcare facilities. These subjects are used for bioequivalence/pharmacokinetic studies or Phase I and II studies. We will cooperate to provide toxicokinetic or other pharmacokinetic studies on animals. These target groups are:

• preclinical part – co-operative animal studies (toxicokinetics, pharmacokinetics)
• healthy men and women
• special popuplation:
  • old men and women (> 65 years)
  • postmenopausal women
  • overweight / obese subjects
  • subjects of Asian descent
  • fast / slow metabolisers
• populations with special health conditions:
  • subjects with renal impairment
  • subjects with hepatic impairment

Design studies

We provide studies with different designs according to the requirements of the customer including consultations. These include for example the following studies:

• Single or multi-periodic studies
• Parallel, serial or crossover design
• Open (non-blinded) studies
• Blinded or double-blinded studies
• Outpatient or inpatient
• Pilot studies

QA & QC

Each study is conducted in accordance with the standards of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). The Quality assurance and quality control unit (QAU) proceed according to internal regulations and monitors the compliance of each step from planning (study protocol), through the submission to the Ethics Committee and the State Institute for Drug Control, conducting the study and its documenting, to the compilation of the final report. All activities are conducted according to Standard operating procedures (SOPs) and the Study protocol.

The data recorded during the study, data transfers and the reports are submitted to 100% control by the Quality assurance unit before the final audit of the study.

The QAU staff will organize monitoring of the studies if they take place outside the premises of our clinical facility (Phase II to IV studies) and if the sponsor delegated this activity to our CRO. Monitoring of the studies is carried out in accordance with the legal regulations, the requirements of the customer and according to our SOP.

At the request of the other party, the QAU staff can conduct an independent GCP audit. The audit is carried out according to legal requirements and according to our SOPs.