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

Registration of generics in Russia

We combine 20 years of experience in Europe with the understanding of Russian needs. In addition to Czech and English, our team can also communicate in Russian, which, together with the comprehensive understanding of the European, US and Russian regulatory requirements in combination with our extensive experience, makes our services very competitive, especially in GxP, analysis, and bioavailability/bioequivalence).

Since 2010, Quinta has conducted or participated in more than 25 bioequivalence studies in Russia. We have a joint venture with the registered office in Russia, which owns clinical BA/BE facility with 44 beds and in addition to our Prague laboratory, we also have a joint bio-analytical laboratory in Russia. Our Russian joint venture operates according to our own European working procedures adapted to the current Russian legal regulations. We continuously inspect and improve the performance of our Russian partners. We also cooperate with Russian partner workplaces in pre‑clinical studies (required now by Russian law). We have a general understanding of the Russian regulatory strategy in area of generics.

Quinta offers comprehensive services to companies focusing on the Russian generic market. Whether you seek assistance with regulatory submissions in Russia, want to conduct pre-clinical generic studies or require complete clinical and bioanalytical services (bioavailability/bioequivalence (BA/BE)), our R&D, regulatory and medical team can provide you with all the support you need.

We offer the following services in Russia (all the services are available in English and Russian):

• Developmental hypothesis and evaluation of BA / BE milestones
• Type of study (for example 2 ways, fully replicated, two-stage, etc.) in accordance with the current Russian guidelines
• Calculation of the sample size, estimation of variability, optimization of blood sampling, studied population
• Selection of the clinical location for the BA/BE study in Russia
• Support for development (estimation of treatment differences using in vitro data)
• Own internal pharmacokinetics and statistical investigation (more than 350 data files, molecules). Cost-effective solutions (tenders and CRO qualifications), complete management of the BA/BE study
• Cost-effective solutions (CROs and CROs), complete management of the BA / BE study
• Import of drugs, export of plasma samples
• Approval by the Russian ethics commission
• Full clinical management, monitoring, quality Full clinical management, monitoring, quality assurance
• Bioanalytics and statistics
• Medical documentation also in Russian
• Compilation of the final report in Russian
• Quality assurance, GMP, GCP, GLP

In September 2010, the new Federal Law No. 61 "On Drug Circulation" came into effect in the Russian Federation. This law introduced a number of changes in the drug registration system. One of the most significant changes is the general requirement to conduct bioavailability/bioequivalence studies in Russia for all newly registered medicinal products for oral administration. This requirement has led to significant changes in the field of clinical trials in Russia: Since 2010, the requirement for the bioequivalence study to be conducted in Russia applies also to foreign companies regardless of whether they have already conducted these studies with the same medicinal product in other countries.

Even if the reference medicinal product is globally registered in the EU, US or other countries and its first bioequivalence study was conducted in the EU, Canada, USA, etc. with the same global original medicinal product as reference, the study should also be conducted in the Russian federation.

QA & QC

Each study is conducted in accordance with the standards of Good Clinical Practice (GPC) 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.