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Service Title

Service Description

Pharmaceutical Testing

Research and development, analysis and testing, quality control and more.

Bioanalytical Testing

Analytical service for clinical and pre-clinical studies including statistical evaluation.

Overview

Most activities of the Bioanalytical department, which collaborates with the Clinical department of the company, are focused on conducting complete bioequivalence studies (including clinical, analytical, pharmacokinetic and statistical part)). Since being founded, Quinta has completed more than 600
bio-studies for pharmaceutical companies, particularly in Europe, the United States, India and Australia.

The Bioanalytical department comprises a team of experienced analysts and laboratory technicians. The laboratories are equipped with nine modern LC/MS/MS devices with triple quadrupoles, six of which being additionally equipped with a 2-channel HPLC system. The capacity of the Bioanalytical department is up to 3 750 analyses of biological samples per day (including calibration and QC samples and depending on the complexity of the analyses).

A new area of the Bioanalytical department is the analyses of diagnostic biomarkers.

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Development and validation of bioanalytical methods

Bioanalytical methods are developed and validated in accordance with GLP rules and ICH/FDA and EMEA guidelines. So far, more than 250 methods have been developed and validated in the company. Their overview can be seen in the List of validated bioanalytical methods.

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BE studies on animals

In the area of ​​pre-clinical evaluation of active ingredients in animals, the Bioanalytical department cooperates with partners in the Czech Republic as well as in the world and conducts its own toxicological and pharmacokinetic studies. During these activities, Quinta provides complete analytical support comprising inspections of the quality of the application forms, analyses of the studied active ingredients and metabolites in the collected biological samples. Quinta also performs the subsequent toxicokinetic and pharmacokinetic evaluations.

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Analyses of drugs and their metabolites

Within clinical trials in different phases, the Bioanalytical department cooperates with the Clinical department of Quinta as well as with external clinics in the world that conduct their own PK/PD and BA/BE studies. The Bioanalytical department provides a complete analytical support from the preparation of protocols, through the development and validation of bioanalytical methods, preparation of the sampling manuals for clinical workplaces, analyses of the studied active ingredients and/or metabolites in the collected biological samples to the pharmacokinetic and statistical evaluation of the studies.

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Determination of structure of metabolites


In addition to its own Clinical department in the company, the Bioanalytical department cooperates with many clinics involved in Phase I clinical trials. Highly trained and experienced employees also take part in determining the structure of metabolites and their isolation from biological matrices.

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Biostatistic evaluation

We perform calculations of pharmacokinetic parameters and statistical evaluation of the results of studies results using specialized software:

  • SAS® (SAS Institute Inc.,www.sas.com)
  • WinNonlin®Professional (Pharsight Corporation, www.pharsight.com)

Services offered:

  • displaying graphs of pharmacokinetic profiles (mean, individual, overlay of all the subjects for the given type of treatment, etc.)
  • calculation of pharmacokinetic parameters (non-compartmental model)
    • single dose: AUC0-t     AUC0-∞     Cmax  Tmax      λz   T1/2
    • steady-state: AUCτ   Cmax,ss         Cmin,ss         Tmax,ss         Fluctuation
  • statistical evaluation of bioequivalence - average bioequivalence (parallel design, 2x2 crossover design, replicative 2-treatment 4-period design, etc.)
  • multi-dimensional ANOVA – mixed model (log-transformed data, un-transformed data), LS-means, residual variability, within subject variability, etc.
  • hypothesis testing (Schuirmann)
  • power of tests (power of ANOVA - multiplicative model)
  • non-parametric tests (non-parametric ANOVA)
  • calculation of other pharmacokinetic parameters according to the requirements of the customer, e.g. Langmuir model (in-vitro bioequivalence),
  • calculation of bioavailability (absolute, relative bioavailability)
  • pharmacokinetic / toxicokinetic evaluation (accumulation, dose-proportionality, etc.)
  • descriptive statistics, confidence interval, outlying value ​​tests
  • statistical significance of the observed influences - influence of the dosage form, diet, sex, age, etc.
  • compartmental modeling (WinNonlin)
  • and other calculations according to the requirements of the customer

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API Sourcing

We offer

Other Services

and consultions

  • GMP Packaging / Labelling for stability studies and clinical testing
  • Module 3 audit
  • IMPD Compilation
  • Monitoring of studies

If you don't see what you need or have a question, get in touch with us!

  • Pharmacovigilance
  • Regulatory affairs
  • Registrations of generics in Russia
  • And more!

Don't see what you need, or have a question?
Our commercial team is happy to help!

Jiří Raška

Chief Commercial Officer

David Dvořák

Business Manager
& Scientific Advisor

Pavel Pihera

Business Manager
& API Sourcing Manager
Contact Us
clients

Testimonials

Our client loves us because of our quality work

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager