Bioanalytical Testing

We provide analytical services from pre-clinical studies through Phase III, including full statistical evaluation. Our experienced team has successfully completed more than 780 biostudies for pharmaceutical companies across Europe, the United States, Asia, and Australia.

The Bioanalytical department works closely with our Clinical department to deliver complete bioequivalence studies — covering clinical, analytical, pharmacokinetic, and statistical components — as well as diagnostic biomarker analyses.

Our team of skilled analysts and laboratory technicians operates in a modern facility equipped with HPLC/MS/MS triple quadrupole systems, which feature dual-channel HPLC configurations. This setup allows the analysis of up to 3,750 biological samples per day, including calibration and QC samples (depending on complexity). Additional technologies include HPLC/UV, HPLC/HR-MS, and LC/ICP-MS. High-throughput sample preparation is supported by an automated Hamilton robotic system.

Bioanalytical Testing

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, over 450 methods have been developed and validated.

A full list of our validated methods is available on request. If a required method is not listed, our team can develop it according to the specific needs of the project.

PK/TK studies on animals

In the pre-clinical evaluation of active ingredients, we work with partners in Europe to conduct toxicological and pharmacokinetic studies in animals.

Throughout all clinical trial phases, we cooperate with our in-house Clinical department and international clinics performing PK/PD and BA/BE studies. Our support includes:

Protocol development
Method development and validation
Preparation of sampling manuals
Sample analysis
Pharmacokinetic and statistical evaluations

Analyses of drugs and their metabolites

During clinical trials in all phases, the Bioanalytical department works with the Clinical department of Conscio and with external clinics worldwide conducting their own PK/PD and BA/BE studies.

We provide complete analytical support from protocol preparation, through method development and validation, preparation of sampling manuals for clinical sites, analysis of the investigated active ingredients and/or metabolites in collected biological samples, to pharmacokinetic and statistical evaluation of the studies.

Determination of structure of metabolites

This service is provided mainly on request and is typically performed in cooperation with our Analytical R&D department. It includes the identification and structural elucidation of metabolites, as well as their isolation from biological matrices. These projects are often carried out in collaboration with Phase I clinics.

Pharmacokinetic and statistical assessment

Calculation of pharmacokinetic parameters and statistical evaluation of study results are performed using specialised software:
Phoenix® WinNonlin® (Certara USA, Inc., Princeton, NJ, USA)
SAS® (SAS Institute Inc., Cary, NC, USA)

Services offered:

tables, listings, and figures (TLF)
calculation of pharmacokinetic parameters (non-compartmental analysis)
- single dose: AUCt, AUC∞, partial AUC, Cmax, Tmax, λz, t1/2, etc.
- steady-state: AUCτ, Cmax,ss, Cmin,ss, Cτ, Cavg, Tmax,ss, Fluctuation, etc.
statistical evaluation of bioequivalence – average bioequivalence (parallel design, 2×2 crossover design, replicate 2-treatment 4-period design, etc.) using SAS procedures GLM or MIXED
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.
testing of statistical significance of the observed influences – influence of the formulation, period, sequence, etc.
and other calculations according to the requirements of the customer

Provision of clinical and bioanalytical data in CDISC SDTM and ADaM format, including supportive documentation (Define-XML, xDRG), is available on request, subject to project-specific feasibility and regulatory requirements.