Bioanalytics Flyer
Fast method development or implementation
carried out according to client’s instructions for all relevant
matrices, like plasma, urine, other bio-fluids and tissues from
various animal species and from humans.
Method validation according to current FDA
guidelines with a standard protocol: selectivity, recovery, matrix
effects, system carryover, linearity, lower and upper limit of
quantification (LLOQ and ULOQ), accuracy (intra- and inter-day),
precision (intra- and interday), sample dilution integrity,
short-term and long-term stability in matrix, stability in
processed sample and in solvent.
Quantitative analysis of more than 100 new
chemical entities (NCE) or registered drugs have been analysed in
non-regulatory PK screening, in in-vitro metabolic profiling, in
pre-clinical drug development packages, and in all types of
clinical trials. Present annual total throughput is more than
100,000 samples which are fully compliant with FDA and OECD
guidelines. All data are completely double-checked.
Pharmacokinetic evaluation using
WinNonlin® latest version software performed by
scientists with broad experience in metabolism and
pharmacokinetics.
N.B. Certificates of Analysis for reference
standards (GLP or GMP) can be provided, if not supplied by the
client. Harlan Laboratories is equipped with state-of-the-art
bioanalytical techniques and equipment:
- LC/MS/MS: SCIEX API 5000, API 4000, API 3000, API 365,
ThermoFinnigan TSQ Quantum, TSQ 7000; all equipped with HTC-PAL
autosamplers for high throughput analysis
- HPLC: with UV or fluorescence or other detection
- GC/MS: with EI, GC/MSn: with either EI or CI
- Automated sample clean-up: TECAN robot system
- Automated online sample preparation: using restricted access
material (RAM) and other column-switching techniques
- Off-line sample preparation in 96-well format: solid phase
extraction (SPE), liquid-liquid extraction (LLE), solid-supported
liquid extraction (SLE), protein precipitation technique (PPT)