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ICBR
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bio-analysis Service

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+ 1 (38) 776-068

Centrifuge

Centrifuge

Technology
xevo XS

xevo XS

about service

  • Laboratory team at Zi Diligence appreciates the importance of delivering quality and innovative solutions to support the drug development
    programs of our clients.
  • Whether it’s combining the analysis of multiple compounds into a single assay (e.g. amlodipine/ Olmesartan/hydrochlorothiazide) or utilizing a double extraction method to analyze drug products, we find solutions to expedite the turn-around times for analysis with quality and robust assays. This all starts with developing a sound, rugged analytical methods that can be reproduced and repeated with consistent and accurate results time and time again.
  • Zi Diligence utilizes state-of-the-art LC/MS/MS platforms to meet this need of challenging analysis (lower concentration of drugs in biological samples). The scope of bioanalytical services offered include:
  • Method feasibility
  • Method development and validation
  • Method transfers
  • Bioanalysis of biological samples from BE/BA studies and clinical PK studies indifferent matrices (plasma, serum, whole blood)

Method development & validation

laboratory process prove that the methods used to reliably measure drugs and metabolites concentration in biological fluids like blood or plasma according to ICH M10

Sample analysis using LC-MS/MS (7 systems)

sample preparation to extract target analytes from complex biological matrix like blood,plasma or urine using fully validated bioanalytical method with blind sequence

600+ validated methods

we have ahuge data base of fully validated bioanalytical method for more than 600 ApI

Equipment: API by waters brand

We have in ICBR fully automated very sensitive instruments from Waters brand as xevo TQ Absolute XR Triple Quad,Xevo XS ,tqs micro

Compliance with ICH M10 guidelines

All phases of bioanalysis as development,validation,batch analysis performed according to updated guidlines as ICHM10 in2022

Specialized biologics & biosimilars clinical analysis

immunogenicity, PK/PD, comparability
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