Bioanalysis of Small Molecules

KYMOS specialises in world-class bioanalysis of small molecules from fast in vivo and in vitro ADMET screenings to preclinical toxicokinetic, bioavailability and pharmacokinetic studies, drug-drug interaction studies as well as clinical trials including first in man and dose escalation studies. We are an FDA and EMA inspected, GLP-certified and GCP compliant multinational CRO with broad experience working with large generic companies in need of full bioequivalence studies, and small biotech innovators carrying out basic R&D. We also work with animal health firms to carry out residue depletion studies.Our experienced team can support you in these specialist areas:

⦁    Bioequivalence studies 
⦁    PK (pharmacokinetics) and PD (pharmacodynamic) calculations and statistics 
⦁    Residue depletion, absorption studies and percutaneous absorption

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Bioequivalence studies

Our bioanalysis experts are experienced in the comprehensive management of bioequivalence studies (from clinical phases I to IV), offering end-to-end service from IMPD review to final reporting. We work in alliance with reputed European clinical centers following EMA and FDA guidelines. High-quality standards, narrow timelines and competitive prices are key elements for our delivery:

CLINICAL STUDY MANAGEMENT

STUDY REPORTING

  • Protocol writing
  • Submission to Ethics Committee and Regulators
  • Insurance contracting
  • Clinical center management and monitoring
  • Study execution
  • Plasma sample shipment and storage
  • Phoenix WinNonlin® data analysis
  • Pharmacokinetic report
  • Final clinical report
  • Specific reports to Authorities requests

BIOANALYSIS

SUPPORT ACTIVITIES

  • LC-MS/MS and HRMS for small molecules
  • ICP-MS for metal/organometallic analysis
  • ELISA, ECL and RIA for small peptides
  • IMPD writing or review
  • Analytical testing for stability studies
  • Comparative dissolution profiles
  • Importation of reference and test products
  • Batch testing and batch release

Our experts can transfer existing bioanalytical methods and have a long list of validated methods offering the Clients the opportunity of directly analysing their samples thereby saving time and money. If one is not available, we can develop and validate the method free of charge in a timely manner. DOWNLOAD A LIST OF VALIDATED METHODS FOR BIOEQUIVALENCE STUDIES.

PK and PD calculations and statistics

We have decades of experience providing pharmacokinetic calculations and statistics for bioanalytical data coming from preclinical and clinical studies. These services are offered individually or as a packaged clinical study and include:

  • Non-compartmental analysis (NCA)
  • Compartmental modelling using built-in models or self-generated ones
  • Bioequivalence (AUC, Tmax, Cmax)

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PK/PD analysis is conducted using the gold standard Phoenix WinNonlin® software to:

  • Analyze multiple matrices (plasma, serum, urine, blood etc..), dosing schedules and dosing routes using NCA
  • Perform compartmental modelling using built-in models or self-generated ones
  • Evaluate the bioequivalence of averages, individuals, or populations

Residue depletion, absorption studies and percutaneous absorption

We also offer the following additional bioanalytical services:

Why choose KYMOS to support your bioanalysis of small molecules requirements

We FDA and EMA inspected, GLP-certified and GCP compliant and the preferred partner to several worldwide companies. Our well-established team has extensive experience developing proprietary methods from project kick-off to taking products to market and dealing with challenging projects with unstable compounds, various metabolites, endogenous compounds, strong matrix effect and extremely low LOQs. 

KYMOS has a large pool of equipment in terms of number of instruments and variety of instrumental techniques available to face projects with a high number of samples involved:

UHPLC- and HPLC-MS/MS

UPLC-HRMS

ICP-MS

Sciex API 6500+, API5500, API4000, API3200 and Agilent 6490

QTof Xevo G2S

Agilent 7700 and 780

 

Discover Bioanalysis of small molecules

To find out how KYMOS can help save you time and resources by working in partnership on bioanalysis of small molecules, contact us by filling in the form below. 
 

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