Bioanalysis of Small Molecules & Generics

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 a 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:

• Preclinical studies
     • PK (pharmacokinetics) and PD (pharmacodynamic) calculations and statistics
     • Metabolite identification and quantitation
     • Toxicokinetics
     • Biomarkers/Pharmacodynamics
• Clinical studies
     • Phase I-IV pharmacokinetics including first-in-man dose escalation studies
     • Drug-drug interaction studies
     • Biomarkers/Pharmacodynamics
     • Bioequivalence studies
• Percutaneous absorption
• Residue depletion studies
• Absorption studies

Bioanalysis Laboratorium
Analytisches CRO LC-MS/MS API 6500

PRECLINICAL , cLINICAL AND BIOEQUIVALENCE Studies

Our bioanalysis experts are experienced in the comprehensive management of preclinical and clinical bioanalytical studies from phases I to IV as well as bioequivalences; offering end-to-end service from IMPD review to final reporting. We work in alliance with reputed European preclinical and clinical centers following EMA/FDA guidelines and operating with most animal models including rats, mice, rabbits, minipigs, cats, dogs, non-human primates, swine, cattle, sheep, poultry and horses. High-quality standards, narrow timelines and competitive prices are key elements for our delivery.

Our experts can transfer existing bioanalytical methods and have a long list of validated methods offering the clients the opportunity of directly analyzing 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. We are fully coordinated with our alliance partners to provide One Stop Shop services in the following areas:

WE OFFER AN EXTENSIVE LIST OF VALIDATED METHODS

CLINICAL STUDY MANAGEMENTSTUDY REPORTING
  • Protocol writing
  • Submission to Ethics Committee and Regulators
  • Insurance contracting
  • Clinical center management and monitoring
  • Study execution
  • 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, ECLA 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
  • Physical-Chemical analysis of administration solutions/formulations

PK and PD calculations and statistics

We have decades of experience providing pharmacokinetic, pharmacodynamic, toxicokinetic calculations and statistics with Phoenix WinNonlin® 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, self-generated ones and special considerations
  • Bioequivalence (AUC, Tmax, Cmax)
  • Evaluation of preclinical and clinical studies in human and animal health and consulting for designing new studies

PK/PD analysis is conducted using the gold standard Phoenix WinNonlin® software 8.2 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
Pharmakokinetic Evaluation

We also offer the following additional bioanalytical services:

PERCUTANEOUS ABSORPTION

In vitro percutaneous absorption studies to test how topical drugs absorb and break down through the surface of the skin and synthetic membranes. Learn more about this service here.

RESIDUE DEPLETION STUDIES

Comprehensive study management with strategic partners for preclinical experimentation and animal housing. Veterinary drug validation with cats, dogs, swine, cattle, sheep, rabbit, poultry and horses as well as complex matrices such as liver, fat, muscle, brain, milk, honey or eggs. LIST OF VALIDATED BIOANALYTICAL METHODS

ABSORPTION STUDIES

Absorption studies of dietary supplements and phytopharmaceuticals: We conduct bioanalysis on active ingredients in biological samples coming from clinical studies on nutraceuticals, medical devices or phytopharmaceuticals, measuring effects and absorption rates in the living organism.

The development of these methods is often very challenging, since most of the times a complex mixture of different natural actives are present. We have wide experience in the development of complex methods with challenges regarding recovery from different matrices, low LOQ, multiple analytes, etc.

Percutaneous Absorption
Laboratory analytist with test tubes

Why choose KYMOS to support your bioanalysis of small molecules requirements

We are 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/MSUPLC-HRMSICP-MS
Sciex API 6500+, API5500, API4000, API3200 and Agilent 6490QTof Xevo G2SAgilent 7700 and 7800

DO YOU NEED MORE INFORMATION OR A QUOTE?

Related Services

Pharmacokinetics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Bioequivalence Studies

Bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase centre.

Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

Get in touch


    EU Sites

    Kymos Group

    Barcelona
    Spain

    Prolytic

    Frankfurt
    Germany

    Pharmaprogress

    Ancona
    Italy

    EU Offices

    Paris
    France

    Basel
    Switzerland

    Milano
    Italy