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

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 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

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: