Bioanalysis
We carry out bioanalysis studies for drug and/or metabolite determination in fluids (plasma, urine, etc.) and human or animal biological tissue homogenates.
Our long-standing experience in the analytical field and our deep knowledge of the regulatory environment enable us to offer a complete bioanalytical service at all the stages of drug research, development and commercialisation, participating and collaborating with our customers in: a) drug discovery phase, with fast screening of candidates in ADME preliminary studies; b) preliminary preclinical and regulatory pharmacokinetic and toxicokinetic studies in different animal species, and c) phases I through IV clinical studies, such as bioavailability, bioequivalence, interaction, etc. studies.
We can offer our wide experience in development and validation of bioanalytical methods in any biological matrix (plasma, whole blood, urine, tissues from any origin, etc.) by means of state-of-the-art bioanalytical techniques, mainly HPLC-MS/MS, for molecules with different and special chemical structure and properties, involving in many cases novel analytical designs adjusted to the product’s characteristics (e.g. endogenous substances, reduced-stability metabolites, peptides, etc.). We perform validation of methods that have been developed both in GLP and in non-GLP environments, adjusted to the purposes and uses of the method, and we carry out incurred sample reproducibility studies. We perform drug and metabolite quantification studies in preclinical and clinical trials, both in GLP and in non-GLP environments, regarding innovative as well as generic products, within the times required by our customers, at quite adjusted and competitive prices.
From a regulatory viewpoint, sample validation and analyses are carried out under FDA guidance (“Guidance for Industry: Bioanalytical Method Validation, 2001”) and under the AAPS Workshop Report (Crystal City III, 2007) recommendations. Also, in most cases, the studies are organised as multicentre trials in which the study sponsors, hospitals and other CROs participate besides Kymos, and we hold ourselves responsible for managing sample shipment and reception from external centres.
To ensure the quality of these studies we have an independent Quality Assurance Unit, highly experienced within the field of bioanalysis and with wide knowledge of the European (EMEA/OCDE) and American (FDA) GLP regulations.
