Bioanalysis
We have wide experience in developing and validating analytical methods in different biological matrices using state-of-the-art techniques (HPLC-MS/MS) to help veterinary companies perform clinical trials (e.g. bioequivalence, pharmacokinetics) and residue studies.
Veterinary development of bioanalytical is a challenge because of drug extraction in analytically complex biological matrices (fat, skin, muscle, liver, kidney, eggs, milk, faeces, bowel content, etc.) in addition to the routine ones like plasma or urine. In many cases, method development and validation entails the performance of tests that require drug administration to the animal species under trial with the purpose of obtaining incurred samples to study drug stability and retrieval. One of Kymos’ strong points is the development and validation of robust and highly sensitive bioanalytical methods, primarily by means of HPLC-MS/MS, for molecules with different structure and chemical properties which in many cases involve novel analytical designs adjusted to the characteristics of the product. Kymos develops and validates bioanalytical methods and perform incurred sample analysis both for innovative products and for generics, within the times requested by the customers at quite adjusted prices. From a regulatory viewpoint, validations are carried out according by the requirements of the regulations in force such as "Notice to Applicants and Guideline" Vol. 8, 2005 ("Establishment of maximum residue limits (MRL) for residues of veterinary medicinal products in foodstuffs of animal origin"), and "Guidance for Industry: Bioanalytical method validation", FDA, 2001. Also, in most cases, the trials are organised as multicentre studies with the intervention of the study sponsors and the animal-managing CRO in addition to Kymos. Kymos cooperates consistently with this type of CROs to be able to offer complete pharmacokinetic, bioequivalence, residue, dose confirmation, etc. studies.
