Bioavailability & Bioequivalence
Althian, conducts studies of Bioavailablity and Bioequivalence in collaboration with a strategic local partner laboratory designated by the Mexican regulator, COFEPRIS (Comisión Federal para la Protección de Riesgos Sanitarios), as an authorized third party to conduct studies of bioequivalence and interchangeability of generic drugs in Mexico. Utilizing our Project Management Team as a single point of contact, our sponsors are assured of continual, updated reporting on all phases of these studies. All our studies are SOP-driven and developed in accordance with best practices to afford the highest quality of treatment and safety for our pool of patient volunteers.
As such, our strategic partner addresses all types of bioavailability (BA)/ bioequivalence (BE) studies in our patient volunteers in conformity to Good the Clinical Practice (GCP) guidelines drafted by the International Conference on Harmonization (ICH). They provide a 40-bed facility with the possibility of expansion due to sponsor needs. Althian’s large database of volunteers based on its in-house data, its associations with a large professional network and their association with members of the Alliance insures a timely and responsive way to handle this important component of clinical research.
Sponsors and CROs can be assured that our strategic partner has the in-house Quality Assurance staffing, knowledgeable and well-trained pharmacists and formulation scientists to handle the compounding required by the often demanding challenges of new, experimental research protocols.