We provide added value to our customers by advising on the scientific and regulatory situations that could arise in the development of these compounds. We are a one-stop facility where customers can perform Phase 1 and Phase 2 studies in the same facilities including the pharmacokinetics and pharmacodynamics assessment. This strategy provides faster results for companies for decision taking before embarking with additional cohorts in the development of the products.
FDI Bioanalytical Laboratory (FBL) is a unit of FDI Clinical Research that specialize in qualitative and quantitative analysis of chemical and biological pharmaceutical compounds.
We provide to our customers not only scientific but also clinical expertise in the development of pharmaceutical products. Our scientists have extensive experience in the development and validation of bioanalytical methods in the determination of small molecules and their metabolites. In addition, we are capable of performing sample analysis for pharmacokinetics/toxicokinetics of pre-clinical and clinical samples. FBL has the latest analytical equipment to quantify pharmaceutical compounds and metabolites with an extraordinary turn-around time. Two Ultra performance liquid chromatographs (Agilent 1290) coupled to two tandem mass spectrometers (Agilent 6460 QQQ) are available.
Assay Development and Validation
FBL has more the 15 years of experience in the development of analytical methods for the determination of small molecules, peptides, and metabolites in different human compartments including plasma, serum, urine, peripheral blood mononuclear cells, and tissue samples. We can develop customized methodologies for our clients as well as implementing validating assays (technical transfer) complying with timeline goals. Challenging assays are welcome by our scientists and we are available for consultation, design and writing of bioanalytical protocols. We are committed to provide quality results using GLP, Lean-Six Sigma and FDA regulations.
The validation of analytical methods is essential to obtain data necessary to support regulatory submissions of the pharmaceutical product. We follow the latest validation guidelines established by the industry and federal agencies, providing quality data to our customers. FBL uses the following validation parameters for research or for submission to a regulatory agency: (i) accuracy, (ii) limit of detection, (iii) limit of quantitation,(iv) linearity, (v) precision, (vi) range, (vii) robustness, (viii) ruggedness, and (ix) specificity.
The quality control team of Fundacion de Investigacion de Puerto Rico is in charge to independently monitor the performance of FBL following GLP and FDA guidelines and regulations. This team is involved in the internal auditing of studies and FBL facilities. They are in charge of administering CAPA and document control systems; reviewing equipment qualification, calibration and maintenance. The studies performed at FBL are of the highest standards complying with regulatory requirements. A sample chain of custody is in place to determine the location at all times. The Director of FBL, Dr. Jose F. Rodriguez-Orengo, was past Executive Director of the Puerto Rico Institute of Forensics Sciences and implemented a system where the Institute obtained accreditation by 5 different US regulatory agencies in 2 years.
FBL provides services to generate and report pharmacokinetics data for clinical trials that are taking place in our Phase 1/2 facilities, or elsewhere. We employ the industry-standard WinNonlin® software to perform different analysis such as: (i) non-compartmental analysis, (ii) compartmental PK analysis, (iii) Dose proportionality, (iv) bioavailability, (v) drug-drug interactions, (v) and steady state kinetics.