MicroConstants China is the first OECD-GLP compliant bioanalytical service provider in China and it has received ISO 17025 accreditation from the China National Accreditation Service for Conformity Assessment (CNAS). Our Bioanalytical Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins and peptides using LC/MS/MS, HPLC/UV, and ELISA detection. We have experience analyzing API and metabolites in diverse biological matrices and can provide bioanalytical support throughout all stages of preclinical and clinical development, including PK/TK studies, BE/BA studies, tissue distribution studies, and drug-drug/drug-food interaction studies.
We provide bioanalysis plans for every bioanalytical study and conduct protocol, in-process and reporting phase QA audits for every GLP/GCP project. Method validations and GLP/GCP sample bioanalysis are performed in accordance with applicable USFDA, CFDA and EMA regulations and guidelines.
Our PK specialist can conduct pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform either model dependent (compartmental) or model independent (noncompartmental) analyses using validated Phoenix WinNonlin software to calculate bioequivalence, drug exposure, and drug recovery data. We will also provide assessments of PK/PD relationships.
MicroConstants China shares the same SOPs, LIMS, and quality system as MicroConstants, Inc. in San Diego. Data generated from our laboratory in Beijing has been accepted by relevant regulatory authorities for IND and/or NDA approval.