Regulatory DMPK

Pharmaron provides comprehensive IND filing DMPK package studies that meet FDA, OECD and NMPA regulatory requirements. All filing package studies follow GLP-like standards. Pharmaron has passed every NMPA on-site audit.

in vitro ADME Filing Package Studies

• Regulatory PPB and blood partition
• Metabolism and metabolite identification
• Permeability and transportation
• Drug-drug interactions

in vivo PK Filing Package Studies

• Single and repeated-dosing PK studies on rodent and non-rodent test systems
• Mass balance and tissue distribution
• in vivo metabolite identification/analysis
• Bridging PK studies

In addition to the IND filing package services, Pharmaron provides GLP/GCP-compliant analytical and bioanalytical services to support preclinical to clinical, from small molecule drugs to biologics, vaccines, from API pharmacokinetics to PD biomarkers and from mass balance studies on rodents by QWBA to an absolute bioavailability study by micro-dosing in human using LC/MS/MS, LBA, LSC and AMS.