Regulatory DMPK

Regulatory DMPK Services

Pharmaron provides comprehensive IND/NDA filing DMPK studies that meet FDA, OECD and NMPA regulatory requirements. In addition to the IND/NDA regulatory filing 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.

Regulatory in vitro ADME Studies

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

Regulatory in vivo PK Studies

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