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.

View our on-demand webinars within our DMPK series, covering a spectrum of interesting DMPK topics.

Explore Pharmaron’s DMPK Webinar Series Library

Capabilities

Regulatory in vitro ADMET Studies

Regulatory in vivo PK Studies

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

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