Regulatory in vitro ADMET Studies

A multi-channel pipette dispenses pink liquid into multiple wells of a plate during an in vitro ADME assay for regulatory testing.

Regulatory in vitro ADMET Studies

Characterizing a drug candidate’s ADME properties and potential drug interactions is essential in drug discovery and is best done early. Pharmaron offers a broad spectrum of in vitro ADMET services to help you gain critical insight into your drug’s absorption, distribution, metabolism, and excretion attributes.

Close-up of an automated liquid handling system used in regulatory DMPK studies, featuring precision tubing and analytical components for sample preparation.

Filing in vitro ADMET Studies

  • Regulatory PPB and blood partition
  • Metabolism and metabolite identification
  • Permeability and transportation
  • Drug-drug interactions
A robotic arm holds a 96-well plate used for drug metabolism and pharmacokinetics (DMPK) studies in a laboratory setting focused on automated analysis.

Drug Absorption and Transport

  • Permeability evaluation (PAMPA, Caco-2, MDCK, and transfected MDCK cell lines)
  • Transporter investigation on substrate and inhibitor evaluation (P-gp, BCRP, BSEP, MRP2, MRP3, MRP4, OATP1B1, OATP1B3, OTAP2B1, OAT1, OAT3, OCT1, OCT2, MATE1, MATE2K, PEPT1, NTCP)
  • Hepatic uptake using media-loss method
Close-up of an IDAS1 in vitro dissolution and absorption apparatus with a pipette dispensing blue liquid into a clear chamber for testing.

in vitro Dissolution Absorption System (IDAS)

  • Combine traditional dissolution testing with a means to determine and quantify a bio-relevant membrane.
  • Evaluate excipient effects and compare formulations, food effects, and locally acting GI products.
Biopharmaceutics Classification System (BCS) chart categorizing drugs by solubility and permeability, used in regulatory DMPK evaluations.

BCS-based Biowaiver Studies

  • Regulatory acceptance of in vitro BCS classification data as a reliable surrogate for in vivo BE studies
  • Accelerated and de-risked alternative to clinical PK, BA/BE, and DDI studies
  • Applicable to high-variability drugs, drugs with serious adverse event profiles, and drugs requiring special patient populations
  • Eligibility extended to include Class I and Class III drug substances
Organized racks of pipette tips in various colors, representing tools used in discovery in vitro ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) studies.

Enzyme Drug-Drug Interactions (DDI)

  • CYP phenotyping: 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A
  • CYP inhibition: 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A
  • CYP induction: 1A2, 2B6, 3A4, 2C (if positive for 3A4)
  • Non-CYP DDI:
    • Phase I (CYP2A6, 2J2, 4F2, 2E1, AO, CES, MAO, FMO, XO, ADH/ALDH)
    • Phase II (UGTs, SULTs)

Transporter Drug-Drug Interactions (DDI)

  • Phenotyping: efflux transporters: P-gp, BCRP; hepatic transporters: OATP1B1, OATP1B3; renal transporters: OAT1, OAT3, OCT2, MATE1 & MATE2K 
  • Inhibition

Explore Pharmaron’s DMPK webinar and podcast series library

A logo for Pharmaron with text "DMPK Webinar Series" in a red box and "DMPK Insights" below it next to a microphone icon, all set against a light blue and white wavy background. Chinese characters are displayed above "Pharmaron," highlighting topics like absolute bioavailability.