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 an important step in the drug discovery process and is best done early. To help you gain critical insight into your drug’s absorption, distribution, metabolism, and excretion attributes, Pharmaron has a broad spectrum of in vitro ADMET services.

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 with a bio-relevant membrane
  • Evaluate excipient effects and compare formulations, food effects, 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, 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.