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.

Capabilities

Regulatory in vitro ADMET Studies

Regulatory in vivo PK Studies

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

Download our Drug Transporter service overview

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.

Download our IDAS flyer

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

Download our BCS-based Biowaiver eBook

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)

Watch our webinar: An Introduction to Drug-Drug Interaction