DMPK Services: Drug Metabolism & PK Profiling

Q: What is DMPK, and how is it different from ADME?

ADME is the list of assays: absorption, distribution, metabolism, excretion, each producing a number. DMPK is the discipline that reads those numbers together with in vivo exposure and turns them into a decision about a molecule: advance it, fix it, or kill it. You can buy ADME assays one at a time next door; DMPK is what you buy when the numbers need to become an argument.

Q: What is in a candidate-selection DMPK package?

The in vitro ADME panel run as one dataset, stability, permeability, CYP interaction including phenotyping, protein binding, solubility, plus bioanalysis of your in vivo PK samples, metabolite identification on the Orbitrap where routes matter, and cross-species scaling toward a human dose projection. It closes with one interpreted report in which the in vitro and in vivo results are read against each other, not three data dumps stapled together.

Q: Where does the in vivo study actually run?

At your CRO or one of our partner facilities; no animals are dosed in this building. Your study site doses and collects, the samples ship here, and the bioanalysis, TK or PK parameters and interpretation happen under one roof with the in vitro data. You keep your vivarium relationship, and your DMPK story still comes from a single accountable lab.

Q: How long does a DMPK package take?

Roughly four weeks from compound to interpreted package for the standard scope, and we commit to your date before you commit compound. Cut-down panels for hit-to-lead triage run faster; packages with metabolite identification or unusual matrices are scoped honestly rather than promised optimistically.

Q: What does metabolite identification add to the package?

Names instead of inferences. A disappearing parent tells you clearance is happening; accurate mass on the Orbitrap tells you where the molecule is being hit and what it is turning into. That is how a stalled series gets rescued, the soft spot gets named, chemistry blocks it, and it is how metabolites-in-safety-testing questions get answered before an agency raises them.

Q: Can you rescue a series that keeps failing on exposure?

That is a standing use of this package. Repeated exposure failures usually trace to a nameable cause: a metabolic soft spot, efflux, solubility masquerading as absorption, or plasma instability posing as clearance. The panel is scoped to hunt the cause rather than re-measure the symptom, and the report says what to change, not just what the numbers were.

Q: How does cross-species scaling support a first-in-human dose?

Clearance and exposure compared across species, allometric scaling run with our modeling partner, and the output framed as a defensible starting-dose argument rather than a spreadsheet. Your clinical team and your regulator both read the reasoning, so the reasoning is written to be read.

Q: Does our compound structure leave the United States?

No. This is a US laboratory; the structure and the material stay inside the country from receipt to report, which for many sponsors is now a board-level requirement rather than a preference. Chain of custody is documented from the day the compound lands.

De-Risk Your DMPK Profiling, Candidate to IND.

Brief PhDs on your compound, species and study.

Discovery DMPK Package Scoped To A Candidate Selection Decision, In Four Weeks
DMPK Studies Combining In Vitro ADME Data With In Vivo PK Sample Bioanalysis Lab
Cross-Species DMPK Analysis, Clearance Scaling And Human Dose Projection Support
DMPK Services At A US-Based Lab CRO Where The Compound Stays Inside The Country

Regulated And Inspected By:

DMPK Is The Package That Turns Separate Numbers Into A Candidate Decision

One scoping pass covers the seven CYP isoforms with time dependence, the transporter panel, and induction across AhR, CAR and PXR, so the package is complete the first time.

A Package Scoped To The Decision You Face

Candidate selection, an IND, or a series that stalled. The scope follows from that, not a list.
You are quoted for the decision, so nobody sells you assays that will not change the answer.

Metabolite Identification On The Orbitrap

Soft spots and major routes named by accurate mass, not inferred from a disappearing parent.
Discovery and regulated quantitation on the same instrument, so nothing is handed onward.

In Vitro ADME Panel Run As A Single Dataset

Stability, permeability, CYP including polymorphism, binding and solubility, shared controls.
Numbers generated in one place compare to each other, which separate vendors cannot promise.

One Interpreted Report, Not Three Data Dumps

A single report where the in vitro and in vivo results are read against each other, with a view.
Written by the scientists who generated it, so the caveats are in the report and not implied.

In Vivo PK Bioanalysis From Any Study Site

Your in vivo study runs at your CRO or one of our partners, and the samples are analyzed here.
Each group does what it is best at, with no margin lost to a lab subcontracting analysis.

About Four Weeks From Compound To Package

The full package runs to roughly four weeks, and we scope to your date before you commit to it.
Individual assays are faster, and we say so when a single number would answer your question.

Cross-Species Scaling And Dose Projection

Clearance compared across species, with human dose projection through our modeling partner.
The step that turns a table of numbers into the argument your board actually wants to hear.

Your Compound Never Leaves The United States

A US-based laboratory, so both the structure and the material stay inside the United States.
Increasingly the deciding factor for sponsors reconsidering where discovery work is placed.

The Decision Your DMPK Package Is Being Built To Support

Name the go or no-go first, and the assay list falls out of it. Each stage links to the page where that work lives.

Hit To Lead Triage

A cut-down panel across a series, to rank compounds before the chemistry commits
Read more
Lead Optimization Cycles

Repeat panels through design cycles, with numbers that compare run to run
Candidate Selection

The full package on two or three finalists, scoped to the go or no-go decision
IND-Enabling Support

DMPK data assembled to support the nonclinical package and the tox program
Read more
First In Human Dose Projection

Scaling and exposure modeling shaped into a starting-dose argument
ADC And Biologic DMPK

Payload, total antibody and conjugated species, for modalities beyond small molecule
Read more
Peptide And Macrocycle DMPK

Stability and exposure for peptides, macrocycles and other non-standard chemistry
Rescuing A Stalled Series

Metabolite identification and soft spot work when a series keeps failing on exposure
Read more

Ready To Start? Scope Your DMPK Package.

Tailored DMPK quote in 2 days.

De-Risk Your Candidate Decision With PhD Scientists For DMPK Packages, On Budget And On Time

DDI work fails on coverage gaps that a reviewer finds quickly. We scope against the guidance before the first incubation.

Talk Science First? Book a Call With Our DMPK Experts.

Discuss endpoints, species and timeline.

Protect your decision. The package is scoped backwards from the question you are answering, so you are not quoted for assays that cannot change which molecule you take forward.
Protect your dataset. In vitro and in vivo results are generated against shared controls in one laboratory, so they can be read against each other rather than reconciled across two vendors.
Protect your intellectual property. This is a US-based laboratory. Your structure and your material stay inside the country, which is now the deciding factor for a growing number of sponsors.

20+Years Of Drug Metabolism And PK Work For Biotech, Since 2003

500+Custom Methods, Including In Vitro And In Vivo DMPK Work

Control Cost, Hit Timeline

Any scope change goes through a pre-approved SOW addendum, so your cost cannot move without an SOW addendum you have already approved. A DMPK package is quoted as a package, scoped to your decision rather than assembled from a price list, and it runs to about four weeks from receipt of compound. Where the in vivo arm is involved, the study runs at your CRO or one of our partners and the samples are analyzed here, so the two timelines are planned together rather than discovered in sequence. You can opt for rolling data and act before the interpreted report lands. Your compound stays under documented chain of custody and never leaves the country.

Fast Quote, Quality Work

Tell us the decision first, not the assay list. Candidate selection between finalists, a series that keeps failing on exposure, or a nonclinical package heading toward an IND all need different scopes, and the scope is what the quote is built from. Then four things finish it: how many compounds, which species, whether an in vivo arm is included and who runs it, and your date. If a single ADME assay would answer the question more cheaply than a package, we will tell you so and point you at that page instead. Send the structures and the decision and you get a scoped quote and a timeline back, built against exactly that.

Sponsors Who Have Made This Call Before, And How It Went For Them

Quoted with permission, names withheld. Yours would be too.

Executive Director, Pharmacokinetics

We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects
Sr. Dir., Bioanalytical Development & QC

NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms
Director, PK

We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
VP, PK PD Analysis

NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
Sr. Associate Dir., Clinical Trials

We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
Head, PK

This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.

Need DMPK Method Development? Small Molecule or Biologic.

Share MW, modality and species. Keep your structure.

Why Do Biotechs Bring Us The Package Behind A Candidate Decision?

No assay is quoted that cannot change the decision, and your structure and material never leave the United States.

Expert DMPK Package Scoping Work

Scoped backwards from your decision, so no assay is quoted that cannot change it.
In vitro and in vivo results all generated on shared controls, inside one laboratory.
Senior scientists here carry 18+ years in the industry, and they stay, which is why the same people are on your study next year.

Built For Sponsors Reshoring Work

A US-based laboratory, so structure and material both stay inside the country.
Your in vivo study stays with your own CRO, and no margin is lost to a subcontractor.
A view on what the molecule is doing, written by the scientists who generated it.

Basics Of Bioanalysis | NorthEast BioLab

Drug Discovery and Development Process

Do you know about drug development life cycle? And, what is drug development process timeline?…

ADME, DMPK & Met ID Video Read More

From Your Decision to a Reviewer-Ready DDI Package, in Six Steps

Everything is scoped backward from your go or no-go, and each gate ends with a scientist's read on the data so far.

1. The Decision

We start from what you are deciding, and scope the package backwards from it.
2. Quote And SOW

One package price with the in vivo arm and its site settled before work starts.
3. Method Setup

An LC-MS method built for your compound and every matrix the package needs.
4. In Vitro Panel

Stability, permeability, CYP, binding and solubility run against shared controls.
5. In Vivo Analysis

Study samples from your site or a partner site, analyzed on the same method.
6. One Report

In vitro and in vivo read against each other, with a view, in about four weeks.

Why Do Sponsors Choose Our DMPK Lab Ahead Of An IND?

Because the package is assembled for the reviewer who will read it, with no gap that sends you back for a second round.

Get Your DMPK Plan Reviewed By PhD Scientists.

Send your plan. We'll flag pitfalls before they cost you.

Your package is scoped to the decision you face, so no assay is quoted that cannot change it.
In vitro and in vivo data come from one lab on shared controls, so they can be read together.
A US-based laboratory, so your structure and your material stay inside the country.
The whole package runs in about four weeks at one package price, itemized line by line.

Regulated And Inspected By: