Preclinical DMPK · Bioanalysis · PK Studies

Integrated Preclinical DMPK & Bioanalytical CRO Services

One-stop DMPK, early safety and efficacy support to advance your pipeline — from study design through early-stage screening to IND-ready report, with transparent pricing and a standard turnaround of under 5 business days.

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GxP-aligned methods FDA / NMPA ready data US-China dual filing
Advanced LC-MS/MS instrumentation at Strivita Pharma
SCIEX QTRAP 5500 / 6500+ · Q-TOF bioanalytical platform
In vivo PK study facility at Strivita Pharma
Dedicated in vivo PK / TK facility — mouse, rat, beagle, minipig & NHP
Preclinical DMPK laboratory at Strivita Pharma
In vitro ADME & bioanalysis under one roof
NHP PK Studies
300+
cynomolgus monkey programs
Turnaround
< 5 days
standard report delivery
0+
NHP PK / TK studies delivered
0+
Early-stage compounds screened
0+
IND-enabling PK & bioanalytical studies
0+
Years of DMPK & bioanalysis experience
What we do

Three service pillars, one integrated chain

Every study anchored on our mass-spectrometry bioanalysis platform for one-stop, reliable delivery.

In vivo PK study in NHP — Strivita Pharma
300+ NHP PKdedicated monkey facility
01 · DMPK Core Services

In Vivo PK / TK & In Vitro ADME

Single- and repeat-dose pharmacokinetics in rodents and non-human primates with full PK parameterization — plus a complete in vitro ADME suite that answers key questions before you dose.

  • Rodent & NHP PK / TK · crossover BE · dose escalation · in vivo DDI · tissue distribution & excretion
  • Metabolic stability · CYP450 inhibition / induction · reaction phenotyping · metabolite ID
  • Transporter & permeability (P-gp / MRP2 / BCRP) · PPB · solubility · LogD / pKa
View DMPK services
LC-MS/MS bioanalysis laboratory — Strivita Pharma
SCIEX QTRAP 5500LC-MS/MS platform
02 · Bioanalytical Platform

Mass-Spec Bioanalysis That Makes the Hard Routine

Quantitative LC-MS/MS for small molecules, peptides and metabolites, plus high-resolution mass spec and ligand-binding assays for biotherapeutics. Fit-for-purpose method development aligned with GxP expectations.

  • Small molecule / peptide / metabolite LC-MS/MS across plasma, serum, tissue & CSF
  • Large-molecule MS: intact / reduced MW · subunit · ADC DAR · mAb quantification
  • Tiered service: T1 screening · T2 PK · T3 IND · T4 GLP — sub-pg/mL sensitivity for challenging analytes
View bioanalysis
Tox preliminary and efficacy models — Strivita Pharma
Safety + Efficacytox preliminary & disease models
03 · Beyond DMPK

Early Safety & Efficacy Evaluation

From early safety assessment to efficacy models, one integrated partner shortens your decision cycle.

  • Tox preliminary: acute toxicity · dose-range finding · tolerability & MTD exploration
  • Efficacy models: hyperuricemia · hyperlipidemia · hypertension & routine screening
  • IACUC-approved protocols · clinical observation · biochemistry · necropsy
View safety & efficacy
What we stand for

Our values, reflected in every study

Precision instrumentation, dedicated facilities and research integrity — the cornerstones of reliable preclinical data.

Precision mass-spectrometry instruments

Precision Instruments

SCIEX QTRAP 5500, 6500+ and Q-TOF mass spectrometers deliver the sensitivity and selectivity your program demands.

Dedicated animal facility

Dedicated Animal Facility

IACUC-approved in vivo facility for rodents and large animals, with strict welfare and environmental controls.

Bioanalytical laboratory workspace

Bioanalytical Workspace

Purpose-built LC-MS/MS laboratory with validated workflows, sample-tracking and audit-ready documentation.

Research integrity and data quality

Research Integrity

ALCOA+ data integrity, QA oversight and transparent reporting — every data point attributable and reproducible.

Why Strivita

Quality you can trust with confidence

Every data point attributable, reproducible and traceable — from raw data to final report.

GxP-aligned Quality

Validated methods, controlled documentation and QA oversight at every step — aligned with NMPA / FDA expectations.

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Data Integrity

Audit trails, raw-data retention and transparent, traceable reporting built on ALCOA+ principles.

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One-Stop Ownership

Study design, in-life, bioanalysis and reporting under one accountable team — a single point of contact.

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Transparent Pricing

Instant online quotation for screening-stage DMPK — no email back-and-forth, compare pricing in minutes.

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Case studies

Method development & complex-matrix challenges, solved

Case 01 · In Vitro ADME

CYP450 inhibition profiling for early DDI risk

Profiling a candidate against five major CYP isoforms to flag clinical drug-drug interaction risk before costly development.

  • Pooled human liver microsomes, probe substrates, IC50 derivation.
  • Weak-to-moderate CYP3A4 inhibition flagged — development plan updated.
Case 02 · Bioanalysis

LC-MS/MS method development for plasma PK

Fit-for-purpose method development and partial validation using protein precipitation and MRM detection.

  • Calibration curves and QCs met accuracy / precision acceptance.
  • Method applied to subsequent PK sample analysis — robust data.
Case 03 · Biotherapeutics

ADC stability in human plasma — linker hydrolysis

Characterizing intact ADC stability and free payload release over time to support ADC pharmacokinetic studies.

  • Free payload increased over incubation — linker instability confirmed.
  • Validated sample handling and stabilization designed for ADC bioanalysis.
View all case studies
DMPK knowledge

Why DMPK data quality decides your program's fate

Practical answers to the questions discovery teams ask us most — and how we answer them in the lab.

What is metabolic stability and why does it matter?

Metabolic stability measures how fast your compound is cleared by liver enzymes (microsomes or hepatocytes). High clearance can mean poor oral bioavailability and short half-life — early screening saves you from progressing a doomed lead.

What is plasma protein binding (PPB)?

Only unbound drug can cross membranes and reach its target. High binding (low free fraction) affects efficacy, volume of distribution and dose projection — we measure it by equilibrium dialysis and report the free fraction directly.

Why screen CYP450 inhibition early?

If your compound inhibits a major CYP isoform (e.g. CYP3A4), co-administered drugs may reach toxic levels. CYP inhibition IC50 data flags clinical drug-drug interaction risk long before first-in-human.

Which species should I use for PK?

It depends on your question: rodents for fast screening, beagle dog and NHP for large-animal PK/TK and human projection. We support mouse, rat, beagle, minipig and NHP — with naïve or non-naïve large animals.

Delivery workflow

Fast, transparent delivery in five steps

Reports typically within 5 working days.

1

Intake

Scope, sample matrix & requirements confirmed

2

Design

Protocol & method plan confirmed

3

Execute

In vivo study & bioanalysis

4

Report

Data QC, statistics & full report

5

Support

Regulatory queries & follow-up

Get an instant quote for your DMPK study

Select your species, study design and sampling — our online quote builder prices it instantly. Large animals available as naïve or non-naïve, and every unit price is transparent.

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Email
zhanyuan@strivita-biotech.com
Phone
+86 181 7030 0832
Location
Suzhou Industrial Park, China
Quality
GxP-aligned · ALCOA+