InfantRisk Center: We specialize in lactation research

Partnering to Advance Lactation Research

Developing a medication is a long process. Understanding how that medication is used by breastfeeding mothers and what that means for their infants is an important part of that work.

At the InfantRisk Center, we partner with pharmaceutical companies and research organizations to help answer questions about medications during lactation. Our team brings together expertise in lactation pharmacology, clinical research, human milk analysis, and the care of breastfeeding families.

When evidence is limited, we work with our partners to generate it.

 

Our goal is not simply to conduct a study. It is to help build the knowledge needed to better understand medication exposure during breastfeeding and ultimately provide mothers, babies, and healthcare professionals with better information.

Discuss your study See our study designs
A research center of: Texas Tech University Health Sciences Center TTUHSC Clinical Research Unit, Amarillo Clinical experts across all specialties

Why Lactation Research Matters

Human milk data is now an expectation, not an afterthought

 

The Pregnancy and Lactation Labeling Rule calls for human data on medications in breastfeeding, including how much of a drug gets into breast milk, whether it affects milk production, and what that exposure may mean for a breastfed infant. As more medications are used during breastfeeding, having this information is becoming increasingly important.

Postmarketing requirements

FDA has required lactation studies under section 505(o)(3) of the FD&C Act and is weighing additional circumstances in which they may be required.

PLLR labeling

The Lactation subsection (21 CFR 201.57) calls for drug levels in milk, effects on production, and expected infant exposure — data most labels still lack.

Human subject protection

Every study conforms to 21 CFR Parts 50 and 56 — IRB oversight and protection of human subjects — with IND support available when needed.

The bottleneck we remove

Studies fail on recruitment. Ours don't.

FDA notes that lactation studies frequently fail because sponsors cannot identify potential subjects — often terminating after substantial start-up costs.

The InfantRisk Center is the trusted source of breastfeeding medication information for tens of thousands of nursing mothers. Our apps and national call center connect us directly to women taking the exact medications you need to study — so we recruit and finish. We have never terminated a study for lack of subjects.

 

Direct-to-patient reach. MommyMeds & InfantRisk apps put us in front of 20,000+ nursing mothers every month.

 

National call center. 3× the lactation-exposure call volume of U.S. Poison Control Centers combined.

 

Human Milk Biorepository. A growing, nationwide bank of deidentified milk samples in dedicated research freezers, ready for drug analysis.

 

Enrollment certainty. A national network that protects your start-up investment and your timeline.

Study designs we execute

The full range of FDA-described lactation study designs

We design each study around your drug's pharmacokinetics and dosing — from a simple milk-only screen to a full mother-infant pair study — using the study types and sampling strategies described in FDA's guidance.

Milk-only study

Detects a drug in breast milk and quantifies the amount transferred, and can evaluate effects on milk production. FDA's recommended default unless there's a reason to do more.

Single-dose Longitudinal

Milk & plasma study

Adds maternal plasma sampling for full pharmacokinetics, the milk-to-plasma ratio, and a clearer picture of how much drug reaches milk — including when accumulation is a concern

PK M/P ratio

Mother-infant pair study

Measures drug concentrations in the breastfed infant to assess absorption and safety. The right design when a drug accumulates in milk and is likely absorbed by the infant.

Infant PK Safety

HOW WE WORK WITH YOU

Engagement models to match your program

Turnkey execution, sample generation for your own analysis, or lower-touch consultation, customizable to any level, working directly with pharma or alongside your CRO.

Interventional trials

Full turnkey studies at the TTUHSC Clinical Research Unit, with IND support, or we run the trial and deliver samples to you for analysis.

6–24 months

Non-interventional

Observational "registry"-type data and direct milk-sample collection from women already taking the medication of interest.

3–18 months

Pediatric safety

Any design augmented with long-term observation of pediatric events in exposed infants.

12+ months

Consultation

Study-design and lactation-pharmacology expertise through our Sponsorship program for lower-touch needs

Flexible

CONTACT US

Start a conversation

Tell us about your drug and your regulatory need — our research team will follow up directly.

We don't just generate data. We read it right.
 

Correct interpretation. Having run more medication-in-lactation studies than any lab in the world, we know how this data behaves. Other labs can produce the numbers but draw the wrong conclusions — our experience is in how the data gets read.

 

Independent validation. We review and validate lactation data produced by other labs, so you can trust the analysis behind a submission.

 

Specialty depth. Through TTUHSC we bring in clinical experts in the disease state at hand, alongside our lactation-pharmacology core.

Looking for breastfeeding drug information for yourself? Please don't use this form. Call our phone-center advisors Monday–Friday, 8 AM–3 PM at 1-806-352-2519. Personal medication questions are not answered here.
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