Combination Drugs

Increase the power to treat disease.

Combination drugs, also known as “fixed-dose combinations” (FDC), provide real clinical benefits when their components work synergistically to enhance their therapeutic effectiveness, improve safety, or minimize the potential for abuse. FDCs are defined as two or more drugs that are packaged together for their administration as a single dosage at a fixed concentration for each component. Each component can be a combination of previously approved drugs, new chemical entities, or both, with each situation requiring its own scope of preclinical studies. At KreaMedica, we work with you to define the preclinical strategy that addresses the pharmacologic and toxicologic needs of your combination drug for its advancement into the clinic.

Unique Challenges within Combination Drug Products Program Development.

The Pharmacokinetics and Pharmacodynamics of FDCs may differ from their individual components.
FDCs have the potential for toxicologic interaction between their components, potentially altering their safety profile and increasing the risk of cumulative toxicity.
Each Investigational New Drug in the FDC must be evaluated individually and in combination to evaluate cumulative toxicity.
The selection of preclinical animal models and dosing schedule must account for the mechanism of action and interactions of the individual components.
Regulatory approval requires demonstrating the advantage of an FDC over its individual agents.

KreaMedica’s Solutions

Our team of expert toxicologists and regulatory consultants can help you design the best strategy for your preclinical portfolio.
We help you design your ADME program by analyzing the qualities of your combination drug product and its potential for cumulative toxicity.
Our scientific team can guide the selection of relevant preclinical model(s) for your in vivo
We help you identify the relevant in vitro and in vivo models for safety pharmacology studies.
At KreaMedica, a program manager and a preclinical scientist are assigned to your studies and work as an extension to your team, following your studies from their design to their final report.

Truth in Numbers

140+

Development Programs

85+

Sponsors Who Trust Us

2+

Decades of Experience
Helping Biotech

Testimonials

Don’t take our word for it.

James L. Ellis, Ph.D.
Nocion Therapeutics, Inc., Chief Scientific Officer

They provided valuable insights and recommendations while seamlessly integrating into our team.

I have had the pleasure of working with KreaMedica on several programs. They proactively identified and addressed issues and provided regular updates to ensure everyone was on the same page. Their attention to detail and willingness to take ownership of the project’s success makes them invaluable partners. They are great to work with, and I would highly recommend them to anyone looking for a drug development partner.

Brian Jones
Respirion Pharmaceuticals, Chief Operating Officer

KreaMedica was an essential complement to our virtual team.

They supplemented and filled in gaps in our internal network and worked well with our advisors. They truly wanted to contribute to and be part of the project’s success. I highly recommend Claude, Poulomee, and Rudi as reliable partners for planning and executing toxicological and bioanalytical projects.

Ron Wolff
RK Wolff Safety Consulting Inc., Principal

The combination of all their perspectives made a tremendous difference.

I have worked with KreaMedica for many years, and I must credit them for the team’s talent, professionalism, and chemistry. That doesn’t happen by accident. As a consultant, I rely on them as the first line to monitor studies and provide proactive solutions when required.

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