Blog & Resources Camargo Blog July 11th, 2018

Nonclinical Study Requirements for 505(b)(2) Development

On June 1, 2018, Camargo Pharmaceutical Services celebrated our 15th Anniversary. For this week’s blog, Camargo co-founders, Dr. Ruth Stevens, Chief Scientific Officer and Executive Vice President, and Ken Phelps, President, discuss an important question Camargo often hears from prospective clients: What Nonclinical Study Requirements Do I Have for my 505(b)(2) Drug Development Project?


We were talking about the guidances for clinical studies in our prior podcast blog. For this podcast, we are discussing the guidances for nonclinical programs, because the same applies to guidances for nonclinical programs. How do we look at those for 505(b)(2) drug development? Let’s take for example that I’m trying to make a modification for a drug that has already been approved in the United States, maybe it has been on the market for some time. How do we go about thinking about the nonclinical study requirements?

Dr. Stevens:

We start with the guidances as they clearly list the studies that need to be done for nonclinical development. We look in the published literature to find out what is already known about the safety of this drug product from a nonclinical perspective. What type of nonclinical studies have been done? What has been the exposure? Have they gone above the dose that the product that the sponsor wants to develop so that we know the safety margins? We look at the guidances that are out there for the 505(b)(1) products and look at what we can fill in from the published literature. There is not a need to do all of the nonclinical studies that are put out there in the guidances. It comes down to what do you know about your drug substance from the public literature.


Just as for clinical, we know that we do not have to do some of the studies. Maybe some of the studies have to be changed because of recent knowledge. The other idea I would like to explore is the idea that nonclinical—we often call it preclinical, because usually it means before they do the clinical—experience that we have had with conducting some of these nonclinical requirements that we do determine are needed after clinical or during clinical. Tell us a little about our experience pushing those out further in the development timeline.

Dr. Stevens:

Again, it all depends on what we know about the safety of the drug substance. We look if it has been exposed already in other animals or in humans, and we look at the adverse events that have been reported with this drug substance. If there is a good safety profile and a good margin of safety, we ask the FDA routinely if it can be done in parallel with clinical trials prior to opening an IND. Sometimes we open the IND with a clinical study prior to doing any nonclinical work.


The fact that you can open up an IND and get into clinical early is an important thing for many of our sponsors. It’s an efficient use of capital. We can get into proof-of-concept early and keep the costs of startup also lower. To be able to show proof-of-concept before we have to get into maybe some of the expensive nonclinical studies. That is a lot different than a 505(b)(1) development program, isn’t it?

Dr. Stevens:

It is absolutely different. In 505(b)(1) development, you have to do a number of nonclinical studies to show the safety of the drug product going forward.

I do want to state that it is not a data dump with going to the FDA with all that you find in the literature. It is very important to look at the studies and determine the level of evidence. It is really finding the data that supports for human safety.


As the clinical program does not necessarily follow FDA guidances, neither does the nonclinical program. It depends on what is available in the public domain. It is also informed by the public experience on the drug, what we can get from adverse reports that inform us on the toxicology program. It also informs the scope and timing of those studies. It has been our experience that we have been able to push many of the tox studies down the road, which makes those programs very capital-efficient and time-efficient.


Every 505(b)(2) development program is unique and different. Camargo can help you evaluate your nonclinical programs and get your project to approval and market in the most cost- and time-efficient manner. To learn more, contact us.

Categories: Nonclinical / Regulatory

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