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Evaluate the CRO's drug formulation capability.

CROs are provided with all of the drug specifications on stability, preparation, and safety. With a highly water soluble drug it is rare to have a formulation issue. But as you know, drug solubility is commonly a challenge and even though the formulation will have already been defined at your site, drug preparation in a different research facility can go wrong. To avoid problems we at SSPCC recommend that you:

  • Review CRO staff drug formulation training and experience.
  • Audit drug preparation on-site prior to initiating dosing. A dry-run to iron out the kinks may be well worth the investment even though it may seem like an extra resource burden. You will want to review the SOPs for this activity anyway, and since they cannot be removed, the only way to review is on-site.
  • Arrange analysis, if deemed appropriate, where there are significant test substance stability and homogeneity issues.
  • Provide in-depth, detailed instructions of the steps required for your drug preparation in addition to the standard MSDA documentation for any drug that has formulation difficulties. Small things like type of homogenizer and/or the use of pestle and mortar can be significant.
  • Consider providing the vehicle along with the drug to avoid any chance of incompatibilities.
  • Verify certification of analysis and expiry dates. We have experienced instances where a delay in the initiation of the study has caused the drug substance to be out of specification. For example, one of my clients was rescheduling a delayed study, and I found that the drug would be out of specifications by the middle of the study. If we hadn't found this oversight, the entire drug study would have needed to be redone or completely scrapped. You need a valid certification to be GLP compliant.

Even though you're dealing with organizations that do this all the time, inaccuracies or missteps can occur. Evaluating drug preparation is a small insurance towards the successful outcome of your study.

Dr. Caroline Bell
Founder and CEO


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