The integrity of any Phase I clinical program relies heavily on the production, supply and analysis of quality dose formulations. Historically, drug doses have been formulated, manufactured and analyzed at the contract manufacturer, which typically adds significant time and expense given the small volume and the regulatory expectations at Phase I. One solution that is becoming widely practiced is combining extemporaneous preparations at the clinical research unit with independent dose analysis. It’s a one-two punch that not only saves time and money, it provides an extra assurance of quality.
Pharmacies are nimble
Contract manufacturers are built for the scale and regulatory requirements of a large Phase III clinical trial. Volume is their game. In Phase I, volume is overkill and leads to additional time and cost. Compounding within the clinic research unit provides real-time, flexible solutions leading to faster and more efficient availability of investigational product.
Compounding adheres to USP<797> and USP<795> requirements for sterile and non-sterile preparations in the US, and Good Manufacturing Practices in the EU/UK. More importantly, the pharmacist must have the expertise to understand the nuances inherent in the formulation. It may not sound exciting, but expertise requires skill, experience, processes, training, and documentation.
Support systems assure quality
Think of pharmacy support in two ways:
1. Analytical Support: Assessing the quality, stability and potency of clinic-formulated human doses lends an extra level of assurance that many US pharmacies don’t offer. This practice is already in place in the UK and is regulated under MHRA. It’s a good practice and is core to removing unnecessary risks. Regardless of when similar guidelines are established in the US, we’ve had a dedicated dose analysis laboratory supporting our clinics for about 10 years, and it’s become a standard practice with our clients.
2. Formulation Support: Whether assistance is needed in developing your final formulation or evaluating the compatibility of the drug product with containers and apparatuses used during administration or storage, having an experienced partner offers continuity and consistency. When the success of your clinical trial is at stake, consistency within our team gives you assurance that the work will be completed correctly the first time.
Exceptional clinical research units view their pharmacy and pharmacy support systems as key drivers in delivering speed, efficiency, safety, quality and consistency. At Covance, our pharmacy teams have been growing, evolving and delivering on that promise for over 35 years.