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Where Cost and Quality Meet with Compliance Obligations
Once a generic product is registered, it’s easy to assume no more clinical development work will be required. Unfortunately, sometimes there is no choice. A long standing client of Novotech’s approached the company with a situation where a block-buster generic drug was going to be sourced from new sites and there was to be a forced change in formulation. Moreover, the client only had 6 months of guaranteed supply from the original source with the registered formulation. To top it all off, the drug had three different strengths and the new formulations were not direct-scales of one another!
Working rapidly with the client’s logistics and regulatory teams, Novotech assigned a project team tasked with coming up with an overall program design that would allow it to run three concurrent bioequivalence studies, one for each strength of the drug, in a staggered approach at the same clinical facility. Whilst this allowed a steamlining of site initiation and study team training processes and costs, it also meant the Novotech team and the site had to work extremely closely together to ensure each study was able to be run as an independent project with no possibility of a mix-up given three simultaneously run studies with the same drug.
In the event, through careful coordination and an innovative approach to study management processes, over 4,000 samples were collected across the three studies in a 6 week period and shipped off for laboratory analysis.
As drug assay results subsequently confirmed, the studies were conducted impeccably with no unpredictable outcomes. Given the similarity of the studies, continuing with its approach of staggered but simultaneously run projects, Novotech data management and regulatory staff set to the task of pharmacokinetic modelling and analysis of all three studies as one. This allowed a sizable streamlining of the workload involved resulting in crucial time savings for the client.
Five months after being commissioned on this project, three completed BE studies were submitted to the regulatory authority confirming bioequivalence of the new formulations of these marketed drugs. The client was able to place a final order of the original formulation prior to its deadline to see it through the regulatory review process. The new formulations were all subsequently approved with no interruption in supply. A happy outcome all round!
After all, there is no substitute for experience. |
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