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Coordinated and Early Planning Makes Light Work of Complex Bioequivalence Study
Long known for its expertise in regulatory affairs, Novotech recently assisted a European based generics manufacturer plan the development of a new line of products for market introduction in Europe and Australia.
Retained initially as regulatory consultants, Novotech evaluated the development work completed to date, including publicly available data from other formulations of the same drug, to propose a study design for this very long half-life drug to satisfy regulatory requirements internationally.
Having to meet tight study completion timelines due to third party licensing and contractual obligations of the client, Novotech was subsequently retained for conduct and management of the bioequivalence study. Bringing together its network of clinical and analytical laboratory facilities, Novotech rapidly engaged one of its select list of clinical partners in Australia to undertake the clinical part of the study, the dosing period for which was in excess of 12 weeks. With no subject dropouts, the study moved seamlessly to laboratory assay phase some three months later. Requiring a validated assay developed specifically for this project, the experienced Novotech project management team worked with an overseas based laboratory, a long standing partner of Novotech’s with whom many other projects had previously been completed, to conduct the laboratory analysis in under 6 weeks.
Back at Novotech’s head office in Sydney, our data management and regulatory affairs teams, using a validated industry standard WinNonlin® platform, performed the pharmacokinetic and statistical analysis of results, preparing a fully ICH compliant study report in less than two weeks from completion of laboratory analysis.
At the end of the day, a complex study combined with very tight timelines, was able to be conceived, conducted and reported on time and to budget using Novotech’s highly responsive network of outside partners and inhouse regulatory and project management expertise.
After all, there is no substitute for experience. |
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