Case Study

Case Study: Pharmacokinetics - Client Wins With Unique Camargo Methodology

Source: Camargo Pharmaceutical Services

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Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks

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Challenge Demonstrate equivalency of clinical and commercial batches of the same drug
Details The FDA challenged a client company's drug equivalency claims, so the firm turned to Camargo for expert assistance. Camargo's team of experts in CMC, pharmacokinetics and toxicology addressed this problem with a unique solution: the drug equivalence was demonstrated using interspecies scaling. The team used the available primate data to create accurate projections about the drug equivalency, rather than taking traditional approaches which would have required further studies. The result: positive equivalency results and a compelling presentation to the FDA.
Value In addition to the FDA presentation, Camargo helped the client develop much greater insight into the overall drug development strategy. The interspecies scaling data was exhibited in a poster presentation at a major medical meeting, and investor confidence in the sponsor company soared. In addition, Camargo's work represented a cost savings of approximately $350,000, as some of the client's planned drug equivalence studies were no longer required.

Click Here To Download:
Brochure: 505(b)(2) — Who Says You Can't Teach An Old Dog New Tricks