Toxicology

A Tale of One Happy Client about Lightning-fast PK Data (i.e., QPS Doing What We Do) - September, 2014

Over the past year, QPS Taiwan’s CTPS (Center for Toxicology and Preclinical Sciences) toxicology unit and NKSP (Nan Kang Software Park Biotechnology Plaza) bioanalytical lab have been conducting the perquisite genetic toxicology and general toxicology IND-enabling studies for a US sponsor.

The Sponsor, who plans to submit an IND to the US FDA before the end of the year, needed a follow-up PK study for formulation selection - and they needed it pronto. To oblige, QPS-Taiwan performed a 3-arm Beagle dog PK study with the following lightning-fast turnaround based on US time:

  • 4th Aug (Monday) Request from Sponsor received
  • 9th Aug (Saturday) Study design confirmed and proposal signed
  • 14th Aug (Thursday) Test article received
  • 19th Aug (Tuesday) Protocol signed by Sponsor
  • 21th Aug (Thursday) First dosing day
  • 5th Sep (Friday) In-life completion
  • 7th Sep (Sunday) Delivery of QC'ed Bioanalytical data

Note that the time from protocol signing to data delivery was only 3 weeks! The in-life unit was able to start the PK study rapidly with the on-site dog colony, followed-up by the bioanalytical unit working through a holiday weekend to get the sponsor their formulation data and issuing QC’d MDT ahead of schedule.

Here’s what the Sponsor had to say:
“Hi J, wow, WOW, thanks so much to Kerry and team for turning the samples so quickly! I saw that samples were received on Sep 5, and it’s so impressive that the team processed them in a single day (knowing also the BA team is fully booked!). I really appreciate it, and I thank the team for the effort to also start the run and monitor it over the holiday... Great study, thanks to Yu-Wen and Kerry, well done, timely, useful and so very much appreciated!”

Kudos to the team! And to the Sponsor, glad we could help.

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