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Hello,
Has anyone used dosing solution (leftover dosing solution from CRO after study) to quantitate TK samples? In that case, you would use your dosing solution (1 mg/mL drug) in formulation to make your analytical standard curve. Normally, your stock standard for calibration curve is prepared independently from your dosing solution.
Is this a good practice to use your dosing solution to quantitate your in-life TK samples?
Regards,
Anila
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The following message was posted to: PharmPK
Anila,
A dosing soultion of 1 mg/ml can provide a narrow dose range( mg/kg) for the the Toxicokinetic studies, keeping in view the dosing limits of rodents, non rodent and the primate species. So for a typical TK studies (ranging ~ 2000mg/kg) you normally need dosing solutions of high strength.
Secondly, if your formulation contains different excipents,then it is likely to cause interfernce during bioanalysis.
Hence, usage of leftover dosing solution for sample analysis is not a good practice indeed.
Regards,
Pradeep Sharma
Metabolism and Pharmacokinetics
Ranbaxy Research Laboratories
Gurgaon
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