Health Canada: Data format [Regulatives / Guidelines]
does anyone have experience with the 2004 „Draft Guidance for Industry. Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format”?
Appendix B: Computer Format for the Submission of Data for Comparative Bioavailability Studies
2. Detailed Specifications
• Concentrations below the limit of quantitation (LOQ) should be entered as 0.0.What? Also strange:
The following provides an example of a hard copy of the data set and should be included with the submission:
01 AB 1 A 000.00 000.002 052.0123 095.03 122.20 .4 065.15 046.24 019.20 014.99 000.00 000.00
2 Concentrations below the limit of quantitation (LOQ) should be entered as 0.0.
3 The entered drug concentrations must be the measured (uncorrected) concentration and should not be below the lowest or above the highest nominal concentrations of the standard curve.
4 Missing data must be entered as a period (.).
What I don’t get:
- The format of the second file does not allow for giving the actual sampling times (only the scheduled ones in the first file).
- BQLs as zero? Whilst it makes sense to set BQLs before the first measured concentration to zero I’m not so sure about later ones.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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