Health Canada: Data format [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-15 13:32 (2147 d 03:02 ago) – Posting: # 18172
Views: 3,227

Dear all,

does anyone have experience with the 2004 „Draft Guidance for Industry.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:Which software is HC using? I expect that the results of NCA will not match the standard output of commercial software (e.g., Phoenix WinNonlin) and R-package bear.

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