Health Canada: Data format [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-15 13:32 (2264 d 16:15 ago) – Posting: # 18172
Views: 3,358

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does anyone have experience with the 2004 „Draft Guidance for Industry.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

states

• 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
73 visitors (0 registered, 73 guests [including 9 identified bots]).
Forum time: 05:47 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5