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RegisterMetadate CD sampling: 24 hours [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-04-12 20:45 (5190 d 19:10 ago) – Posting: # 8417
Views: 5,110
Hi John!
24 hours are long enough to cover >80% of AUC∞. Rochdi et al. (2004)* investigated Metadate CD 10, 20, 30 mg and found (n=23):
CVs were 11.8% for Cmax, 7.7% for AUCt, and 7.6 for AUC∞. I wouldn’t recommend a sample size of >16 subjects. If you want to be on the safe side opt for a Two-Stage Design (accepted by FDA, HPB, and EMA).
❝ Is 36 hour sampling sufficient for a single dose Metadate CD? I checked literature and the t1/2 was about 6.4 +/- 1.4.
24 hours are long enough to cover >80% of AUC∞. Rochdi et al. (2004)* investigated Metadate CD 10, 20, 30 mg and found (n=23):
10 mg 20 mg 30 mg
AUCt (ng×h/mL) Mean±SD 23.91 ±9.54 46.56 ±19.71 70.65 ±28.48
Median 20.66 40.37 63.13
Min, Max 14.71, 51.54 28.00, 105.78 42.86, 157.72
AUC∞ (ng×h/mL) Mean±SD 25.77 ±10.77 50.66 ±21.98 76.03 ±31.62
Median 22.13 43.87 65.20
Min, Max 15.70, 56.51 31.68, 113.50 46.06, 170.00
t½ (h) Mean±SD 5.61 ±0.85 6.06 ±1.42 5.75 ±0.79
Median 5.73 5.65 5.68
Min, Max 4.31, 7.46 3.84, 9.78 4.21, 7.98CVs were 11.8% for Cmax, 7.7% for AUCt, and 7.6 for AUC∞. I wouldn’t recommend a sample size of >16 subjects. If you want to be on the safe side opt for a Two-Stage Design (accepted by FDA, HPB, and EMA).
- Rochdi M, González MA, SJ Hirshey Dirksen
Dose-proportional pharmacokinetics of a methylphenidate extended-release capsule
Int J Clin Pharmacol Ther 42(5), 285–92 (2004)
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Metadate CD sampling jag009 2012-04-12 18:11
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- Metadate CD sampling: 24 hoursHelmut 2012-04-12 18:45
- Metadate CD sampling: 24 hours jag009 2012-04-12 23:44
- Metadate CD sampling: 24 hours Helmut 2012-04-13 00:43
- Metadate CD sampling: 24 hours jag009 2012-04-13 15:59
- power… Helmut 2012-04-13 16:17
- Sounds fine ElMaestro 2012-04-13 16:35
- Metadate CD sampling: 24 hours jag009 2012-04-18 15:57
- Metadate CD sampling: 24 hours ElMaestro 2012-04-18 16:35
- Metadate CD sampling: 24 hours jag009 2012-04-18 17:09
- Metadate CD sampling: 24 hours ElMaestro 2012-04-18 16:35
- Metadate CD sampling: 24 hours jag009 2012-04-13 15:59
- Metadate CD sampling: 24 hours Helmut 2012-04-13 00:43
- Metadate CD sampling: 24 hours jag009 2012-04-12 23:44
- Metadate CD sampling: 24 hoursHelmut 2012-04-12 18:45
Ing. Helmut Schütz