drsinghs
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India,
2012-07-13 15:18
(5098 d 21:55 ago)

Posting: # 8944
Views: 5,542
 

 Buspirone Intra_CV & Sample size for Fast & Fed Study [Design Issues]

Dear All,

Can anybody share Buspirone Intra_CV & Sample size for Fast & Fed BE Study?

Thanks & Regards,
drsinghs


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2012-07-13 16:31
(5098 d 20:42 ago)

@ drsinghs
Posting: # 8945
Views: 4,703
 

 Buspirone CVintra

Dear drsinghs!

❝ Can anybody share Buspirone Intra_CV…


We1 found 50.9% for AUC in 18 subjects (20 mg IR fasting). Five out of the 18 subjects were slow metabolizers resulting in up to 20fold higher AUCs. Be prepared in bioanalytics to cover a wide calibration range. Sorry, I don’t have data on Cmax any more (last century…). ;-)
Steinijans et al.2 reported 32% for AUC and 41% for Cmax in 19 subjects after 4×5 mg IR tablets (no indication of the pranial state).


    References:
  1. Eichinger A, Schütz H, Nitsche V. Determination of Buspirone in Plasma by HPLC with Solid-Phase Extraction and On–Line Precolumn Trace Enrichment and its Application to a Pharmacokinetic Study. Europ J Drug Metabol Pharmacokin. 1990;15(1):P234.
  2. Steinijans VW, Sauter R, Hauschke D, Diletti E, Schall R, Luus HG, Elze E, Blume H, Hoffmann C, Franke G, Siegmund W. Reference tables for the intrasubject coefficient of variation in bioequivalence studies. Int J Clin Pharm Therap. 1995;33(8):427–30.

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drsinghs
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India,
2012-07-23 13:49
(5088 d 23:25 ago)

@ Helmut
Posting: # 8969
Views: 4,479
 

 Buspirone CVintra

Thanks HS, I got the full text of first article. However I could not find 2nd one as listed below. Can someone help me with the full text of this article?

Eichinger A, Schütz H, and V Nitsche

Determination of Buspirone in Plasma by HPLC with Solid-Phase Extraction and On–Line Precolumn Trace Enrichment and its Application to a Pharmacokinetic Study



Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Helmut
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Vienna, Austria,
2012-07-23 14:47
(5088 d 22:26 ago)

@ drsinghs
Posting: # 8970
Views: 4,510
 

 Buspirone CVintra

Dear drsinghs!

❝ Can someone help me with the full text of this article?


Was a poster at the “Fourth European Congress of Biopharmaceutics and Pharmacokinetics”, Geneva, April 17–19, 1990. I’ll send you a copy.

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drsinghs
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India,
2012-07-23 14:57
(5088 d 22:16 ago)

@ Helmut
Posting: # 8971
Views: 4,383
 

 Buspirone CVintra

❝ I’ll send you a copy.


Thanks HS
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