Bioequivalence and Bioavailability Forum • Alendronate Urine PK

nasir
☆

Jordan,
2013-09-18 00:15
(4252 d 18:57 ago)

Posting: # 11509
Views: 5,159

Alendronate Urine PK [PK / PD]

Hi All;

We did alendronate BE in urine on 56 subjects, but ended up with one or two missing urine samples in about 28 subjects in test and/or refernce.

Hence, the comulative amount excreted (Ae) wont be accurate in those 28 subjects due to lost drug samples.

What to do :confused:

: delete 28 subjects from the study or assume that the lost drug is random among test and reference, and do calculations of Ae as usual?

Unfourtunately current US FDA guideline did not help since it asks for BE in plasma.

Thanks for your guidance.

Helmut
★★★

Vienna, Austria,
2013-09-18 00:35
(4252 d 18:37 ago)

@ nasir
Posting: # 11510
Views: 4,260

Alendronate Urine PK

Post reply

Hi Nasir,

please clarify: Are the samples missing (e.g., vial broken and no back-up available) or do you mean that volunteers were not able to urinate at the scheduled time? The latter is not a problem (Ae as usual). On the other hand missing samples are a serious problem…

—
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Helmut Schütz

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Science Quotes

nasir ☆ Jordan, 2013-09-18 10:11 (4252 d 09:01 ago) @ Helmut Posting: # 11511 Views: 4,207	Alendronate Urine PK Post reply
	Hi Helmut, Missing data was due to etheir broken vial or due to unreliable assay values of a urine samples with the remaining samples not adequate to repeat the assay. Thank you Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]

Dr_Dan ★★ Germany, 2013-09-18 11:22 (4252 d 07:50 ago) @ nasir Posting: # 11513 Views: 4,192	Alendronate Urine PK Post reply
	Hi Nasir Sorry, but I do not understand why you conducted a BE study with alendronate using urine samples. So the question remains even if you are able to perform a statistical analysis what would be the use of this study? The study will not be accepted either by FDA or EMA and I guess in other countries accordingly. Kind regards Dan — Kind regards and have a nice day Dr_Dan

nasir ☆ Jordan, 2013-09-18 12:08 (4252 d 07:03 ago) @ Dr_Dan Posting: # 11515 Views: 4,200	Alendronate Urine PK Post reply
	Hi Dan, Your concern is valid. To make my self clear, the study was conducted about 3 years ago before new guideline recommendation on plasma. Thank you Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]