saipraveen7 ☆ India, 2013-07-24 18:45 (4325 d 04:08 ago) Posting: # 11050 Views: 4,591 |
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On what basis appropriate matrix (whole blood, plasma, serum, urine, CSF etc.) is selected for method development and sample analysis in BA/BE studies - P.Sai Praveen Bio-analytical Chemist |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2013-07-24 20:34 (4325 d 02:19 ago) @ saipraveen7 Posting: # 11054 Views: 3,847 |
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Hi Sai! ❝ On what basis appropriate matrix (whole blood, plasma, serum, urine, CSF etc.) is selected for method development and sample analysis in BA/BE studies Depends on the PK of the drug and the limitations of the analytical technology.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
jag009 ★★★ NJ, 2013-07-25 01:02 (4324 d 21:50 ago) @ Helmut Posting: # 11057 Views: 3,818 |
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Hi Helmut, ❝ • Urine: History. Haven’t seen a method (in BE of course; PK is another cup of tea) for ages. BE based on urine data is only reasonable if the drug is excreted unchanged (low first pass and/or presystemic metabolization). Was used for bisphosphonates in the past (BA <2%). Since it is very difficult to assess the rate of absorption from urine, EMA accepted extent of absorption from urine (cumulative amount) but still wanted to see Cmax from plasma. KCl? john |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2013-07-25 02:05 (4324 d 20:47 ago) @ jag009 Posting: # 11059 Views: 3,877 |
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Hi John, ❝ ❝ • Urine: History. ❝ ❝ KCl? Oh no, how could I forget such a goody? Thanks for reminding me. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |