Log in
Register|
Tina ★ India, 2014-02-25 13:39 (4502 d 06:22 ago) Posting: # 12495 Views: 4,018 |
|
|
Dear all, Is it required for Bioequivalence study of topical steroids to comply with the 'Guideline on bioanalytical method validation', (21 July 2011, EMEA/CHMP/EWP/192217/2009)? I always thought that the specific FDA guideline covers the specific validation of the chromameters involved in a topical steroid BE study. Look forward to advise from the forum members. |
|
ElMaestro ★★★ Denmark, 2014-02-25 22:53 (4501 d 21:09 ago) @ Tina Posting: # 12498 Views: 3,358 |
|
|
Hello Tina, ❝ Is it required for Bioequivalence study of topical steroids to comply with the 'Guideline on bioanalytical method validation', (21 July 2011, EMEA/CHMP/EWP/192217/2009)? Bioequivalence and topical steroid... this doesn't sound right to me if we talk EU, which I assume we do since you quote the EU guideline on bioanalytics. In EU bioequivalence is tightly linked to systemic PK, which in all likelihood isn't on the menu for a topical steroid which presumably is locally acting. The guideline you quote is intended for measurement of analyte concentrations in biological matrices. With a locally acting steroid you are likely facing a PD-endpoint so I think the bioanalytical guideline does not apply. ❝ I always thought that the specific FDA guideline covers the specific validation of the chromameters involved in a topical steroid BE study. How did FDA's guideline now enter the discussion? I don't get the meaning here. — Pass or fail! ElMaestro |
|
Tina ★ India, 2014-02-26 13:23 (4501 d 06:39 ago) @ ElMaestro Posting: # 12501 Views: 3,392 |
|
|
Dear ElMaestro, FDA Guidance Topical Dermatological Corticosteroids-In vivo bioequivalence (Issue Date: 2 June 1995) has a section on vasoconstrictor assay which explains about validation and standardization (linearity, accuracy, precision and sensitivity). We recently received an RFI from a EU regulatory body asking whether the vasoconstrictor bioassay complies with the EU bioanalytical guideline. Kind regards, Tina 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] |
|
ElMaestro ★★★ Denmark, 2014-02-26 13:35 (4501 d 06:26 ago) @ Tina Posting: # 12503 Views: 3,357 |
|
|
Hi Tina, ❝ We recently received an RFI from a EU regulatory body asking whether the vasoconstrictor bioassay complies with the EU bioanalytical guideline. That's an easy one then. It's a trick question. Just tell them it doesn't  Imagine.... what is a QC sample is in vasoconstrictor assays, how would we do incurred sample re-analysis (yeah right, let's ask the subjects to come back to the clinic for more visits??!?), what about stability and freeze-thaw cycling etc etc. Just validate the chromamolophystic constrilotractor normally. And pardon me if I am having the terminology slightly wrong  .— Pass or fail! ElMaestro |
|
Tina ★ India, 2014-02-26 17:10 (4501 d 02:52 ago) @ ElMaestro Posting: # 12514 Views: 3,369 |
|
|
Dear ElMaestro, ❝ 'That's an easy one then. It's a trick question. Just tell them it doesn't' We said that the EU guideline wouldnt be applicable and got the same question back. Now said that it complies and the assessor didnt have any further question! Kind regards, Tina |
|
nobody nothing 2014-02-27 15:18 (4500 d 04:43 ago) @ Tina Posting: # 12526 Views: 3,335 |
|
|
❝ We said that the EU guideline wouldnt be applicable and got the same question back. ❝ Now said that it complies and the assessor didnt have any further question! Names, we wanna hear names!  |
Ing. Helmut Schütz