Ing. Helmut Schütz
Guestbook
Dear Helmut,
I think that the ANVISA guideline links has been broken as they too updated the website look
Thank you,
Regards,
MGR
Dear MGR,
ANVISA’s website is a mess. Have you seen the note in the introduction of the respective section of the guidance-collection? Since I don’t understand Portuguese I essentially have given up fighting myself through ANVISA’s site. I even asked members of ANVISA personally for help – without effect. They change the structure every couple of weeks (!) – I simply don’t have the time to adapt to this nasty issue. Sorry.
Helmut
What is the meaning of Biowaiver in bioequivalence studies and when it is applied or used under which conditions.
Dear Nirav,
questions in the BEBA-Forum only, please.
Helmut
sorry and thanks you sir i forgot my forum user name and password so only i send thanks for your reply
Dear Karthik,
no problem. Click on "Log in", type in "Karthik" and click "Forgot your password?" below. For instructions see here.
Helmut
This site is very useful for me.
Really, I learnt a lot.
The word "thanks" is not enough to express my Gratitude.
too good
dear sir
we want to calculate intersubject CV from reference literature in that they given mean, CI we calculated intra CV from CI? then how to calculate Inter CV?
how to calculate inter subject CV from arithmetic mean or Standard devation? its possible to calculate?
or we can able to calculate inter subject CV from intrasubject cv?
pls guide ME thanks in advance
Dear Karthik,
questions in the BEBA-Forum only, please! Some hints:
• CVintra from a cross-over’s CI → possible
• CVinter from mean ± SD → not possible (only ≈ CVtotal)
• CVinter from CVintra → not possible
BTW, why do want to get CVinter? For a cross-over you need CVintra and for a parallel design CVtotal.
Best regards, Helmut
thanks for the wonderful web page.
You are really patient answering messages in the guestbook!
best wishes.
Marival Bermejo
Universidad Miguel Hernandez
Alicante
Spain
Hi Marival,
nice to get a sign of life from you! Sorry for the late answer; I don’t read the guestbook very often. ;-)
Hope to meet you again – somewhere, sometime.
Take care,
Helmut
2012-01-03
DEAR SIR,
I AM SEARCHING FOR DATA REQUIREMENTS FOR BIOEQUIVALENCE STUDIES TO THE REGULATORIES, AS WHAT IS THERE REQUIREMENT OF DIFFERENT REGULATORIES
Dear Guruprasad!
Why are you SHOUTING? Or is your [Shift]-key jammed? The Forum is six buttons to the left – here is the Guestbook.
Helmut
Dear,
Do you have any experience in bioequivalence studies in russia and mexico, If these bodies accept bioequivalence studies conducted in other countries like TGA and ANVISA.
Regards
VK
Dear Vikas,
questions in the BEBA-Forum only, please. Login with your ‘old’ account (user name: Vikas Kumar); I have corrected your e-mail address…
Helmut
Hi,
Excellent work done by Helmut. I would like to know, having an experience of around 10 years in BA/BE studies for doing the pk and statistical analysis, report writing, a certified SAS base programmer, can a person sign on the statistical report?
Thanks.
Deer Neera,
IMHO yes (my statistical reports were never questioned by any authority in the past 30+ years). No guideline I know of asks for a degree in biostatistics. Of course your ‘training on the job’ should be documented. See also this post in the BEBA-Forum – which is a better place for asking questions to a larger audience in the future.
Helmut