Bioequivalence and Bioavailability Forum

Some animals are more equal than others [BE/BA News]

posted by Helmut  – Vienna, Austria, 2014-10-15 05:20 (3854 d 17:39 ago) – Posting: # 13710
Views: 14,067

Hi Lucas,

❝ ❝ It would be worthwhile to go back in time when – apart from ABE – prescrib­ability (by population BE) and switchability (by individual BE) was discussed.

❝

❝ BTW Dr Laszlo Endrenyi gave us a lecture about that recently in a workshop organized by our company at ANVISA.

He is the perfect lecturer for this topic.

❝ He said many good things about you in our lunch/dinner breaks.

Nice to hear. I like him very much and always enjoy meeting him. When he talks about new ideas he uses the word “enthusiastic” at an amazing frequency. His scintillating eyes show that inside he is younger than some members of the e-generation. He performed so much pioneering work and never is arrogant when he says “We have done that already 30 years ago”. What he means is: Don’t re-invent the wheel, let’s move forward to new frontiers!

❝ ❝ The innovator has a database of hundreds–thousands of patients before he gets the approval. If a generic comes in we have a database of millions of patient-years.

❝

❝ Do you think that we can assume that outside of EUROPE/USA/etc also?

Yes.

❝ The reason I'm asking it is that it seems to me that in "3rd world countries" (or using the polite way to call countries like mine: developing countries) I'd not be sure about that, due to late developing of regulations (when compared to EU and US).

Drugs don’t care about regulations. It’s us who fail.
This image on the box was not a clever idea in countries with a high rate of illiteracy:


Is this one more clear?
  

—
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

Complete thread:

• Article: BE-criteria too strict sometimes? Helmut 2014-09-23 12:39 [BE/BA News] 
  • Article: BE-criteria too strict sometimes? Ohlbe 2014-09-23 22:20
    • Risk assessment Helmut 2014-09-24 03:34
      • Risk assessment Ohlbe 2014-09-24 10:22
        • Risk assessment nobody 2014-09-30 17:59
          • Risk assessment Helmut 2014-10-01 13:02
            • Risk assessment nobody 2014-10-01 13:32
  • Are all men born equal? ElMaestro 2014-09-24 11:20
    • Article: BE-criteria too strict sometimes? felipeberlinski 2014-09-24 18:47
    • Some animals are more equal than others Helmut 2014-09-24 19:14
      • Some animals are more equal than others nobody 2014-09-24 20:32
      • Some animals are more equal than others Lucas 2014-10-14 17:02
        • Some animals are more equal than others Helmut 2014-10-14 21:15
          • Some animals are more equal than others Lucas 2014-10-14 22:25
            • Some animals are more equal than othersHelmut 2014-10-15 03:20