Bioequivalence and Bioavailability Forum

Topicals, generic [Regulatives / Guidelines]

posted by ioanam – Romania, 2013-04-01 09:51 (4832 d 23:08 ago) – Posting: # 10318
Views: 28,457

Thank you very much for your responses.

I consider that EMA must present a clear guideline for this type of products in order to have the same procedure in all EU countries because in some countries is still possible to obtain MA as a well established use product, while other authorities requires more and more trials. This is not ok.

We are all equal, but some are more equal than others (Sorry for this satirical quote adapted to this situation).

Wish you a beautiful week,
Ioana

Complete thread:

• Draft EMA MR formulations GL published! Ohlbe 2013-03-15 12:10 [Regulatives / Guidelines] 
  • Housekeeping suggestions Helmut 2013-03-15 13:28
  • Scaling for pAUCs Helmut 2013-03-15 14:19
  • Draft EMA MR formulations GL published! ioanam 2013-03-30 17:54
    • Topicals → 1995 NfG Helmut 2013-03-30 22:51
    • Topicals, generic ElMaestro 2013-03-31 19:26
      • Topicals, genericioanam 2013-04-01 07:51
        • Topicals, generic The Outlaw Torn 2013-04-01 08:03
  • Clarity on waiving multiple dose study Tina 2013-05-15 14:19
    • Hey, it is just a draft! Helmut 2013-05-17 18:49
      • Critical review of García-Arieta et al. (2012) Helmut 2013-06-29 19:44
  • SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
    • SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
      • SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
        • SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
          • pAUCs, alternative metrics, alcohol Helmut 2013-06-27 14:38
  • tmax (DR & multiphasic) Helmut 2013-06-22 01:15
  • Presentations of the EUFEPS meeting Helmut 2013-07-15 15:50
  • ⧫ Deadline approaching ⧫ Helmut 2013-08-16 16:41
    • Download comment form Helmut 2013-08-26 11:28
  • Food effect Compliance 2013-08-26 12:04
    • Food effect Dr_Dan 2013-08-26 16:48
  • Variability (MR vs. IR) Helmut 2013-09-12 15:23