Bioequivalence and Bioavailability Forum

Topicals, generic [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-03-31 21:26 (4416 d 02:35 ago) – Posting: # 10317
Views: 25,479

Hi ioanam,

further to what Helmut just said I can mention that inhaled and intranasal drugs also somehow are often classified as topicals.
Many inhaled topicals () are regulated by this beauty of a guideline.

In many cases you cannot call them generics (and cannot assume substition is granted like a typical generic) if they are submitted for EU approval. Check directive 2001/83 article 10.3.

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, genericElMaestro 2013-03-31 19:26
      • Topicals, generic ioanam 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