Topicals, generic [Regulatives / Guidelines]
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.
Pass or fail!
- 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
- Clarity on waiving multiple dose study Tina 2013-05-15 14:19
- SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
- 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