Bioequivalence and Bioavailability Forum • Topicals, generic

Topicals, generic [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-04-01 10:03 (4415 d 13:50 ago) – Posting: # 10319
Views: 25,405

Good morning folks,

It seems the new guideline hasn't removed the need to conduct a BE study (for safety reasons) for opthalmic solutions that may contain an ingredient that is absorbed systemically. Has anyone successfully argued against this? It appears it's still fine to obtain a biowaiver for the efficacy part, but not for safety?! To me, this is a WTF moment, but maybe I'm missing out on something. Does that make sense to anyone (for a solution)?

Thank you,
Outlaw

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, generic ioanam 2013-04-01 07:51
      - Topicals, genericThe 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