Bioequivalence and Bioavailability Forum • BE study requirements for Opthalmic and Otic suspensions

BE study requirements for Opthalmic and Otic suspensions [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-11-25 13:27 (5331 d 05:40 ago) – Posting: # 7721
Views: 5,418

Hello Sonu,

❝ As per the individual product bioequivalence recommendations for Dexamethasone; Tobramycin (Suspension/Ophthalmic), the following studies are recommended.

❝

❝ Type of study: Bioequivalence study with pharmacokinetic (PK) endpoints

❝ Design: Single-dose, parallel design, in-vivo in aqueous humor

❝ Strength: 0.1%/0.3%

❝ Subjects: Patients undergoing indicated cataract surgery

OK I thought this was a question about a suspension product for which no specific guidance existed.
Since the design is given, what is your question?

Best regards,
EM.

Complete thread:

BE study requirements for Opthalmic and Otic suspensions scorp2011 2011-11-25 08:52
- BE study requirements for Opthalmic and Otic suspensions ElMaestro 2011-11-25 10:40
  - BE study requirements for Opthalmic and Otic suspensions scorp2011 2011-11-25 10:58
    - BE study requirements for Opthalmic and Otic suspensionsElMaestro 2011-11-25 12:27
      - BE study requirements for Opthalmic and Otic suspensions scorp2011 2011-12-07 07:27