Bioequivalence and Bioavailability Forum • Test samples expired for FED study

Test samples expired for FED study [Regulatives / Guidelines]

posted by taiyab.jameel – India, 2020-03-05 10:02 (318 d 18:15 ago) – Posting: # 21205
Views: 4,563

Hello,

We have conducted Fasting BE study for Pantoprazole Sodium delayed release tablets from CRO.

As we are filing products in regulated market we have to performed Fed study as per EMEA & FDA guidelines.

Now problem is our Test samples are expired but RLD expiry renaming for next 8 months.

How can we conduct fed study. What are the challenges we can face after filing.

Complete thread:

Test samples expired for FED studytaiyab.jameel 2020-03-05 10:02 [Regulatives / Guidelines]
- Test samples expired for FED study jag009 2020-03-05 21:57
  - Test samples expired for FED study taiyab.jameel 2020-03-06 04:15
    - Different batches Helmut 2020-03-06 11:21
      - Different batches taiyab.jameel 2020-03-06 12:26
        
        Different batches Marcelo Davanco 2020-03-06 12:37
        
        Different batches wienui 2020-03-07 16:10
        
        The soft-spoken voice of reason Helmut 2020-03-07 22:04
        Different batches Marcelo Davanco 2020-03-08 00:32
        
        Different batches wienui 2020-03-08 10:19
- Test samples expired for FED study ElMaestro 2020-03-05 22:27
  - Test samples expired for FED study Dr_Dan 2020-03-11 11:39