heritage
☆    

India,
2018-05-05 06:25

Posting: # 18755
Views: 1,565
 

 Bioequivalence of IR vs MR tablet [Design Issues]

One drug has been approved as IR tablet given 100 mg bid (total dose 200 mg). We want to make one ER formulation of 230 mg which can be given once daily. I need help in following issues

1. What should be the design?
2. Which PK parameter I should be looking at?
3. Should I do fasting or fed study?
4. Should I targeting BE in Cmax or AUC?

Please give me some reading material or link to any post wherein this had been already discussed

Thanks in advance


Edit: Category changed; see also this post #1. [Helmut]
bebac_fan
☆    

US,
2018-05-05 17:08

@ heritage
Posting: # 18756
Views: 1,326
 

 Consider 505(b)(2) Pathway

I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA.

In this case, comparative efficacy, rather than BE, will be considered pivotal.
Obinoscopy
★    

Nigeria,
2018-05-15 19:04

@ bebac_fan
Posting: # 18764
Views: 1,060
 

 Pathway for Softgel vs Tablet Comparison

Dear bebac_fan,

» I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA.
»

I share the same view with you on this.

However I have a case where a BE study was conducted comparing Metronidazole tablet (Reference) with Metronidazole soft gel (test). Both were IR. Is this acceptable?

Regards,

Scopy
jag009
★★★

NJ,
2018-05-18 16:33

@ Obinoscopy
Posting: # 18786
Views: 966
 

 Pathway for Softgel vs Tablet Comparison

Hi,

» However I have a case where a BE study was conducted comparing Metronidazole tablet (Reference) with Metronidazole soft gel (test). Both were IR. Is this acceptable?

Have you read this guidance? FDA

John
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