Bioequivalence and Bioavailability Forum

Biowaiver for low-strength (<5%) [Regulatives / Guidelines]

posted by Melkor – Greece, 2014-01-20 14:59 (4540 d 21:57 ago) – Posting: # 12203
Views: 6,265

Dear all,

According to EMA's Bioequivalence Guideline (General Biowaiver Criteria), a BE study for a certain strength can be waived in the case (3rd requirement of the Guideline) i and ii or i and iii are fulfilled. Criteria i reads:

"i. The amount of the active substance is less than 5% of the tablet core weight."

My question is whether this is referred to the active substance in the base form or in a salt form. According to definitions, an active substance is the one that has the therapeutic effect (usually the base or an active metabolite) which most probably answers my question.

Any advice on this?

Thank you.

Complete thread:

• Biowaiver for low-strength (<5%)Melkor 2014-01-20 13:59 
  • API = salt? Helmut 2014-01-20 14:24
    • API = salt? Melkor 2014-01-20 15:28
      • 5 %: both formulations Ohlbe 2014-01-20 16:21
        • 5 %: both formulations Helmut 2014-01-20 17:04
          • 5 %: both formulations Ohlbe 2014-01-20 17:32
            • 5 %: both formulations Melkor 2014-01-22 12:34
            • Active moiety Helmut 2014-01-23 00:54
              • Change of API and fate of biostudy kumarnaidu 2014-06-27 10:54