Bioequivalence and Bioavailability Forum

EMA: Sirolimus product-specific GL [Regulatives / Guidelines]

posted by luvblooms  – India, 2013-11-19 14:00 (4193 d 07:24 ago) – Posting: # 11912
Views: 28,995

Dear HS and All

❝ Sirolimus

❝ No strict dose-proportionality between 0.5 and 5 mg tablets.

❝ 0.5 and 5 mg tablets, 1 mg/ml solution (if similarity requirements not fulfilled). Single dose cross-overs in healthy subjects (fasting and fed state), parent in blood (achiral),

❝ AR 90.00–111.11% for AUC_t (NTID) and 80.00–125.00% for for C_max.

Have a small doubt that is there some typographic error or something in Sirolimus guidance?

If I am right, in EU Rapamune is available in following strengths (as per the SmPC approved/updated in Sep-13)

Rapamune^® 0.5 mg coated tablets
Rapamune^® 1 mg coated tablets
Rapamune^® 2 mg coated tablets
Rapamune^® 1 mg/ml oral solution

Now from where 5 mg strength came in picture?

Rapamune^® 5 mg Tablets are only approved in Canada (not in US- was there earlier but not discontinued or EU)?

What if one wants to develop only two strengths 1mg and 2 mg?

Am I missing something over here or getting too paranoid?

Complete thread:

• Bioequivalence Recommendations for Specific Pro­ducts cr.maroj 2013-09-19 11:00 [Regulatives / Guidelines] 
  • Bioequivalence Recommendations for Specific Pro­ducts Ohlbe 2013-09-19 11:45
    • EMA: Draft product-specific guidances ♬ Helmut 2013-11-15 15:45
      • EMA: Draft product-specific guidances ♬ luvblooms 2013-11-19 06:35
      • EMA: Capecitabine product-specific guidance ♬ mittyri 2013-12-10 15:33
        • EMA: Capecitabine product-specific guidance ♬ Helmut 2013-12-10 16:11
          • Russian GL 2013: harmonisation to EMA mittyri 2013-12-14 11:57
      • EMA: Draft product-specific guidances ♬ pash413 2013-12-18 12:35
        • EMA: Use of AUC72 not dependent on t½ Helmut 2013-12-18 14:35
      • End of consultation approaching‼ Helmut 2014-02-10 18:33
        • End of consultation approaching‼ Dr_Dan 2016-01-28 09:27
          • Guesstimates Helmut 2016-01-28 13:32
  • EMA: generally no product-specific GLs Helmut 2013-09-19 11:48
    • Thank you cr.maroj 2013-09-19 13:03
    • EMA: generally no product-specific GLs The Outlaw Torn 2013-09-20 07:52
      • EMA: parent whenever possible Helmut 2013-09-20 09:02
        • EMA: parent whenever possible cr.maroj 2013-09-20 10:14
          • EMA: parent whenever possible Helmut 2013-09-20 12:53
            • EMA: parent whenever possible Ohlbe 2013-09-20 13:52
              • EMA: parent whenever possible mittyri 2013-09-20 14:55
                • EMA vs. Russia Helmut 2013-09-20 19:21
                  • FDA: Prasugrel intuitivepharma 2013-12-20 07:36
                    • FDA: Prasugrel Helmut 2013-12-20 13:46
                      • FDA: Prasugrel intuitivepharma 2013-12-24 06:38
                        • FDA: Alternative approaches… Helmut 2013-12-24 14:15
                          • FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
                            • FDA: RTR Helmut 2013-12-26 14:35
                              • FDA: RTR intuitivepharma 2013-12-31 05:34
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                                • WayBack Machine Helmut 2015-07-23 16:58
                                  • WayBack Machine meghalvakil20 2015-07-23 17:03
                                    • Old stuff Helmut 2015-07-23 17:28
                • EMA: parent whenever possible ElMaestro 2013-09-20 19:35
                  • EMA: Sirolimus product-specific GLluvblooms 2013-11-19 13:00