Bioequivalence and Bioavailability Forum

rohitkachhadiya ☆ Gujarat, 2011-12-13 14:17 (5308 d 16:45 ago) Posting: # 7775 Views: 3,920	BE study for different strength of test and reference [Regulatives / Guidelines] Post reply
	Dear All, Kindly suggest me for ANVISA requirement/other regulatory requirement for below mentioned case. Test product strength is 750mg and innovator available is of 250mg. Can we do the BE study of *750mg test (1 unit of test) vs. 3250mg innovator (3 unit of reference)**. Regards Rohit

kaushik089 ★ India, 2012-01-02 10:19 (5288 d 20:42 ago) @ rohitkachhadiya Posting: # 7846 Views: 3,219	BE study for different strength of test and reference Post reply
	hello rohit, please mention whether it is an immediate release or modified release dosage? as per my knowledge we consider only IR as 250mg x 3 tab for compensating 750 mg dosage

Jaime_R ★★ Barcelona, 2012-01-02 14:22 (5288 d 16:39 ago) @ kaushik089 Posting: # 7848 Views: 3,193	IR only?! Post reply
	Hi kaushik089! ❝ ... we consider only IR as 250mg x 3 tab for compensating 750 mg dosage Why? Justification, references? — Regards, Jaime

Helmut
★★★

Vienna, Austria,
2012-01-02 17:02
(5288 d 14:00 ago)

@ kaushik089
Posting: # 7850
Views: 3,145

BE study for different strength of test and reference

Post reply

Dear Kaushik!

Agree with Jaime's post. We had never any problems with MR formulations. Of course the reference has to be approved for a o.a.d. regimen exceeding its highest strength.

Highest strength of the reference <750 mg, approved for ≥750 mg o.a.d.
Highest strength of the reference <750 mg, not approved for ≥750 mg o.a.d.
Clinical study required (not a generic anymore; in EMA’s terms a ‘hybrid application’). Whether or not a 750 vs. 3×250 study is acceptable depends on the safety profile of the drug (see the IR guideline: ‘The selected dose may be higher than the highest therapeutic dose provided that this single dose is well tolerated in healthy volunteers and that there are no absorption or solubility limitations at this dose.’) Go for a scientific advice.

ANVISA:

(as usual)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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BE study for different strength of test and reference [Regulatives / Guidelines]

BE study for different strength of test and reference

IR only?!

BE study for different strength of test and reference