Bioequivalence and Bioavailability Forum

Phaneendra.K ☆ 2011-05-11 10:56 (5526 d 06:22 ago) Posting: # 7001 Views: 3,337	BE study for modified release dosage forms [Design Issues] Post reply
	Hi, If a drug X of the innovator has got the formulation of immediate release oral tablets, and, a modified release tablet of the same, eg. extended release, has been developed, then how to conduct the BE study. (Will it be acceptible?) Does it get the generic approval? — Thanks and Regards, PK

Helmut ★★★ Vienna, Austria, 2011-05-11 13:25 (5526 d 03:53 ago) @ Phaneendra.K Posting: # 7005 Views: 2,661	BE study for modified release dosage forms Post reply
	Dear Phani! See e.g., Appendix 1 to the EU-GL. Generally you have to perform a clinical study also (Section 4.2). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes

BE study for modified release dosage forms [Design Issues]