Bioequivalence and Bioavailability Forum

Priyanka_S ☆ 2010-05-18 10:14 (5532 d 04:22 ago) Posting: # 5342 Views: 5,676	Bioequivalence for IR and MR formulations [PK / PD] Post reply
	Dear HS, We are planning a combination BE study in which one drug, both Test and Reference are Immediate Release formulations and another drug, Test is Modified release formulation and Reference is Immediate release formulation. Is it acceptable to show bioequivalence for IR and MR formulations? Kindly suggest me. Edit: Category changed. [Helmut] — Best Regards Priyanka S

Helmut
★★★

Vienna, Austria,
2010-05-18 18:18
(5531 d 20:18 ago)

@ Priyanka_S
Posting: # 5350
Views: 4,358

IR and MR # BE

Post reply

❝ Dear HS,

^^ ... and all the others. ;-)

❝ Is it acceptable to show bioequivalence for IR and MR formulations?

BE for drug 1 (IR requirements applicable), comparative BA for drug 2. You will never get a similar rate of absorption for drug 2 (unless your formulation is not working as expected). Maybe you get a similar extent (AUC) - but even this not guaranteed.

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Bioequivalence for IR and MR formulations [PK / PD]

IR and MR # BE