Bioequivalence and Bioavailability Forum

Dear Jagan,

you crossposted already at David’s PKPD-list. In case you didn’t receive my answer last Friday, see below:

---

The difference between FDA and EMA is that FDA has published – besides the general guidances – 822 product specific guidances. Your study design should be based on science first. Do you really think that EMA wants you to risk hypoglycemic episodes in your study, just because nothing specifically to prevent them is stated in the European BE guideline?
BTW, what do you think about following section of the GL (4.1.4 Study conduct, Standardisation):

In rare cases, the use of a concomitant medication is needed for all subjects for safety […] reasons.

Rose

is a rose
is a rose
is a rose (Gertrude Stein)

Guidelines

are guidelines
are guidelines (Henrike Potthast, German BfArM)

---