Bioequivalence and Bioavailability Forum

Dear Roddy!

http://www.fda.gov/cder/guidance/5356fnl.pdf The general Guidance (2003) states for IR products:
'…, we recommend that where the focus is on release of the drug substance from the drug product into the systemic circulation, a single-dose, fasting study be performed.'

http://www.fda.gov/cder/guidance/5194fnl.pdf The Food Effect Guidance (2002) states for IR ANDAs:

'In addition to a BE study under fasting conditions, we recommend a BE study under fed conditions for all orally administered immediate-release drug products, with the following exceptions:

• When both test product and RLD are rapidly dissolving, have similar dissolution profiles, and contain a drug substance with high solubility and high permeability (BCS Class I) (see footnote 3), or
  
• When the DOSAGE AND ADMINISTRATION section of the RLD label states that the product should be taken only on an empty stomach, or
  
• When the RLD label does not make any statements about the effect of food on absorption or administration.'

Therefore unless you have a BCS Class I compound, IMHO you will have to perform both a fasting and a fed study.

Anyhow, if the food effect documented in the reference's SmPC is safety-related (i.e., AEs due to GI-disturbances), you may start an argument.

Remark: in such a case European Guidelines call only for a fed study.

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Edit: Links corrected for FDA’s new site. [Helmut]