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The FDA Food-Effect Bioavailability and Fed Bioequivalence Guidance for
Industry (Section V. Data Analysis and Labeling) states that lag time
(Tlag) for modified-release products, if present, should be presented.
The guidance is vague about this measurement, and the data analysis
that is needed. Which method should be used to identify Tlag, and what
type of statistics are necessary, if at all?
Matthew Wasserman, B. Sc. Pharm, M. Sc.
Associate Pharmacokineticist, Biometrics
Apotex Research Inc. - Biomedical Division
440 Garyray Drive, Toronto,
Ontario, Canada M9L 1P7
Telephone: (416)749-9300 Ext. 8163
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