Bioequivalence for different formulations of inhaled drugs poses special problems that require clinical studies in patients. 1 argue that these should contain multiple doses per formulation and derive a simple formula for the calculation of sample size for such studies.
SennS. Statistical Issues in Drug Development, 2nd ed., chapter 22. Statistics in Practice. New York: Wiley; 1997.
2.
UsmaniOSBiddiscombeMFBarnesPJ. Regional lung deposition and bronchodilator response as a function of β2-agonist particle size. Am J Respir Crit Care Med.2005; 172: 1497–1504.
3.
KällénA. A note on therapeutic equivalence and therapeutic ratio with applications to studies in respiratory diseases. Drug Inf J.2001; 35: 1495–1505.
4.
KällénALarssonP. Dose response studies: How do we make them conclusive?Stat Med.1999; 18: 629–641.
5.
KällénALarssonP. On the definition of therapeutic equivalence. Drug Inf J.2000; 34: 349–354.
6.
FDC Reports, The Pink Sheets.53(18):14–15 (May 6, 1991).