Abstract:
:A common but not necessarily logical requirement in drug development is that a 'limit of quantitation' be set for chemical assays and that observations that fall below the limit should not be treated as real data but should be labelled as below the limit and set aside for special treatment. We examine five of seven approaches to analysing such data considered by Beal in 2001, concentrating in particular on two: one that treats the data as a truncated sample and another that treats them as a censored sample. In fact, using a pattern-mixture framework, one can show that the former consists of using the conditional distribution of the 'acceptable values' and the latter adds the information from the marginal mixing distribution. We illustrate these approaches with a real example, concentrating in particular on the two likelihood-based methods, provide various formulae that may be used to compare these and other approaches, check these formulae using simulations and make some recommendations as to which approach one should use.
journal_name
Stat Medjournal_title
Statistics in medicineauthors
Senn S,Holford N,Hockey Hdoi
10.1002/sim.5515subject
Has Abstractpub_date
2012-12-30 00:00:00pages
4280-95issue
30eissn
0277-6715issn
1097-0258journal_volume
31pub_type
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