Metrics challenges for monographs

The history of impact metrics as a field driven by the sciences presents real problems for Arts and Humanities scholars. Whereas scientists have long depended on journal articles as a primary mechanism for publishing findings, researchers in the Arts and Humanities tend to publish in a much wider range of formats. For many Arts and Humanities scholars, conference presentations, creative works, reports and scholarly monographs are legitimate, valuable and valued forms of publication. Bizarre as it may seem, even the best-established and most respected format for the publication of Humanities scholarship, the scholarly monograph, is often invisible within digital metrics landscapes. As a result, although some information about Arts and Humanities scholars may be captured by impact metrics, academics from these fields always appear to perform less well than colleagues in the Sciences when measured using tools designed for scientists.

Biowaiver monographs for immediate-release solid oral dosage forms: Stavudine

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing stavudine (d4T) are reviewed. According to Biopharmaceutics Classification System (BCS), d4T can be assigned to BCS class I. No problems with BE of IR d4T formulations containing different excipients and produced by different manufacturing methods have been reported and, hence, the risk of bioinequivalence caused by these factors appears to be low. Furthermore, d4T has a wide therapeutic index. It is concluded that a biowaiver is appropriate for IR solid oral dosage forms containing d4T as the single active pharmaceutical ingredient (API) provided that (a) the test product contains only excipients present in the IR d4T drug products that have been approved in a number of countries for the same dosage form, and (b) both test product and its comparator are either very rapidly dissolving or rapidly dissolving with similarity of dissolution profiles demonstrated at pH 1.2, 4.5, and 6.8. (c) 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:1016, 2012