Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.
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Biomedical subjects
Publications and source records attributed to W Adams.
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An intracisternal protein in the type II pneumocyte of the ferret, guinea pig, and mongrel dog was examined by light and electron microscopy and morphometry. The basic pattern of layering in this membrane-bound, ribosome-studded structure (cisternal body) was visualized in cross section as dense layers separated by approximately 0.1 micron with seven fine layers between. In all species the central fine band of the seven was occasionally more prominent than the other six. In the guinea pig the seven fine layers alternated in density from light to dark. The cisternal body of the dog was similar to that of the ferret, but was very much smaller and encountered infrequently. No function has been ascribed to this structure; however, its relation to lamellar bodies, the perinuclear membrane, and surfactant apoprotein is discussed.
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PURPOSE: The systemic concentration of dehydroepiandrosterone decreases with age in primates while in humans intraocular pressure (IOP) increases with aging. This study was designed to investigate if a relationship existed between dehydroepiandrosterone and IOP in pigmented rabbits. METHODS: Animals were treated unilaterally for 6 weeks with topical 3% dehydroepiandrosterone in 30% 2-hydroxypropyl-beta-cyclodextrin; the contralateral eye received vehicle alone. Drops were applied, and IOP measured, twice daily. RESULTS: Small, but statistically significant, drug-related effects were found. IOP was consistently higher in the afternoon; the afternoon minus morning difference in IOP, however, decreased with time. Topical, radioactive drug application indicated very low level penetration into aqueous humor, iris, corneal epithelium, the rest of the cornea, or bulbar conjunctiva. CONCLUSION: The small drug-related effects may be due, in large part, to poor intraocular drug penetration. The circadian rhythm of IOP appears to be time-dependent in chronic studies with a gradual loss of IOP difference between a.m. and p.m. readings.
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