Bias in Sunscreen SPF Testing: A Review of Published Data.

Subversion bias, a type of selection bias, through manipulation of subject recruitment compromises data validity. This study explores the possibility of subversion bias in sunscreen sun protection factor (SPF) testing. It has been established that subjects with lower minimal erythemal dose (MED) values exhibit higher sunscreen SPF values.

Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps.

To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 15197:2013 criteria. Clinical trial registered at ClinicalTrials.

Disparate SPF Testing Methodologies Generate Similar SPFs. II. Analysis of P2 Standard Control SPF Data.

In the original scientific publication evaluating sunscreen methodologies, Garzarella and Caswell showed there to be no clinically significant or statistically significant difference in the average Sun Protection Factor (SPF) of a sunscreen formulation between any of three methodologies, Food and Drug Administration (FDA) Final Monograph, Australia/New Zealand, and European Cosmetics Association (COLIPA) International, suggesting that any differences in methodology were insignificant in the resulting SPF determined. These three major older methodologies have coalesced into two methodologies, 2011 FDA-Final Rule and ISO 24444, so that current sunscreen SPF testing is mostly 2011 FDA-Final Rule and ISO 24444. Another approach to evaluating the impact of methodological differences in sunscreen testing is to compare data on a control standard or reference sunscreen.

Non-comedogenic and non-acnegenic claim substantiation.

There are currently two methods to evaluate comedogenecity. One is the inexpensive human model developed by Mills and Kligman and modified by others. The second is the more costly human clinical trial, which is the gold standard for comedogenesis and to which the human model is compared.

Choosing an expected sun protection factor value.

Sun protection factor, SPF, is a measure of the efficacy of a topical sunscreen product; the higher the SPF, the greater the blockage of ultraviolet-induced erythema. While there are several methods to determine SPF, the Food and Drug Administration (FDA) methods are unique. The FDA methods define the label SPF value as the largest whole integer after subtracting an "A" value from the mean SPF.

Accuracy and user performance evaluation of a blood glucose monitoring system.

Background: The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies.

Materials And Methods: In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria.

Disparate SPF testing methodologies generate similar SPFs.

Regulatory agencies throughout the world have developed exclusive methodologies for assessing and classifying sunscreen product efficacy in their respective markets. Three prevalent methods, the Food and Drug Administration-Final Monograph (FDA-FM) method, the Australia/New Zealand (Aus/NZ) method, and the COLIPA International (International) method, contain procedural and statistical dissimilarities with undefined significance. The objective of our clinical trials was to evaluate the influence of these disparities on sun protection factor (SPF) values.

Interoperability of 300 watt and 150 watt xenon arc solar simulators in sun protection factor and in UVA protection factor clinical testing.

Background: The purpose of these clinical trials was to determine if 300 W and 150 W xenon arc solar simulators (SSs) deliver the same sun protection factor (SPF) and UVA protection factor (PFA).

Methods: First, the SPF of the P7 control standard and of the P2 control standard was determined, testing 20 subjects using the method described in the Food and Drug Administration (FDA) Final Monograph and using 150 W and 300 W SSs. In the second clinical trial, the PFA of the Japanese Cosmetic Industry Association (JCIA) control standard and of the P2 control standard was determined, testing 10 subjects using the method described in the JCIA Technical Bulletin and using 150 W and 300 W SSs.

Sand resistance of sunscreens.

Like water resistance in sunscreens, sand resistance in sunscreens is the ability of the sunscreen to retain its effectiveness while undergoing sand treatment. The influence of the type of sand on the sand resistance of sunscreens has not been described. The sand resistance of a control standard sunscreen, P2, and data on three grades of Quickrete commercial grade sand, #1961, #1962, and #1152, are described.

Water immersion does not alter the minimal erythema dose.

To determine the water resistance of a sunscreen, the COLIPA method requires the determination of two minimal erythema doses (MEDs): a static MED (MED(US)) and a wet MED (MED(UW)) (1). The MED(US) is used in calculating the static SPF; the MED(UW) is used in calculating the SPF after water immersion. Herein, we report that in the 107 subjects examined, the mean MED(US) (21.

Serum electrolyte shifts following administration of sodium phosphates enema.

The misuse of sodium phosphates enemas has resulted in reports of potentially severe metabolic and hemodynamic disturbances. Despite their long availability, these products have not been fully characterized pharmacokinetically. This trial sought to evaluate changes in the metabolic and hemodynamic parameters following the administration of one of two standard sodium phosphates enemas.

The time course and effect on serum electrolytes of oral sodium phosphates solution in healthy male and female volunteers.

Background: Although oral sodium phosphates solution is used extensively for bowel preparation, the pharmacokinetic profile of 2 x 45 mL oral sodium phosphates solution has not been reported.

Objectives: The primary objective of this study was to evaluate the time course and degree of electrolyte shifts in two age groups and two gender groups following administration of oral sodium phosphates solution. Secondary objectives included evaluation of electrocardiograms, postural blood pressure, standard serum chemistry and hematology panels, and adverse experiences.

Comparison of the moisturization efficacy of two vaginal moisturizers: Pectin versus polycarbophil technologies.

This study was designed to compare the vaginal deposition and moisturization of two vaginal moisturizers, Summer's Eve (SE), based on pectin, and Replens (Rp), based on polycarbophil, in a double-blind crossover study design. Fifty-one female patients were each randomly assigned to one of two treatment groups. After a one-week washout period, the products were used for two weeks.