Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules

This work describes the development and validation of a dissolution test for 60 mg of diltiazem hydrochloride in immediate release capsules. The best dissolution in vitro profile was achieved using potassium phosphate buffer at pH 6.8 as the dissolution medium and paddle as the apparatus at 50 rpm. The drug concentrations in the dissolution media were determined by UV spectrophotometry and HPLC and a statistical analysis revealed that there were significant differences between HPLC and spectrophotometry. This study illustrates the importance of an official method for the dissolution test, since there is no official monograph for diltiazem hydrochloride in capsules.

Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets

A simple, precise, specific, repeatable and discriminating dissolution test for primaquine (PQ) matrix tablets was developed and validated according to ICH and FDA guidelines. Two UV assaying methods were validated for determination of PQ released in 0.1 M hydrochloric acid and water media. Both methods were linear (R²>0.999), precise (R.S.D.<1.87%) and accurate (97.65-99.97%). Dissolution efficiency (69-88%) and equivalence of formulations (f2) was assessed in different media and apparatuses (basket/100 rpm and paddle/50 rpm) tested. Discriminating condition was 900 mL aqueous medium, basket at 100 rpm and sampling times at 1, 4 and 8 h. Repeatability (R.S.D.<2.71%) and intermediate precision (R.S.D.<2.06%) of dissolution method were satisfactory.

Validation of the Brazilian Children's Test of Pseudoword Repetition in Portuguese speakers aged 4 to 10 years

The phonological loop is a component of the working memory system specifically involved in the processing and manipulation of limited amounts of information of a sound-based phonological nature. Phonological memory can be assessed by the Children's Test of Nonword Repetition (CNRep) in English speakers but not in Portuguese speakers due to phonotactic differences between the two languages. The objectives of the present study were: 1) to develop the Brazilian Children's Test of Pseudoword Repetition (BCPR), a Portuguese version of the CNRep, and 2) to validate the BCPR by correlation with the Auditory Digit Span Test from the Stanford-Binet Intelligence Scale. The BCPR and Digit Span were assessed in 182 children aged 4-10 years, 84 from Minas Gerais State (42 from a rural region) and 98 from the city of São Paulo. There are subject age and word length effects causing repetition accuracy to decline as a function of the number of syllables of the pseudowords. Correlations between BCPR and Digit Span forward (r = 0.50; P <= 0.01) and backward (r = 0.43; P <= 0.01) were found, and partial correlation indicated that higher BCPR scores were associated with higher Digit Span scores. BCPR appears to depend more on schooling, while Digit Span was more related to development. The results demonstrate that the BCPR is a reliable measure of phonological working memory, similar to the CNRep.

Validation et conditionnement d'un test PAMPA amélioré pour l'évaluation de la perméabilité membranaire de médicaments.

Les tests PAMPA et les tests Caco-2 sont des essais in vitro de l’évaluation de la perméabilité intestinale des médicaments. Ils sont réalisés lors de la phase de découverte du médicament. Les tests PAMPA ne sont pas biologiquement représentatifs de la paroi intestinale, mais ils sont rapides et peu coûteux. Les tests Caco-2 nécessitent plus de 21 jours pour la culture cellulaire et des installations spécifiques sont requises. Ils sont constitués d’une monocouche d’entérocytes à confluence et donc plus biologiquement représentatifs. Il y a un besoin pour le développement d’un essai qui est biologiquement représentatif de la membrane intestinale humaine, rapide et peu coûteux. Le premier but de ce projet était de développer une méthode analytique qui permettrait l’évaluation simultanée de huit médicaments témoins utilisés pour la validation de l’essai de perméabilité. Le deuxième but de ce projet était donc d’améliorer la membrane des tests PAMPA pour proposer un nouveau test : le néoPAMPA. Contrairement au test PAMPA traditionnel, cette membrane est constituée de trois composantes : (1) un filtre poreux qui agit à titre de support, (2) un coussin polydopamine chargé négativement qui sert d’ancrage et qui assure la fluidité de la bicouche et (3) une bicouche lipidique formée par fusion de vésicules. Une méthode analytique HPLC-MS/MS a été validée selon les spécifications de la FDA et de la EMA. Cette méthode a permis de quantifier simultanément les huit médicaments standards utilisés pour le test néoPAMPA. Le test PAMPA traditionnel a été mis en place à titre d’essai control. Les coefficients de perméabilité mesurés pour les huit médicaments au travers de la membrane PAMPA comparaient favorablement aux résultats de la littérature. Les composantes de la membrane néoPAMPA ont été optimisées. Les conditions optimales retenues étaient les filtres de polycarbonate hydrophile ayant des pores de 15 nm, les plaques Costar 12 puits comme dispositif des tests de perméabilité, une bicouche lipidique composée de 70 % DOPC et de 30 % cholestérol cationique ainsi qu’une déposition des liposomes en présence de 150 mM NaCl suivi d’un équilibre d’1 h en présence d’une solution saturée en DOPC. Les stabilités de la cassette de médicaments et des liposomes sont insuffisantes pour le conditionnement commercial des membranes néoPAMPA. Les différentes optimisations réalisées ont permis d’améliorer la membrane néoPAMPA sans toutefois la rendre fonctionnelle. La membrane néoPAMPA n’est toujours pas en mesure de discriminer des molécules en fonction de leur perméabilité attendue.

Validation of the Spanish version of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Resumen tomado de la publicaci??n

Validation of the Rhode Island Test of Language Structure with orally educated hearing-impaired students

This paper examines the Rhode Island Test of Language Structures (RITLS) and its measurement of the comprehension of syntax, and the relationship of this comprehension to the use of syntax in the production of spoken English by orally educated hearing-impaired students.

The challenge of validation: assessing the performance of a test of productive vocabulary

This paper assesses the performance of a vocabulary test designed to measure second language productive vocabulary knowledge.The test, Lex30, uses a word association task to elicit vocabulary, and uses word frequency data to measure the vocabulary produced. Here we report firstly on the reliability of the test as measured by a test-retest study, a parallel test forms experiment and an internal consistency measure. We then investigate the construct validity of the test by looking at changes in test performance over time, analyses of correlations with scores on similar tests, and comparison of spoken and written test performance. Last, we examine the theoretical bases of the two main test components: eliciting vocabulary and measuring vocabulary. Interpretations of our findings are discussed in the context of test validation research literature. We conclude that the findings reported here present a robust argument for the validity of the test as a research tool, and encourage further investigation of its validity in an instructional context

Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Validation of a Leishmania infantum ELISA rapid test for serological diagnosis of Leishmania chagasi in dogs

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Validation of the lactate minimum test as a specific aerobic evaluation protocol for table tennis players

The purpose of this study was to validate the lactate minimum test as a specific aerobic evaluation protocol for table tennis players. Using the frequency of 72 balls·min-1 for 90 sec, an exercise-induced metabolic acidosis was determined in 8 male table tennis players. The evaluation protocol began with a frequency of 40 balls·min-1 followed by an increase of 8 balls·min-1 every 3 min until exhaustion. The mean values that corresponded to the subjects' lactate minimum (Lacmin) were equal to 53.1 ± 1.5 balls·min-1 [adjusted for the time test (Lacmin_time)] and 51.6 ± 1.6 balls·min-1 [adjusted for the frequency of balls (Lacmin_Freq)], which resulted in a high correlation between the two forms of adjustment (r = 0.96 and (P = 0.01). The mean maximum lactate steady state (MLSS) was 52.6 ± 1.6 balls·min-1. Pearson's correlations between Lacmin_time vs. MLSS and Lacmin_freq vs. MLSS were statistically significant (P = 0.03 and r = 0.86, P = 0.03 and r = 0.85, respectively). These findings indicate that the Lacmin test predicts MLSS. Therefore, it is an excellent method to obtain the athletes' anaerobic threshold. Also, there is the advantage that it can be performed in 1 day in the game area. However, the Lacmin value does not depend on the Lacpeak value.

Development and validation of dissolution test for fluconazole capsules by HPLC and derivative UV spectrophotometry

The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900 mL of HCl 0.1 M, 37 ± 0.5 °C using baskets with 50 rpm for 30 min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed.

[Field validation of a real-time PCR test for the detection of Mycoplasma hyopneumoniae in nasal swabs of live pigs]

Enzootic pneumonia (EP) of pigs, caused by Mycoplasma hyopneumoniae has been a notifiable disease in Switzerland since May 2003. The diagnosis of EP has been based on multiple methods, including clinical, bacteriological and epidemiological findings as well as pathological examination of lungs (mosaic diagnosis). With the recent development of a real-time PCR (rtPCR) assay with 2 target sequences a new detection method for M. hyopneumoniae became available. This assay was tested for its applicability to nasal swab material from live animals. Pigs from 74 herds (average 10 pigs per herd) were tested. Using the mosaic diagnosis, 22 herds were classified as EP positive and 52 as EP negative. From the 730 collected swab samples we were able to demonstrate that the rtPCR test was 100% specific. In cases of cough the sensitivity on herd level of the rtPCR is 100%. On single animal level and in herds without cough the sensitivity was lower. In such cases, only a positive result would be proof for an infection with M. hyopneumoniae. Our study shows that the rtPCR on nasal swabs from live pigs allows a fast and accurate diagnosis in cases of suspected EP.

Validation of a Dumbbell Body Sway Test in Olympic Air Pistol Shooting

We present and validate a test able to provide reliable body sway measurements in air pistol shooting, without the use of a gun. 46 senior male pistol shooters who participated in Spanish air pistol championships participated in the study. Body sway data of two static bipodal balance tests have been compared: during the first test, shooting was simulated by use of a dumbbell, while during the second test the shooters own pistol was used. Both tests were performed the day previous to the competition, during the official training time and at the training stands to simulate competition conditions. The participants performance was determined as the total score of 60 shots at competition. Apart from the commonly used variables that refer to movements of the shooters centre of pressure (COP), such as COP displacements on the X and Y axes, maximum and average COP velocities and total COP area, the present analysis also included variables that provide information regarding the axes of the COP ellipse (length and angle in respect to X). A strong statistically significant correlation between the two tests was found (with an interclass correlation varying between 0.59 and 0.92). A statistically significant inverse linear correlation was also found between performance and COP movements. The study concludes that dumbbell tests are perfectly valid for measuring body sway by simulating pistol shooting.