AIBILI-Association for Innovation and Biomedical Research on Light and Image

Prospective randomized controlled trial comparing subthreshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema.

Figueira, J., Khan, J., Nunes, S., Sivaprasad, S., Rosa, A., Abreu, J., Cunha-Vaz, J., Chong, V.

Br. J. Ophthalmol. 2009 Oct;93(10):1341-4. Epub 2008 Dec. 3.

2008

The Accuracy and Clinical Application of Predictive Models for Primary Open-Angle Glaucoma in Ocular Hypertensive Individuals.

The Ocular Hypertension Treatment Study Group and the European Glaucoma Prevention Study Group

Ophthalmology 2008 Nov; 115(11):2030-2036.

2008

Limbal transplantation: multicenter retrospective case séries analysis.

Torres, J., Fernández, I., Quadrado, MJ., Murta, J., Herreras, J., Rodrigues-Ares, MT., Benítez-delCastillo, JM., Alio, J., Muñoz, MF., Calonge, M.

Arch. Soc. Esp. Oftalmol. 2008 Jul; 83(7):417-22.

2008

Treatment of neovascular age-related macular degeneration in patients with diabetes.

Cumings, M., Cunha-Vaz, J.

Clinical Ophthalmol. 2008:2(2):1-7.

2008

Short-term efficacy and safety of intravitreal ranibizumab for myopic choroidal neovascularization.

Silva, R., Ruiz-Moreno, J., Nascimento, J., Carneiro, A., Rosa, P., Barbosa, A., Carvalheira, F., Faria de Abreu, J., Cunha-Vaz, J.

Retina, 2008 Oct; 28(8): 117-23.

2008

Laboratory diagnosis of endophthalmitis: comparison of microbiology and molecular methods in the European Society of Cataract & Refractive Surgeons multicenter study and susceptibility testing.

Seal, D., Reischl, U., Behr, A., Ferrer, C., Alió, J., Koerner, RJ., Barry, P.,; ESCRS Endophthalmitis Study Group

J. Cataract Refract Surg. 2008 Sep; 34(9):1439-50.

2008

Retinal and cortical patterns of spatial anisotropy in contrast sensitivity tasks.

Silva, M.F., Maia-Lopes, S., Mateus, C., Guerreiro, M., Sampaio, J., Faria, P., Castelo-Branco, M.

Vision Res. 2008 Jan; 48(1):127-35.

2008

Evidence of widespread retinal dysfunction in patients with stargardt disease and morphologically unaffected carrier relatives.

Maia-Lopes, S., Silva, E.D., Silva, M.F., Reis, A., Faria, P., Castelo-Branco, M.

Invest. Ophthalmol. Vis. Sci. 2008 Mar; 49(3):1191-9.

2008

Effect of nebicapone on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects.

Luis Almeida, Amílcar Falcão, Manuel Vaz-da-Silva, Teresa Nunes, Ana-Teresa Santos, José-Francisco Rocha, Carla Neta, Tice Macedo, C. Fontes-Ribeiro, P. Soares-da-Silva

Abstract

Objective Nebicapone is a new catechol-O-methyltransferase inhibitor. In vitro, nebicapone has showed an inhibitory effect upon CYP2C9, which is responsible for the metabolism of S-warfarin. The objective of this study was to investigate the effect of nebicapone on warfarin pharmacokinetics and pharmacodynamics in healthy subjects.

Methods Single-centre, open-label, randomised, two-period crossover study in 16 healthy volunteers. In one period, subjects received nebicapone 200 mg thrice daily for 9 days and a racemic warfarin 25-mg single dose concomitantly with the nebicapone morning dose on day 4 (test). In the other period, subjects received a racemic warfarin 25-mg single dose alone (reference). The treatment periods were separated by a washout of 14 days.

Results For R-warfarin, mean ± SD C_max was 1,619 ± 284 ng/mL for test and 1,649 ± 357 ng/mL for reference, while AUC_0-t was 92,796 ± 18,976 ng·h/mL (test) and 73,597 ± 11,363 ng·h/mL (reference). The R-warfarin test-to-reference geometric mean ratio (GMR) and 90% confidence interval (90%CI) were 0.973 (0.878–1.077) for C_max and 1.247 (1.170–1.327) for AUC_0-t. For S-warfarin, mean ± SD C_max was 1,644 ± 331 ng/mL for test and 1,739 ± 392 ng/mL for reference, while AUC_0-t was 66,627 ± 41,199 ng·h/mL (test) and 70,178 ± 42,560 ng·h/mL (reference). The S-warfarin test-to-reference GMR and 90%CI were 0.932 (0.845–1.028) for C_max and 0.914 (0.875–0.954) for AUC_0-t. No differences were found for the pharmacodynamic parameter (INR).

Conclusion Nebicapone showed no significant effect on S-warfarin pharmacokinetics or on the coagulation endpoint (INR). A mild inhibition of the R-warfarin metabolism was found but is unlikely to be of clinical relevance.

European Journal of Clinical Pharmacology, 2008 Oct; 64 (10): 961-966.

2008
http://www.springerlink.com/content/m3617087h1347604/?p=cbf93c588e5a491e9c51cd20dc82f48d&pi=0

Dosage form proportionality and food-effect of the final tablet formulation of eslicarbazepine acetate in healthy volunteers

Carlos Fontes-Ribeiro, Tice Macedo, Teresa Nunes, Carla Neta, Teófilo Vasconcelos, Rui Cerdeira, Ricardo Lima, José-Francisco Rocha, Amílcar Falcão, Luís Almeida, Patrício Soares-da-Silva

Abstract:
Objective: To investigate the dosage form proportionality and food effect of the final tablet formulation of eslicarbazepine acetate (ESL) in healthy volunteers.

Methods: This was a randomized, three-way crossover, single-centre study in 18 healthy volunteers. Subjects received a single dose of oral ESL 800 mg following a standard meal in one period, and following 10 hours of fasting in two separate periods (in the form of one 800 mg tablet [reference] or two 400 mg tablets [test]). The statistical method was based upon the 90% confidence interval (CI) of maximum observed plasma drug concentration (Cmax), area under the plasma concentration time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the lower limit of quantification (AUCt) and AUC from time zero to infinity (AUC[infinity]) geometric means ratios (GMRs) of BIA 2-005, the enantiomeric mixture of the ESL active metabolite eslicarbazepine and its enantiomer R-licarbazepine. Bioequivalence was assumed when the 90% CI of the test/reference GMR fell within the bioequivalence acceptance interval (80.00, 125.00).

Results: Following a single dose of ESL 800 mg in the forms of two 400 mg tablets and one 800 mg tablet, the test/reference GMR (%) and 90% CI for Cmax, AUCt and AUC[infinity] were 100.78% (93.91, 108.16), 100.37% (97.82, 102.99) and 100.48% (97.91, 103.13), respectively. Following administration of one 800 mg tablet in fed (test) and fasting (reference) conditions, the test/reference GMR and 90% CI for Cmax, AUCt and AUC[infinity] were 100.96% (94.08, 108.35), 96.79% (94.34, 99.32) and 96.75% (94.27, 99.29), respectively. Treatments were well tolerated.

Conclusions: The bioequivalence criteria between the ESL 400 mg and 800 mg tablets were met and dosage form proportionality was demonstrated. The presence of food had no influence on ESL pharmacokinetics, indicating that ESL can be administered without regard to meals with no significant effects on drug disposition or extent of systemic exposure.

Drugs in R&D 2008; 9 (6): 447-454.

2008