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Introduction: Although generic drugs constitute approximately 88% of drugs prescribed in the US, there are no reliable methods to identify generic drugs in the US FDA Adverse Event Reporting System (FAERS).Objective: The aim of this study was to develop an algorithm for identifying generic drugs in the FAERS.Data Source: We used 1237 adverse event reports for tamsulosin, levothyroxine, and amphetamine/dextroamphetamine from the publicly available FAERS from 2011-2013, and 277 source case narratives obtained from the FDA.Methods: Two reviewers independently and in duplicate used a three-item algorithm including the following criteria: manufacturer name, New Drug Application (NDA) number/abbreviated NDA (ANDA), and specific use of the term 'generic' or 'brand' to classify the focal drug of each case report as definitely generic (two of three criteria), probably generic (one of three criteria), brand, and cannot be assessed. Inter-rater reliability was estimated using kappa coefficients, and internal consistency was estimated using Cronbach's alpha. We compared the classification of the drugs as generic versus non-generic in publicly available FAERS compared with the original case reports (reference).Results: The focal drug was classified as generic (definite or probable) in 15.8% (39/234), 9% (67/742), and 16.7% (42/261) of tamsulosin, levothyroxine and amphetamine/dextroamphetamine cases, respectively (overall kappa 0.89, 95% confidence interval 0.85-0.93), while 37% of reports could not be classified due to incomplete information. Among the drugs classified as generics using the publicly available FAERS, we categorized 95.3% as generic drugs using the original case reports. Among those drugs that did not meet the algorithm-based definition of generic in the publicly available data, 20.9% were reclassified as generics using the original case reports.Conclusions: The algorithm demonstrated high inter-rater reliability with moderate internal consistency for identifying generic drugs in the FAERS, in our sample. Future efforts should focus on improving the reliability and validity of identifying generics through improving the completeness of reporting in the FAERS. [ABSTRACT FROM AUTHOR]

Purpose: We aimed to describe a new technique and analyse the early outcomes of augmenting the canine tooth using a mandibular bone graft in an attempt to delay or retard the process of laminar resorption following the modified osteo odonto keratoprosthesis (MOOKP) procedure. Design: This was a retrospective case series. Patients and methods: Eyes that underwent the bone augmentation procedure between December 2012 and February 2014 were retrospectively analysed. The procedure, performed by the oromaxillofacial surgeon, involved securing a mandibular bone graft beneath the periosteum on the labial aspect of the canine tooth chosen to be harvested for the MOOKP procedure. This procedure was performed simultaneously with the Stage 1 A of the MOOKP. Three months later, the tooth was harvested and fashioned into the osteo-odonto alveolar lamina similar to the method described in the Rome-Vienna Protocol. Results: The bone augmentation procedure was performed in 11 eyes (five SJS/ six chemical injuries). The mean follow-up after Stage 2 of MOOKP procedure in these eyes was 7.45 months (2 to 20 months). Complications noted were peripheral laminar exposure (three eyes-SJS) and bone graft exposure and necrosis in the mouth (nine-SJS). No evidence of clinical laminar resorption was noted in any of the eyes. Conclusion: Laminar resorption in MOOKP can lead to vision and globe threatening complications due to the consequent cylinder instability and chances of extrusion. Augmenting the bone on the labial aspect of the canine tooth might have a role to play in delaying or preventing laminar resorption. [ABSTRACT FROM AUTHOR]

Purpose: To describe a new technique and analyze the outcome of procedures performed for anatomic and functional rehabilitation in eyes with lamina resorption following the modified osteo-odonto keratoprosthesis (MOOKP) procedure. Design: Retrospective case series. Patients & methods: Eighteen eyes were noted to have lamina resorption of the 85 eyes that underwent the MOOKP surgery over the last 10 years. Further intervention to salvage the globe, and therefore the visual potential, was possible in only 11 eyes, of which two are yet to undergo further intervention. Two patients who had undergone the procedure elsewhere also presented to our centre with evidence of resorption. In all, 11 eyes (nine operated at our centre, two operated elsewhere) were included in this study. Bone morphogenetic protein (BMP) was used alone or along with mandibular cancellous bone within the fibrovascular capsule of the osteo-odonto alveolar lamina, in an effort to prevent further resorption and promote bone generation in areas of resorption in ten eyes. In three of these eyes, there was a continued progression of resorption requiring lamina removal. In these three eyes and another eye with extrusion of the cylinder from the eye, the Lucia Type 2 keratoprosthesis was performed for visual rehabilitation (four eyes). Results: The BMP procedure was performed in ten eyes. Continued resorption with need for further rehabilitative surgery in the form of Lucia Type 2 Kpro was required in three of these eyes. Of the four patients who had the Lucia Type 2 Kpro, visual acuity improved to better than 20/200 in three eyes over a mean follow-up period of 3 months. Of the remaining seven eyes that had the BMP procedure performed, all have remained stable with respect to anatomic integrity of the lamina and globe, with maintenance of or improvement in pre BMP visual acuity over a mean follow-up of 9.2 months. No other complications of the procedure were noted. Conclusion: Resorption of the lamina in MOOKP can be addressed by reinforcing the same with BMP in eyes where the cylinder mobility is not significant, as a means to prolong the longevity of the existing lamina. The Lucia Type 2 Kpro might also have a role to play in the functional rehabilitation of eyes with severe lamina resorption or cylinder extrusion if preparation of a new lamina cannot be performed for various reasons. [ABSTRACT FROM AUTHOR]

Background: Stevens Johnson Syndrome (SJS) can lead to end stage corneal blindness. This study describes the comprehensive treatment measures and their outcomes in the management of ocular sequelae and complications of SJS. Methods: Four hundred sixty-four eyes of 232 patients of SJS who underwent surgical intervention (punctal cautery, mucus membrane grafting for lid margin keratinisation, fornix reconstructive procedures, tectonic procedures, keratoplasty and keratoprosthesis) were studied. It was a non-comparative, retrospective, interventional case series. The primary outcome was the change in the best corrected visual acuity (BCVA). Secondary outcome measures included an improvement in the ocular surface status as indicated by corneal epithelial fluorescein staining and Schirmer's I strip wetting. Results: The BCVA and the ocular surface status improved and/or stabilized in > 70 % of eyes following punctal cautery ( n = 160) and > 80 % of eyes following lid margin mucus membrane grafting ( n = 238). BCVA improved in 50 % of eyes following fornix reconstructive procedures ( n = 24) with COMET ( n = 6), in 63.9 % eyes with the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) lens ( n = 36), in 81.8 % of eyes after cataract surgery ( n = 22). A BCVA of ≥20/200 was achieved in 72.34 % of eyes following keratoprostheses procedures ( n = 47). The mean duration of follow up was 53.3 ± 15.2 months. Conclusion: The ocular sequelae of Stevens Johnson Syndrome can be blinding. They need to be identified and addressed early to retard the continued deterioration of the ocular surface. Our study aims to highlight the problem as well as the importance of comprehensive measures in the management of this potentially blinding disorder. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the outcome (functional and anatomic) of eyes that underwent tenonplasty as the primary globe-saving procedure in severe ocular chemical injuries (grade V-VI Dua's classification). Methods: The records of patients who underwent tenonplasty for associated scleral ischemia in severe chemical burns in our institute between October 2005 and June 2011 were analyzed retrospectively. Out of 31 eyes that underwent tenonplasty, 21 belonged to grade V and VI of Dua's classification with diffuse scleral ischemia for which a four-quadrant tenonplasty was performed and only these 21 eyes were included for further analysis. The time to presentation following chemical injury, the need for revision surgeries, the time to complete epithelization, the procedures performed for ocular surface reconstruction and for visual rehabilitation and their outcome, both functional and anatomic, were analyzed. Results: Of the 21 eyes of 13 patients, four were unilateral and nine were bilateral cases of chemical injury. The mean time to presentation following chemical injury was 14.61 days. Tenonplasty with amniotic membrane transplantation (AMT) was performed as the primary surgery. Revision tenonplasty was required in six eyes (seven procedures), the mean time to complete epithelization of the ocular surface was 5.4 ± 4.03 months. Of the 21 eyes, three lost perception of light following phthisis, evisceration for corneal infection, and uncontrolled glaucoma. Eighteen of 21 eyes were salvaged anatomically, of which ten eyes of 13 patients underwent surgery for visual rehabilitation. Among the unilateral cases, two eyes underwent ex vivo limbal stem cell transplant (LSCT) with or without keratoplasty for further visual rehabilitation. Among the patients with bilateral burns, visual rehabilitative procedure was performed in only one eye. Modified osteo-odonto-keratoprosthesis (MOOKP) was performed in five eyes, Boston type 1 keratoprosthesis in two eyes, and penetrating keratoplasty with keratolimbal allograft with systemic immunosuppression in one eye. One patient with bilateral injury is awaiting Boston keratoprosthesis type 1 for one eye. Of these eight eyes (bilateral injuries), all achieved a BCVA of 20/200 or better over a mean follow-up period of 27.37 ± 14.5 months following visual rehabilitative procedure. Conclusions: Tenonplasty has a globe-saving role in eyes with severe chemical injuries with associated scleral ischemia, by accelerating the healing process. Further on, these eyes can undergo visual rehabilitative procedures and our results highlight the feasibility of achieving a good functional outcome following anatomical stability. The role of tenonplasty to salvage the eye in the initial management of chemical injury, the need for multiple surgeries, close follow-up, and monitoring of intraocular pressure prior to and after procedures for visual rehabilitation cannot be underemphasized. [ABSTRACT FROM AUTHOR]

Quantitative Structure Activity Relationship correlating the antitubercular and antibacterial ( Staphylococcus aureus and Escherichia coli) activities with the structural descriptors of reported naphthyridine derivatives was developed. The data were divided into training and test sets. The former was used to develop the regression model and the latter was used to examine the predictive capability of these models. The statistical measures such as squared correlation coefficient ( r = 0.79-0.84), adjusted squared correlation coefficient ( r = 0.78-0.83) F-ratio (26.85-67.16), and cross-validation ( q = 0.74-0.79) were found to be satisfactory for all activities and the predictions were within the 99% confidence level. The models contained atom type, thermodynamic, structural, and electrotopological descriptors which emphasized the importance of the size, shape, and the lipophilicity of the molecule. [ABSTRACT FROM AUTHOR]

It has been predicted that nocodazole-inhibited cells are not synchronized because nocodazole-arrested cells with a G2-phase amount of DNA would not have a narrow cell-size range reflecting the cell size of some specific, presumably G2-phase, cell-cycle age. Size measurements of nocodazole-inhibited cells now fully confirm this prediction. Further, release from nocodazole inhibition does not produce cells that move through the cell cycle mimicking the passage of normal unperturbed cells through the cell cycle. Nocodazole, an archetypal whole-culture synchronization method, can inhibit growth to produce cells with a G2-phase amount of DNA, but such cells are not synchronized. Cells produced by a selective (i.e., non-whole-culture) method not only have a specific DNA content, but also have a narrow size distribution. The current view of cell-cycle control that is based on methods that are not suitable for cell-cycle analysis must therefore be reconsidered when results are based on whole-culture synchronization. [ABSTRACT FROM AUTHOR]