Assessing completion reports for compliance with institutional ethics committee-approved protocols: An observational study

Gajbhiye, Snehalata; Jalgaonkar, Sharmila; Dabba, Sarita G; Surve, Shweta; Lad, Manasi S

doi:10.20529/ijme.2020.025

Cited by 4 publications

(1 citation statement)

References 6 publications

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“…Samples were precisely weighed on the aluminium pans and then tightly packed with aluminium lids. Thermo grams were collected in a liquid nitrogen atmosphere at a frequency in the range of 10°C/min above temperature ranging between 30-250° C 37 .…”

Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

Untitled

2022

IJPSR

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The goal of this study was to develop taste-masked orally disintegrating tablets of the bitter-tasting levocetirizine dihydrochloride (LCDH) to improve the accessibility and adherence of pediatric, elderly, non-cooperative and paraplegic patients. Methods: In the present study, orally disintegrating Levocetirizine dihydrochloride tablets were formulated by direct compression. Taste masking was achieved using a pH-independent polymeric dispersion of Surelease E-7-19040 in combination with Opadry YS-1-19025-A in different ratios. In-vivo taste evaluation was done to see if the tablets produced utilizing the direct compression approach were successfully disguised. Results: The present study investigated uncoated and coated drug substances and prepared tablets of coated LCDH for flow as well as compression behaviour, Fourier Transform Infrared absorption spectra, Differential scanning calorimetry, powder X-ray diffraction, scanning electron microscopy and in-vitro dissolution and disintegration properties. Conclusion: Using a combination of two polymeric dispersions "Sure lease E-1-19040" and "Opadry" coating for the delivery of LCDH, it was shown that a taste-masking evaluation could be performed to identify effective polymer-carriers for the LCDH. INTRODUCTION:Taste is one of the important quality attributes that govern the palatability of the formulation and, in turn acceptability by the patient. The bitter taste is one of the foremost challenges that formulators encounter while working with bitter-taste drug molecules.

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Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

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2022

IJPSR

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Identifying Strategies for Strengthening Behavioral and Social Science Research Study Conduct

Murphy,

Guetterman,

Haro

et al. 2024

Journal of Empirical Research on Human Research Ethics

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Behavioral and social science research (BSSR) studies are less stringently regulated compared to drug and device studies. At our university, internal quality assurance activities revealed BSSR studies have more, but similar, issues compared to other studies. However, most institutional resources are tailored to support drug and device research, leaving an evidence gap regarding effective strategies for fostering rigorous BSSR study conduct. Two campus units partnered to undertake a two-phase study. First, we characterized compliance issues based on BSSR study audit data. Second, we conducted interviews with behavioral researchers and others to discuss contributors to compliance issues and potential mitigating strategies. Through thematic analysis, we identified problems at that can be addressed at individual, study team, and university systems levels. Study results outline potential strategies to reduce compliance issues.

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Hurdles to Medical Research during Graduation and The Way Forward – A Graduate’s Perspective (Preprint)

Mulkalwar¹

2021

Preprint

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UNSTRUCTURED History is replete with examples of noteworthy contributions by medical students. However, uptake of undergraduate research opportunities in India is reported to be disappointing, and little is known about the hurdles faced by students in undertaking research activities. This article provides an insight into the scope, hurdles and possible solutions with respect to pursuing research projects by medical undergraduate students.

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Assessing completion reports for compliance with institutional ethics committee-approved protocols: An observational study

Abstract: Attitudes of physicians and public to pharmaceutical industry 'gifts' .

Cited by 4 publications

References 6 publications

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Identifying Strategies for Strengthening Behavioral and Social Science Research Study Conduct

Hurdles to Medical Research during Graduation and The Way Forward – A Graduate’s Perspective (Preprint)

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