A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021

Jinja, Bhumi K.; Vyas, Amit Kumar J.; Patel, Nilesh K.; Patel, Ashok B.; Sheth, Devang; Shah, Sunny

doi:10.52711/2231-5691.2022.00048

Cited by 4 publications

(4 citation statements)

References 16 publications

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“…Only few dental studies have evaluated the quality of EDR data. 5 6 8 12 20 21 22 23 For example, Patel et al compared the self-reported cardiovascular disease (CVD) information with dental patients' medical records. They found low to no agreement and concluded that self-reported CVD information in the EDR may not be reliable research sources compared with electronic medical records.…”

Section: Discussionmentioning

confidence: 99%

“…EDR data also provide longitudinal patient care information for periodontal disease (PD) research. 12 13 PD is one of the most prevalent dental diseases which may cause tooth loss and poor quality of life if left untreated. 14 15 The prevalence of PD is high worldwide.…”

Section: Background and Significancementioning

confidence: 99%

“…14 18 Further research is needed to advance our knowledge of these diseases, including information about their prevalence, incidence and progression in various populations, etiologic factors among vulnerable groups, and long-term efficacy of various treatment regimens and in developing prediction models to identify high-risk patients, with the ability to provide up-to-date real-world information. 13…”

Section: Background and Significancementioning

confidence: 99%

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Developing Automated Computer Algorithms to Phenotype Periodontal Disease Diagnoses in Electronic Dental Records

et al. 2022

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Objective Our objective was to phenotype periodontal disease (PD) diagnoses from three different sections (diagnosis codes, clinical notes, and periodontal charting) of the electronic dental records (EDR) by developing two automated computer algorithms. Methods We conducted a retrospective study using EDR data of patients (n = 27,138) who received care at Temple University Maurice H. Kornberg School of Dentistry from January 1, 2017 to August 31, 2021. We determined the completeness of patient demographics, periodontal charting, and PD diagnoses information in the EDR. Next, we developed two automated computer algorithms to automatically diagnose patients' PD statuses from clinical notes and periodontal charting data. Last, we phenotyped PD diagnoses using automated computer algorithms and reported the improved completeness of diagnosis. Results The completeness of PD diagnosis from the EDR was as follows: periodontal diagnosis codes 36% (n = 9,834), diagnoses in clinical notes 18% (n = 4,867), and charting information 80% (n = 21,710). After phenotyping, the completeness of PD diagnoses improved to 100%. Eleven percent of patients had healthy periodontium, 43% were with gingivitis, 3% with stage I, 36% with stage II, and 7% with stage III/IV periodontitis. Conclusions We successfully developed, tested, and deployed two automated algorithms on big EDR datasets to improve the completeness of PD diagnoses. After phenotyping, EDR provided 100% completeness of PD diagnoses of 27,138 unique patients for research purposes. This approach is recommended for use in other large databases for the evaluation of their EDR data quality and for phenotyping PD diagnoses and other relevant variables.

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Section: Discussionmentioning

confidence: 99%

Section: Background and Significancementioning

confidence: 99%

Section: Background and Significancementioning

confidence: 99%

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Developing Automated Computer Algorithms to Phenotype Periodontal Disease Diagnoses in Electronic Dental Records

et al. 2022

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“…It is commonly known as the 'spade flower' or 'pink ladies slipper' [26]. It grows mainly in the warmer parts of India [27] and is also found distributed in the subtropical and tropical regions of the world [28] Traditionally this herb is used to treat both simple and complicated diseases and disorders [29] such as urinary infections, diarrhea and leucorrhoea. The phytochemical screening of Hybanthus enneaspermus has interpreted the presence of different bioactive compounds, namely alkaloids, flavonoids, phenols, tannins, sterols, nitro compounds and amines [30,31].…”

Section: Introductionmentioning

confidence: 99%

Synthesis, Characterisation, and in Vitro Biocompatibility Studies of Selenium Nanoparticles Synthesized using Hybanthus Enneaspermus Plant Extract for Potential Biomedical Applications

Priya Veeraraghavan,

Binithadas Segin Chandran,

Priya Manivannan

et al. 2023

TIJPH

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Hybanthus enneaspermus (HE) is a traditional medicinal plant used for treating various disease conditions. Selenium nanoparticles (SeNPs) possess various properties such as anticancer, antioxidant, etc. The objective of the present study is to conduct green synthesis of selenium nanoparticles using Hybanthus enneaspermus(HE) and evaluate their biocompatibility. Leaves of HE are utilized for synthesizing SeNPs. Characterization studies of HE-SeNPs are carried out using UV spectrophotometry, FT-IR spectroscopy, and SEM. To check the biocompatibility, hemolytic assay, and Annexin V-PI assays are carried out. A change in color is observed after the addition of sodium selenite to the leaf extract. UV spectrophotometry gives a peak at 271 nm confirming the synthesis of SeNPs. FT-IR gives peaks at 3224, 1565, 1399, 1078, 784, and 717 cm-1 with a fingerprint of 3500 - 1000 cm-1. SEM analysis shows the spherical morphology of the SeNPs. HE-SeNPs at lower concentrations cause less hemolysis. However, HE-SeNPs are found to be less biocompatible, so further studies are needed to confirm their biocompatible nature. SeNPs synthesized from HE can be ideal for biomedical applications but further studies are required to check its biocompatibility. Keywords: SeNPs, Hybanthus enneaspermus, green synthesis, biocompatibility.

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Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration

Vyas

Jadav

Patel

et al. 2023

AJPA

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Stability-indicating methods are crucial analytical techniques that aim to evaluate the stability of a drug substance or product over time. They are designed to detect any alterations in the drug's chemical, physical, or biological characteristics that may occur during storage, transportation, and usage. These modifications can significantly impact the drug's safety and effectiveness, making stability testing an integral part of pharmaceutical quality control. The stability-indicating methods are used to identify the degradation products of a drug, quantify the rate of degradation, and determine the factors that may contribute to degradation. These conditions can include exposure to light, heat, humidity, and various chemical and physical stressors. The methods can be chromatographic or spectrophotometric and undergo validation to ensure their reliability, accuracy, and specificity for the specific drug. The acceptable level of degradation in forced degradation studies should not exceed 5-30% of the total active ingredient present in the drug substance or product. This helps to ensure that the results obtained are trustworthy and can be used to make informed decisions about the stability of the drug.

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A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021

Cited by 4 publications

References 16 publications

Developing Automated Computer Algorithms to Phenotype Periodontal Disease Diagnoses in Electronic Dental Records

Developing Automated Computer Algorithms to Phenotype Periodontal Disease Diagnoses in Electronic Dental Records

Synthesis, Characterisation, and in Vitro Biocompatibility Studies of Selenium Nanoparticles Synthesized using Hybanthus Enneaspermus Plant Extract for Potential Biomedical Applications

Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration

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