Latest ArticlesTo identify the quality risks of medical records in clinical research and propose strategies according to the risk levels.
By analyzing the quality inspection findings of clinical research in the recent 3 years, the quality risks of medical records in clinical research were identified. The risk coefficient was obtained by multiplying the degree of risk influence with the possibility of occurrence, and the risk grade was evaluated according to the risk coefficient.
A total of 54 risks were identified, mostly medium and low risks. The only high risk is inconsistent recording of the same data in different source files. Incomplete records, insufficient records to determine the clinical significance of detection outliers, missing adverse events and incomplete or incorrect records of adverse event elements are common risks of medical record quality, and the risk coefficient of which is second to the only high risk. Other risks with low risk coefficients are infrequently met.
The risk of medical record quality exists in every link of clinical study. Clinical research related personnel can establish the initial priority of risk treatment according to risk level and coefficient.
Lung cancer is the malignant tumor with the highest mortality, of which non-small cell lung cancer (NSCLC) is the most common type. Studies have confirmed that mutations of epidermal growth factor receptor (EGFR) are closely related to the development of non-small cell lung cancer. Related drugs targeting EGFR common mutations, such as deletion of exon 19, insertion of exon 20 and point mutation of exon 21, have been applied in clinical practice. However, mutations in the extracellular domain of EGFR were found in some patients with NSCLC. This rare mutation also affects the treatment of these patients. This review introduces the research progress of EGFR extracellular region mutations in non-small cell lung cancer, and explores effective treatments for such mutations, with the hope of providing a reference for the diagnosis and treatment of lung cancer patients with EGFR extracellular region mutations.
Alzheimer's disease (AD), as a multifactorial syndrome with several interconnected and deregulated pathological pathways, is one of the diseases with the highest incidence among the elderly population. The discovery and development of multitarget-directed ligands (MTDLs) have opened up a promising innovative drug therapy for neurodegenerative diseases, in particular for AD. Two or more pharmacophores are incorporated into a single drug small molecule of MTDLs, leading to a better pharmacokinetic profile and alleviated side effects. MTDLs are more helpful to treat AD than a single pharmacophore molecule. The innovative design and synthesis study of novel-type multi-targeted small-molecule anti-AD candidate drugs in recent years are summarized in this paper, providing theoretical basis for the development of effective anti-AD molecules.
Microspheres, as a new delivery system, are widely concerned in the field of medicine. Microspheres can be divided into solid microspheres, double-walled microspheres, hollow microspheres and porous microspheres according to their different structures. Different microstructure endows the microspheres with different characteristics, which makes the microspheres suitable for different drug delivery forms and clinical applications. In this paper, the characteristics, preparation methods and applications of microspheres with different structures are briefly introduced.
Solid dispersion (SD) is one of the most valuable methods to improve the solubility, dissolution rate and oral bioavailability of poorly soluble drugs. SD disperses poorly soluble drugs into carrier materials, and improves the solubility and dissolution of drugs by changing their dispersion state, increasing specific surface area, increasing wettability, and so on, so as to improve the bioavailability. Dissolution is one of the most important pharmacological properties of SD and is the basis for determining whether it can successfully improve the bioavailability for the poorly soluble drugs. In SD, the carrier material is the largest component in the formulation, and the nature of it is an important factor that affects the dissolution process and dissolution behavior. Based on these, this article reviews the effects of carrier materials on the dissolution behavior and saturation solubility of SD, and provides references of selecting a suitable carrier material for SD.
To establish a standard quality assessment method and a quality attribute standard of human mesenchymal stem cells (hMSCs) regulating the regulatory T cells (Treg).
Based on co-culturing of hMSCs with allogenic human peripheral blood mononuclear cells (PBMCs), flow cytometry, and a reference cell line CCRC-hMSC-S1 (CCRC1), a standard evaluation technique for hMSCs regulating Treg was established, which was further applied in quality attribute standard of hMSCs of various origins.
A percentage of (47.9±23.3)% was established as the preliminary standard quality attribute value of hMSCs regulating Treg. The differences in manufacturing processes, cell growth media, cell passage numbers, and tissue origins significantly affected the quality of hMSCs regulating Treg.
Through the development of the standardized evaluation technique, a preliminary quality attribute value of hMSCs regulating Treg function was established for the first time. The combination of the standardized assessment technique and the quality attribute value proved to be effective for quantitative evaluation of the quality of hMSCs and of great value in guiding the development of hMSCs products.
To determine the stable relationship of the polymorph system of prasugrel hydrogen sulfate, to clarify the influence rule of solvent on the polymorph nucleation of prasugrel hydrogen sulfate, and to reveal the crystal transformation mechanism of prasugrel hydrogen sulfate.
In this study, crystal forms Ⅰ and Ⅱ of prasugrel hydrogen sulfate were selected as the research subjects, focusing on their solvent-mediated transcrystallisation proces, the off-line monitoring of the crystal form composition of suspended solid phase and the change of the solution concentration with time during the crystallization process. The influence mechanism of solvent on the crystal transformation process was also revealed.
Solvent-mediated crystallization of Prasugrel hydrogen sulfate form Ⅰ to form Ⅱ was monitored by X-ray diffraction, the results of which indicated that the rate-determining step during this process was the nucleation and growth of the prasugrel hydrogen sulfate form Ⅱ.
Consider the crystal transformation rate of prasugrel hydrogen sulfate in three solvents, including butanone, MIK and methyl acetate, and the solubility relationship of crystal form Ⅱ in them, it can be concluded that the nucleation process of prasugrel hydrogen sulfate form Ⅱ is affected not only by solubility, but also by the strength of hydrogen bond between the molecules.
To develop an HPLC-DAD method for the simultaneous determination of the contents of 5 components (isochlorogenic acid A, isochlorogenic acid C, linarin, rupestonic acid, and chrysosptertin B) in Artemisia rupestris L.
The chromatographic separation was achieved on a InerSustainR C18 (250 mm×4.6 mm, 5 μm) column with acetonitrile (A)-0.2% phosphoric acid (B) as mobile phase at a flow rate of 1.0 mL·min-1 for gradient elution. Isochlorogenic acid A, isochlorogenic acid C, linarin, rupestonic acid and chrysosptertin B were detected at 320, 320, 334, 245, 350 nm, respectively. Injection volume was set at 10 μL. To establish an HPLC chromatographic fingerprint of Artemisia rupestris L., the similarity evaluation was carried out. The cluster analysis was performed by using SPSS 23.0 software.
There were 25 common peaks in HPLC fingerprint of 15 batches of Artemisia rupestris L. The similarities of 10 batches of samples were more than 0.85. The 10 batches of samples can be divided into 2 categories by cluster analysis.
The method is simple, quick, accurate, and helpful for the quality control of Artemisia rupestris L.
To explore the security alert signals of evolocumab after marketing using data mining technology in order to provide the basis for safe drug use in clinical.
FDA Adverse Event Reporting System (FAERS) were searched for 19 quarters since the drug was approved for marketing (3rd quarter of 2015) by the FDA to the 1st quarter of 2020. The measure of disproportionality included the reporting odds ratio and the proportional reporting ratio, the correlation degree of the adverse drug event (ADE) signals was simultaneously calculated.
After multiple screenings, the signals obtained by ROR and PRR completely overlapped in a total of 46 cases, of which 28 adverse event specifications were not appear in the specification. The strong signals of evolocumab were mainly concentrated in myalgia, injection site reaction, and back pain, etc. The largest number of system organ classification (SOC) signals were mainly concentrated in musculoskeletal and connective tissue disorders, infection and infectious diseases, and perception dysfunction, etc. At the same time, it has been discovered that the drug may cause nerve perception dysfunction and increased blood glucose, etc. Through further analysis of the adverse events related to gender and age differences, a total of 14 high-risk signals with gender differences were found. Male patients should be alert to increased blood creatine phosphokinase, and hypoacusis, etc; female patients should be alert to nervousness and swelling face, etc. There were 15 high risk signals with age differences. Non-elderly patients should be alert to increased blood creatine phosphokinase, and increased hepatic enzyme, etc; elderly patients should be alert to hypoacusis, and arthritis, etc.
The signal mining of adverse events through FAERS can deeply analyze the safety of evolocumab after it enters marketed, and then effectively reduce the risk of clinical medication.
This paper analyzed the relationship between the early resolution of patent disputes and the patent linkage regime in United States and conducted research on the judicial application of “artificial infringement” under § 271(e)(2), the disputes and legal reasoning of United States courts in regard to the issues that whether the Paragraph Ⅳ statement is a necessary prerequisite to determine jurisdiction and whether to extend the infringement object to the later-issued patents. Based on the perception of the function of the mechanism for early resolution of patent disputes in the United States, the status quo of China's pharmaceutical reformation policy, its legislation and legal practice in the field of pharmaceuticals, this paper proposed a better path to build the dispute resolution mechanism under the ongoing drug patent linkage system in China, that is, to solve the patent disputes between the brand-name company and the generic drug company in the specific case related to disputes over confirming the absence of infringement on patent rights, and to provide opportunity for the drug patentees to petition administrative objections.
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