PURPOSE: This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs). MATERIALS AND METHODS: A multicenter, randomized, open label, two-period, crossover, single dose bioequivalence study was designed for conduct under fed conditions in 42 adult Ph+ CML patients already stabilized on imatinib 400 mg tablets. Pharmacokinetic parameters Tmax, Cmax, and AUC0-24 were calculated using a non-compartmental model on validated WinNonlin software. Validated SAS software was used for statistical evaluation of data. The safety profile of investigational products was monitored during the course of study by applying a clinical process for recording observed untoward effects postadministration of investigational products. RESULTS: The 90% confidence intervals for the test/reference mean ratios of the ln-transformed PK variables Cmax (99.0%) and AUC0-24 (99.2%) were within an acceptable range of 80%-125%, as per bioequivalence assumptions. Both formulations were well tolerated after oral administration of IMPs. CONCLUSION: The test product was found to be bioequivalent and safe, and thus can be used interchangeably in clinical practice.
Administration, Oral ; Adult ; Humans ; Imatinib Mesylate* ; Leukemia ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive* ; Mesylates ; Pharmacokinetics ; Philadelphia Chromosome ; Tablets* ; Therapeutic Equivalency*

STUDY DESIGN: Prospective study. PURPOSE: To compare magnetic resonance imaging (MRI) findings with clinical profile and neurological status of the patient and to correlate the MRI findings with neurological recovery of the patients and predict the outcome. OVERVIEW OF LITERATURE: Previous studies have reported poor neurological recovery in patients with cord hemorrhage, as compared to cord edema in spine injury patients. High canal compromise, cord compression along with higher extent of cord injury also carries poor prognostic value. METHODS: Neurological status of patients was assessed at the time of admission and discharge in as accordance with the American Spine Injury Association (ASIA) impairment scale. Mean stay in hospital was 14.11+/-5.74 days. Neurological status at admission and neurological recovery at discharge was compared with various qualitative cord findings and quantitative parameters on MRI. In 27 patients, long-term follow-up was done at mean time of 285.9+/-43.94 days comparing same parameters. RESULTS: Cord edema and normal cord was associated with favorable neurological outcome. Cord contusion showed lesser neurological recovery, as compared to cord edema. Cord hemorrhage was associated with worst neurological status at admission and poor neurological recovery. Mean canal compromise (MCC), mean spinal cord compression (MSCC) and lesion length values were higher in patients presenting with ASIA A impairment scale injury and showed decreasing trends towards ASIA E impairment scale injury. Patients showing neurological recovery had lower mean MCC, MSCC, and lesion length, as compared to patients showing no neurological recovery (p<0.05). CONCLUSIONS: Cord hemorrhage, higher MCC, MSCC, and lesion length values have poor prognostic value in spine injury patients.
Asia ; Contusions ; Edema ; Follow-Up Studies ; Hemorrhage ; Humans ; Magnetic Resonance Imaging* ; Prospective Studies ; Spinal Cord Compression ; Spine*

Although the health care systems in Europe are considered the global benchmark, European nations were severely affected by the coronavirus disease 2019 (COVID-19) pandemic. This manuscript aimed to examine the strategies implemented to combat the COVID-19 pandemic by France, the United Kingdom, Spain, Italy, Germany, and Russia and their outcomes in terms of the number of cases, testing, and deaths. This is the first review of its kind that extensively analyzes the preparedness, mitigation, and response strategies against the COVID-19 pandemic adopted by these nations. This paper further suggests a strategic preparedness model for future pandemics. From the analysis, we found that a decentralized approach, prompt decision-making and timely execution, coordination between local health authorities, and public participation in the implementation of strategies could substantially reduce the case fatality rate. Nations with a high percentage of gross domestic product invested in the health sector, as well as more nurses, physicians, hospital beds, intensive care unit beds, and ventilators, better managed the pandemic. Instead, nations that postponed their pandemic response by delaying tracking, tracing, testing, quarantine, and lockdown were badly affected. The lessons learned from the present pandemic could be used as a guide to prepare for further pandemics.

Although the health care systems in Europe are considered the global benchmark, European nations were severely affected by the coronavirus disease 2019 (COVID-19) pandemic. This manuscript aimed to examine the strategies implemented to combat the COVID-19 pandemic by France, the United Kingdom, Spain, Italy, Germany, and Russia and their outcomes in terms of the number of cases, testing, and deaths. This is the first review of its kind that extensively analyzes the preparedness, mitigation, and response strategies against the COVID-19 pandemic adopted by these nations. This paper further suggests a strategic preparedness model for future pandemics. From the analysis, we found that a decentralized approach, prompt decision-making and timely execution, coordination between local health authorities, and public participation in the implementation of strategies could substantially reduce the case fatality rate. Nations with a high percentage of gross domestic product invested in the health sector, as well as more nurses, physicians, hospital beds, intensive care unit beds, and ventilators, better managed the pandemic. Instead, nations that postponed their pandemic response by delaying tracking, tracing, testing, quarantine, and lockdown were badly affected. The lessons learned from the present pandemic could be used as a guide to prepare for further pandemics.