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51.
Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case studies to demonstrate the potential application of absorption modeling in rational design of drug product under the QbD paradigm. The examples include application of absorption modeling—(1) prior to first-in-human studies to guide development of a formulation with minimal sensitivity to higher gastric pH and hence reduced interaction when co-administered with PPIs and/or H2RAs, (2) design of a controlled release formulation with optimal release rate to meet trough plasma concentrations and enable QD dosing, (3) understanding the impact of API particle size distribution on tablet bioavailability and guide formulation design in late-stage development, (4) assess impact of API phase change on product performance to guide specification setting, and (5) investigate the effect of dissolution rate changes on formulation bioperformance and enable appropriate specification setting. These case studies are meant to highlight the utility of physiologically based absorption modeling in gaining a thorough understanding of the product performance and the critical factors impacting performance to drive design of a robust drug product that would deliver the optimal benefit to the patients.KEY WORDS: absorption modeling, PBPK, pharmacokinetics, Quality by Design (QbD), quality target product profile (QTPP) 相似文献
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Watson RE Stein AD Dwamena FC Kroll J Mitra R McIntosh BA Vasilenko P Holmes-Rovner MM Chen Q Kupersmith J;Michigan State University Inter-Institutional Collaborative Heart Study Group 《Journal of general internal medicine》2001,16(4):227-234
OBJECTIVE: To assess the influence of race and gender influence on the use of invasive procedures in patients with acute myocardial infarction (AMI) in community hospitals. DESIGN: Prospective, observational. SETTING: Five mid-Michigan community hospitals. PATIENTS: All patients (838) identified with AMI between January 1994 and April 1995 in 1 of these hospitals. MEASUREMENTS AND MAIN RESULTS: After adjusting for age, hospital of admission, insurance type, severity of AMI, and comorbidity, using white men as the reference group, the rate of being offered cardiac catheterization (CC) was 0.88 (95% confidence interval [95% CI], 0.60 to 1.29) for white women; 0.79 (95% CI, 0.41 to 1.50) for black men; and 1.14 (95% CI, 0.53 to 2.45)for black women. Among patients who underwent CC, after also adjusting for coronary artery anatomy, the rate of being offered angioplasty, using white men as the reference group, was 1.22 (95% CI, 0.75 to 1.98) for white women; 0.61 (5% CI, 0.29 to 1.28, P =.192) for black men; and 0.40 (95% CI, 0.14 to 1.13) for black women The adjusted rate of being offered bypass surgery was 0.47 (95% CI, 0.24 to 0.89) for white women; 0.36 (95% CI, 0.12 to 1.06) for black men; and 0.37 (95% CI, 0.11 to 1.28)for black women. CONCLUSIONS: Our study shows that white women are less likely than white men to be offered bypass surgery after AMI. Although black men and women with AMI are less likely than white men to be offered percutaneous transluminal coronary angioplasty or coronary artery bypass grafting in both unadjusted and adjusted analyses, these findings did not reach statistical significance. Our study is limited in power due to the small number of blacks in the sample. 相似文献
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Mitra Samareh Fekri Mehdi Torabi Sara Azizi Shoul Moghaddameh Mirzaee 《The American journal of emergency medicine》2018,36(2):277-280
Background
Pulmonary hypertension (PH) is one of the most common complications of COPD (chronic obstructive pulmonary disease), but its severe form is uncommon. Various factors play an important role in the occurrence and severity of pulmonary hypertension in patients.Methods
This cross-sectional study was performed on patients with COPD referred to an emergency department over a one-year period. The tests—including complete blood count (CBC) and arterial blood gas (ABG), pulmonary functional test (PFT) and echocardiography—were performed for all patients to measure mPAP (mean pulmonary artery pressure), ejection fraction (EF) and body mass index (BMI). The prevalence of severe pulmonary hypertension and its associated factors were investigated in these patients.Results
A total of 1078 patients was included in the study, of whom 628 (58.3%) were male and 450 (41.7%) were female. The mean age of the patients undergoing the study was 70.1 ± 12.2. A total of 136 (13.7%) of them had mPAP (mm Hg) ≥ 40 mm Hg as severe pulmonary hypertension. Following multivariable analysis by using the backward conditional method, it was shown that seven variables had a significant correlation with severe PH.Conclusions
The results showed that there is an independent correlation between hypoxia, hypopnea and compensatory metabolic alkalosis, polycythemia, left ventricular dysfunction, emaciation, and cachectic with severe pulmonary hypertension. The prevalence of severe PH in these patients was 13.7%. 相似文献57.
58.
Mitra Sanjana Grant Cameron Nolan Seonaid Mohd Salleh Nur Afiqah Milloy M.-J. Richardson Lindsey 《AIDS and behavior》2022,26(6):1933-1942
AIDS and Behavior - A robust evidence-base describes the beneficial association between opioid agonist therapy (OAT) and HIV-related outcomes among people living with HIV and opioid use disorder.... 相似文献
59.
Parth Makker MD Moussa Saleh MD Aditi S. Vaishnav MBBS Kristie M. Coleman RN Stuart Beldner MD Haisam Ismail MD Nikhil Sharma MD Ram Jadonath MD Bruce Goldner MD Raman Mitra MD PhD Laurence Epstein MD Roy John MD Stavros E. Mountantonakis MD 《Journal of cardiovascular electrophysiology》2021,32(6):1658-1664
60.
Saha Soma Pal Dey Poushali Mitra Souvik 《Proceedings of the National Academy of Sciences, India. Section B.》2021,91(4):919-927
Proceedings of the National Academy of Sciences, India Section B: Biological Sciences - Microbial association is considered as a significant innovation for land colonization of mosses. Plagiomnium... 相似文献