International Journal of Research and Development in Pharmacy and Life Sciences最新文献

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Quality Improvement with Scientific Approaches (QbD, AQbD and PAT) in Generic Drug Substance Development: Review 科学方法(QbD, AQbD和PAT)在仿制药开发中的质量改进:综述

International Journal of Research and Development in Pharmacy and Life Sciences Pub Date : 2015-01-01 DOI: 10.4172/2278-0238.1000102

Raman Vvssn, Useni Reddy, Arunkanth Krishnakumar, Maheshwar Reddy, Hanimi Reddy, Narendra Kumar

{"title":"Quality Improvement with Scientific Approaches (QbD, AQbD and PAT) in Generic Drug Substance Development: Review","authors":"Raman Vvssn, Useni Reddy, Arunkanth Krishnakumar, Maheshwar Reddy, Hanimi Reddy, Narendra Kumar","doi":"10.4172/2278-0238.1000102","DOIUrl":"https://doi.org/10.4172/2278-0238.1000102","url":null,"abstract":"Drug substance synthesis requires strong chemistry knowledge and innovative thinking to publish and challenge patents. Creative synthetic route supports to have critical patent claims and challenges the entry of generic players in the market. Since innovators are covering many parameters like stereo selective (isomerism), polymorphic (crystallinity), salt or ester form, impurity profile apart from residual solvents, chemicals and reagents in their patents, drug substance synthesis is a big challenge to the generic manufacturers. Generic drug manufacturers target is to develop a simple and cost effective synthetic route to meet the market competition from other players. Drug substance development can be employed with two approaches traditional and/or scientific approaches. Traditional approach progressed with previous knowledge, reactions reproducibility, less experimental data when compared with scientific approach. In recent years all regulatory agencies are recommending to follow scientific approach rather than traditional approach. Scientific approach can be employed with scientific tools such as quality by design (QbD), analytical quality by design (AQbD) and process analytical technology (PAT) for process development and manufacturing. These three tools will provide enough understanding on drug development and manufacturing. Authors have discussed about quality improvement with scientific approaches.","PeriodicalId":14206,"journal":{"name":"International Journal of Research and Development in Pharmacy and Life Sciences","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85966985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

ESTIMATION OF AROMATASE ENZYME IN OBESE INFERTILE MEN 肥胖不育男性芳香酶测定

International Journal of Research and Development in Pharmacy and Life Sciences Pub Date : 2015-01-01 DOI: 10.28969/ijeir.v6.r4

U. Al-Kawaz, Nawal khairy Al-Ani, Andrew Wassef

{"title":"ESTIMATION OF AROMATASE ENZYME IN OBESE INFERTILE MEN","authors":"U. Al-Kawaz, Nawal khairy Al-Ani, Andrew Wassef","doi":"10.28969/ijeir.v6.r4","DOIUrl":"https://doi.org/10.28969/ijeir.v6.r4","url":null,"abstract":"Male obesity is associated with physiological changes that can negatively affect male fertility. Obese men have demonstrated a 3-fold increase in the prevalence of oligozoospermia when compared with men with normal Body Mass IndexBMI .The experiment was conducted to find the correlation between Aromatase enzyme and FSH, LH, E2 , testosterone and BMI. Seventy obese infertile male (patients) and twenty obese fertile male (control) are enrolled in this study. Aromatase enzyme, FSH, LH, E2 and testosterone hormones were measured in their serum.Median human cytochrome enzyme level was significantly higher in patients than in control group, 87.55 versus 56.95, (P= 0.014). In patients group, a significant positive correlation was found between human cytochrome enzyme, FSH and LH. The present study showed clearly that male obesity negatively impacts fertility through changes in hormone levels. The results suggest that increased estrogen as a result of aromatization in the fatty tissue, reflected through the increase in human cytochrome enzyme (aromatase), may be an important mechanism for the hypoandrogenemia and altered sperm parameters.","PeriodicalId":14206,"journal":{"name":"International Journal of Research and Development in Pharmacy and Life Sciences","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73410276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

ANTHELMINTIC ACTIVITY OF METHANOLIC EXTRACT OF RHIZOMES OF PICRORRHIZA KURROA ROYAL EX. BENTH 苦藤根茎甲醇提取物的驱虫活性研究

International Journal of Research and Development in Pharmacy and Life Sciences Pub Date : 2013-09-09 DOI: 10.7897/2230-8407.04826

A. Rajani, K. Hemamalini, D. Satyavati, S. Begum, Ndvr Saradhi

引用次数: 1

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