Journal of parenteral science and technology : a publication of the Parenteral Drug Association最新文献_第10页

A novel formulation of an ophthalmic beta-adrenoceptor antagonist. 一种眼科-肾上腺素能受体拮抗剂的新配方。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-03-01

R N Weinreb, R Jani

引用次数: 0

The insufficiency of single point diffusive air flow integrity testing. 单点扩散气流完整性测试的不足。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

T H Meltzer

{"title":"The insufficiency of single point diffusive air flow integrity testing.","authors":"T H Meltzer","doi":"","DOIUrl":"","url":null,"abstract":"Filter manufacturers characterize a given filter type by a single acceptable maximum diffusive air flow level. A too high value is prudently rejected as signalling the possible presence of flaws. Values lower than the stipulated maximum are accepted. However, the presence of single pores, whatever their sizes, is not being revealed. Only their influence within the total porosity is measured by the diffusive air flow. Single point diffusive air flow integrity testing may invite misleading conclusions because it offers possibilities for lower air flows to mask the presence of flaws or of outsized pores. This is particularly so where initial (prefiltration) and final integrity are being compared. The filtrative accretion of retained material, viable or not, must inevitably come to block or diminish the size of the pores. This results in decreased total porosity, directly expressed in lower diffusive air flow values. Sufficient drop in such final air flow values may mask the presence of a flaw developed in the filter subsequent to its initial testing. For this reason a filter's entire air flow permeation curve, particularly including its bubble point, must be characterized. It is this measurement, and this measurement alone, that is capable of unambiguously revealing the existence of insufficiently retentive pores. The inquiry into such presence is the very purpose of filter integrity testing.","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 1","pages":"19-21"},"PeriodicalIF":0.0,"publicationDate":"1992-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12790803","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: 0

Role of calcium and arachidonic acid metabolites in creatine kinase release from isolated rat skeletal muscles damaged by organic cosolvents. 钙和花生四烯酸代谢物在有机共溶剂损伤大鼠离体骨骼肌肌酸激酶释放中的作用。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

G A Brazeau, S S Watts, L S Mathews

{"title":"Role of calcium and arachidonic acid metabolites in creatine kinase release from isolated rat skeletal muscles damaged by organic cosolvents.","authors":"G A Brazeau, S S Watts, L S Mathews","doi":"","DOIUrl":"","url":null,"abstract":"The objective of the present work is to provide additional experimental evidence which can help to differentiate between a direct solubilization mechanism versus an intracellular calcium mechanism of organic cosolvent-induced creatine kinase release from isolated rat skeletal muscles. An increase in cytosolic free calcium levels following exposure to propylene glycol was evaluated indirectly through the measurement of skeletal muscle glycogen levels. Skeletal muscle glycogen levels decreased significantly in propylene glycol-treated muscles compared to normal saline-treated controls; providing further evidence for the possible role of increased cytosolic calcium in organic cosolvent-induced muscle damage. The possible involvement of prostaglandins and leukotrienes which disrupt membrane integrity leading to propylene glycol-induced creatine kinase release was investigated via the use of cyclo-oxygenase and lipoxygenase inhibitors. Organic cosolvent-induced creatine kinase release was not significantly reduced when the muscles were incubated in the presence of cyclo-oxygenase inhibitors, lipoxygenase inhibitors, or a combination of a cyclo-oxygenase and lipoxygenase inhibitor. These findings suggest that in this experimental system prostaglandins and leukotrienes do not seem to be involved in organic cosolvent-induced alterations in sarcolemma integrity leading to the release of creatine kinase.","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 1","pages":"25-30"},"PeriodicalIF":0.0,"publicationDate":"1992-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12790807","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: 0

Containment: comprehensive assessment and integrated control. 遏制:全面评估和综合控制。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

J Van Houten

引用次数: 0

Apples, oranges, and additive assurance. 苹果，橘子和添加剂保证。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

J Akers, J Agalloco

引用次数: 0

Effects of gamma irradiation on elastomeric closures. A Parenteral Drug Association Task Force report. 伽马辐照对弹性体闭孔的影响。一份肠外药物协会特别工作组的报告。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

引用次数: 0

Preparation and stability of intravenous solutions of sodium dichloroacetate (DCA). 静脉注射二氯乙酸钠溶液的制备及稳定性。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

P I Chu, S H Curry, T G Baumgartner, G N Henderson, P W Stacpoole

引用次数: 0

Achieving synergy and strength: an industry perspective on the Food and Drug Administration. 实现协同和实力:食品药品监督管理局的行业视角。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

M Novitch

引用次数: 0

Empirical calibration of light blockage sensors. 光阻传感器的经验校准。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

A W Russell

引用次数: 0

Industrial perspective on validation of tangential flow filtration in biopharmaceutical applications. Technical Report No. 15. Parenteral Drug Association. Biotechnology Task Force on Purification and Scale-up. 切向流过滤在生物制药应用中验证的工业前景。技术报告第15号注射药物协会。生物技术净化和扩大工作小组。

Journal of parenteral science and technology : a publication of the Parenteral Drug Association Pub Date : 1992-01-01

{"title":"Industrial perspective on validation of tangential flow filtration in biopharmaceutical applications. Technical Report No. 15. Parenteral Drug Association. Biotechnology Task Force on Purification and Scale-up.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"Validation of tangential flow filtration is required to ensure the process delivers a product of consistent quality, safety, and efficacy. A thorough and sound validation program not only satisfies regulatory requirements, but also provides a valuable source of information which facilitates development of future processes, training of production personnel, and trouble shooting for the validated process. Validation of TFF shares many common elements with validation of other traditional operations and equipment. Existing personnel and procedures should be readily adapted to execute the TFF validation protocols. IQ's and OQ's will most likely follow familiar formats. In performance qualification, key areas needing attention include: assessment of compatibles, testing of parameters affecting membrane retention and selectivity, cleaning, sanitization, and membrane lifetime. Finally, the hallmark of a sound validation program is the quality of its scientific approach and its congruence with the definition of validation contained in the 1987 guidelines (6).","PeriodicalId":16667,"journal":{"name":"Journal of parenteral science and technology : a publication of the Parenteral Drug Association","volume":"46 Suppl 1 ","pages":"S1-13"},"PeriodicalIF":0.0,"publicationDate":"1992-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12603475","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: 0