Adverse drug reactions and toxicological reviews最新文献_第8页

Review of alternative methods of carcinogenicity testing and evaluation of human pharmaceuticals. 人类药物致癌性测试和评价的替代方法综述。

Adverse drug reactions and toxicological reviews Pub Date : 1997-11-01

K Van Deun, H Van Cauteren, J Vandenberghe, M Canning, P Vanparys, W Coussement

{"title":"Review of alternative methods of carcinogenicity testing and evaluation of human pharmaceuticals.","authors":"K Van Deun, H Van Cauteren, J Vandenberghe, M Canning, P Vanparys, W Coussement","doi":"","DOIUrl":"","url":null,"abstract":"Hundreds of pharmaceuticals have been reported to give a positive result in the standard \"Chronic Bioassay\", which consists of an 18 to 24 month daily administration of the test compound in mice and rats. This is in contrast with 20 pharmaceuticals, which are known to be carcinogenic to humans. The high incidence of apparently false-positive results in the Chronic Bioassay may be related to differences in mechanism of pharmacological action between rodents and humans, but also to the very high dose levels that have to be administered to rodents in accordance to regulatory guidelines. Lack of relevance to man therefore often has to be demonstrated by additional mechanistic studies. Based upon the deficiencies of the Chronic Bioassay and on the increased knowledge on cellular and molecular mechanisms involved in carcinogenicity, extensive discussions have recently taken place between regulatory agencies and industry associations at the occasion of International Conferences on Harmonization (ICH). These discussions have resulted in the possibility to use alternative short-to-medium-term carcinogenicity models in combination with a single two-year carcinogenicity study for evaluation of carcinogenicity. A description of these models is provided in this review as well as possible strategies for carcinogenicity testing and evaluation in the future.","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"16 4","pages":"215-33"},"PeriodicalIF":0.0,"publicationDate":"1997-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20529131","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

Adverse effects of cytotoxics-platinum agents. 细胞毒素-铂制剂的不良反应。

Adverse drug reactions and toxicological reviews Pub Date : 1997-08-01

G Selvaratnam, R H Philips, A K Mohamed, A Radzi

引用次数: 0

ICH4: a report and background. ICH4:报告和背景。

Adverse drug reactions and toxicological reviews Pub Date : 1997-08-01

P F D'Arcy

引用次数: 0

Neurological syndromes of organophosphorus compounds. 有机磷化合物引起的神经系统综合症。

Adverse drug reactions and toxicological reviews Pub Date : 1997-08-01

G A Jamal

{"title":"Neurological syndromes of organophosphorus compounds.","authors":"G A Jamal","doi":"","DOIUrl":"","url":null,"abstract":"In addition to the acute cholinergic poisoning, organophosphorus (OP) compounds are capable of producing several subacute, delayed and chronic neurological, neurobehavioural and psychiatric syndromes. These include the intermediate syndrome, the organophosphate induced delayed neuropathy (OPIDN) and a number of chronic neurological and psychiatric manifestations lumped in this review under the term chronic organophosphate induced neuropsychiatric disorder (COPIND). A critical review of the concept of the neuropathy target esterase (NTE) inhibition and ageing as a marker of OPIDN and the related hen test is presented. It is concluded that the use of the hen test as an exclusive screening test for neurotoxicity of organophosphorus compounds is flawed. A number of recent studies are presented to demonstrate the unreliability of the test and flaws of scientific concepts underlying the hen test which is used to identify OPs as safe and \"non-neurotoxic\". The components of this new COPIND syndrome are described and the evidence for its existence is reviewed. Studies are in progress to further determine the profile of this syndrome and to define the overlap between its various components. The review also attempts to determine the clinical features so far described of these components and the investigations or markers used to identify and characterize COPIND and the behaviour of these markers. Evidence for chronic neurological/psychiatric effects of OP compounds have come from case studies, clusters of neurological diseases or from epidemiological investigations. New concepts in neurotoxicology are being produced from recent studies which may necessitate a new radical approach to the assessment of neurotoxicity of pesticides before releasing them for widespread use.","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"16 3","pages":"133-70"},"PeriodicalIF":0.0,"publicationDate":"1997-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20436020","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

Opinion of the EMEA on the potential risk associated with medicinal products in relation to bovine spongiform encephalopathy (BSE) (16 April 1996) and report from the Committee for Proprietary Medicinal Products (CPMP) on the 'Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathies via medicinal products' (15 April 1997). EMEA关于与牛海绵状脑病(BSE)相关的药品潜在风险的意见(1996年4月16日)和专利药品委员会(CPMP)关于“最小化通过药品传播动物海绵状脑病风险的指导说明”的报告(1997年4月15日)。

Adverse drug reactions and toxicological reviews Pub Date : 1997-06-01

引用次数: 0

Famous names: The Esing Bakery, Hong Kong. 著名品牌:香港艾辛烘焙坊。

Adverse drug reactions and toxicological reviews Pub Date : 1997-06-01

J P Griffin

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Drug-related hyperprolactinaemia. 毒品hyperprolactinaemia。

Adverse drug reactions and toxicological reviews Pub Date : 1997-06-01

P H Davies

引用次数: 0