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Comparison of German and American law concerning clinical trials. 德国与美国临床试验法律之比较。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
E Deutsch
{"title":"Comparison of German and American law concerning clinical trials.","authors":"E Deutsch","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial. In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial. In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written. The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards. The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"353-9"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732303","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
Legal requirements for drug testing in children in Germany. 德国对儿童药物测试的法律要求。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
H Hasskarl
{"title":"Legal requirements for drug testing in children in Germany.","authors":"H Hasskarl","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Since 1966 the problem of evaluation of drugs for use in man has increasingly become the subject of both international and national consideration. It was generally felt, that there is a need for a special protection for children being the subjects of the clinical evaluation of drugs. A new impulse with regard to the protection of children was recently set by the Council for International Organizations of Medical Sciences. German legislation has included these international convictions and recommendations pertaining to the performance of clinical trials. Articles 40 and 41 of the German Drug Law of 1976 are an emanation of WHO principles as well as of the Declaration of Helsinki. These articles include special provisions for the protection of children as volunteers of clinical trials, because clinical trials in children are indispensable for research on diseases of children. It is laid down in the Law that children should never be subject of research that might equally well be carried out on adults. The willing cooperation and, as far as feasible, consent of the child and its custodians has to be sought. The German Law provides that trials in healthy children may take place only with regard to diagnostic and prophylactic drugs, not with regard to the therapeutics. Article 41 of the German Drug Law permits the clinical evaluation of drugs in ill children. Therapeutic drugs may, however, be tested in children only under the condition that the drug is determined to cure the special disease under which the child is suffering. Special aspects of the clinical evaluation of drugs in children, not contained in the law, need further discussion and clarification.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"361-6"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732304","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
International Symposium on Pediatric Clinical Pharmacology. Düsseldorf, May 27 and 28, 1983. 国际儿科临床药理学研讨会。1983年5月27日和28日，杜塞尔多夫。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
{"title":"International Symposium on Pediatric Clinical Pharmacology. Düsseldorf, May 27 and 28, 1983.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"131-366"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732395","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
The role of therapeutic drug monitoring in childhood. 儿童治疗药物监测的作用。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
L O Boréus
{"title":"The role of therapeutic drug monitoring in childhood.","authors":"L O Boréus","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Therapeutic drug monitoring (TDM) can greatly improve the precision of drug therapy, provided 1) the analytical technique is sensitive, selective, and reproducable enough, 2) the pharmacokinetics of the drug is reasonably well known, and 3) the quantitative relation between kinetics and clinical effect is not too complicated. The TDM service must be supervised and further developed by a responsible group of experts, for example, a section or department of clinical pharmacology that should also provide service to help the physicians to take full advantage of the system. The appearance of active drug metabolites (for some drugs) and the considerable fluctuations in blood levels (in some patients) may complicate the interpretation. A cost-benefit analysis should continuously be made of the system; small, peripheral units for TDM may be too expensive to run.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"145-8"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732398","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
Oral phenytoin in infancy: dose requirement, absorption, and elimination. 婴儿口服苯妥英:剂量需求、吸收和消除。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
M Albani, I Wernicke
{"title":"Oral phenytoin in infancy: dose requirement, absorption, and elimination.","authors":"M Albani,&nbsp;I Wernicke","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Oral phenytoin therapy in infants required unexpectedly high doses of about 18 mg/kg body weight to achieve and to maintain serum concentrations between 8 and 25 micrograms/ml. Plasma half-life determined in 12 infants aged 6 weeks to 12 months ranged between 7.9 to 24.9 hours (mean 12.8 +/- 3.6 hours). Measurement of phenytoin metabolite excretion in urine during steady state revealed that only about 30% of the daily given phenytoin is eliminated through the kidneys. Studying the bioavailability of phenytoin in different age groups (infants, children, and adolescents) before and after ingestion of age-appropriate food showed an age-dependent absorption rate and extent, and an influence of the food upon the absorption pattern could be demonstrated. Mechanisms for this phenomenon of an impaired bioavailability of phenytoin in infancy are discussed.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"229-36"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732295","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
T4 levels in methylxanthine-treated premature newborns. 甲基黄嘌呤治疗的早产儿T4水平。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
H Sourgens, A H Staib, M Bielicki, V von Loewenich
{"title":"T4 levels in methylxanthine-treated premature newborns.","authors":"H Sourgens,&nbsp;A H Staib,&nbsp;M Bielicki,&nbsp;V von Loewenich","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The respiratory stimulants caffeine and theophylline are able to control apneic spells in premature newborns. However both substances have goitrogenic properties in rats on low-iodine diet. They lower T4 serum levels and inhibit TSH- and GH-release probably by enhancing hypothalamic somatostatin secretion. The retrospective study described here was carried out in an attempt to clarify whether treatment of premature children with methylxanthines has adverse effects on thyroid function. The results are as follows: 1) There is no significant correlation between caffeine- and theophylline-concentrations and circulating T4 levels in single blood specimen of unselected premature infants. 2) In none of the infants was a low T4-serum value accompanied by a rise in serum TSH during methylxanthine treatment. Thus methylxanthines are not associated with the induction of primary hypothyroidism but the possibility of tertiary hypothyroidism cannot be excluded. In order to avoid adverse effects on thyroid function the lowest therapeutically active dose should be chosen.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"267-72"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17732298","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
Gustav-Adolf von Harnack. 古斯塔夫·阿道夫·冯·哈纳克。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
D Reinhardt, G Heimann
{"title":"Gustav-Adolf von Harnack.","authors":"D Reinhardt,&nbsp;G Heimann","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"v-vi"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17436587","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
The benefits of drug monitoring in patients with bacterial meningitis, eg, chloramphenicol monitoring. 细菌性脑膜炎患者药物监测的益处，如氯霉素监测。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
H Rosin, A Crea, J Forster
{"title":"The benefits of drug monitoring in patients with bacterial meningitis, eg, chloramphenicol monitoring.","authors":"H Rosin,&nbsp;A Crea,&nbsp;J Forster","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Regular drug monitoring during therapy with chloramphenicol sodium succinate is actually recommended by expert centers. In this report a case of meningitis due to Salmonella typhimurium is described, which underlines the necessity of examining both the chloramphenicol and the chloramphenicol succinate concentrations. It is suggested that medical microbiologists and clinicians should be encouraged to take advantage of new, quick, and sensitive methods for drug monitoring in order to achieve optimal therapy.</p>","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 3-4","pages":"175-80"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17436588","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
Serum digoxin levels in neonates under 1500 grams. 1500克以下新生儿血清地高辛水平。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
G G Sandor, G Reid, M W Patterson
{"title":"Serum digoxin levels in neonates under 1500 grams.","authors":"G G Sandor,&nbsp;G Reid,&nbsp;M W Patterson","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 1","pages":"57"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17702181","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
The accuracy of amikacin administration in neonates. 新生儿阿米卡星给药的准确性。
Pediatric pharmacology (New York, N.Y.) Pub Date : 1983-01-01
J B Philips, M Geerts, A Dew, G Cassady
{"title":"The accuracy of amikacin administration in neonates.","authors":"J B Philips,&nbsp;M Geerts,&nbsp;A Dew,&nbsp;G Cassady","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77932,"journal":{"name":"Pediatric pharmacology (New York, N.Y.)","volume":"3 2","pages":"127-30"},"PeriodicalIF":0.0,"publicationDate":"1983-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"17729604","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
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