{"title":"Deficiencies in the reporting of VD and t(1/2) in the FDA approved chemotherapy drug inserts.","authors":"Malcolm J D'Souza, Ghada J Alabed","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Since its release in 2006, the US Food and Drug Administration (FDA) final improved format for prescription drug labeling has revamped the comprehensiveness of drug inserts, including chemotherapy drugs. The chemotherapy drug \"packets\", retrieved via the FDA website and other accredited drug information reporting agencies such as the Physician Drug Reference (PDR), are practically the only available unbiased summary of information. One objective is to impartially evaluate the reporting of useful pharmacokinetic parameters, in particular, Volume of Distribution (V(D)) and elimination half-life (t(1/2)), in randomly selected FDA approved chemotherapy drug inserts. The web-accessible portable document format (PDF) files for 30 randomly selected chemotherapy drugs are subjected to detailed search and the two parameters of interest are tabulated. The knowledge of the two parameters is essential in directing patient care as well as for clinical research and since the completeness of the core FDA recommendations has been found deficient, a detailed explanation of the impact of such deficiencies is provided.</p>","PeriodicalId":89454,"journal":{"name":"Pharmaceutical reviews","volume":"8 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2010-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3106297/pdf/nihms199389.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29916058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Extracting Relevant Information from FDA Drug Files to Create a Structurally Diverse Drug Database Using KnowItAll<sup>®</sup>","authors":"Malcolm J D'Souza, Fumie Koyoshi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Each Food and Drug Administration (FDA) consumer drug information file contains an inordinate amount of useful chemical, pharmaceutical, and pharmacological data. These files profile approved drugs by chemical structure, solubility, absorption, distribution, metabolism, elimination, toxicity (ADME/Tox), and possible adverse reactions. The ability to utilize this data in the classroom is a new approach to connect theory, technology, and reality. The KnowItAll<sup>®</sup> Informatics System available through Bio-Rad Laboratories, Philadelphia, PA, offers fully integrated software and/or database desktop solutions. It holds a large collection of <i>in silico</i> ADME/Tox predictors and is a chemical informatics platform used to record experimental data. This project had three goals: (1) extract relevant information for 75 drugs from their freely available FDA drug files (limited to orally administrated drugs, pro-drugs, having a chemical structure), (2) build a database so this extracted FDA information is indexed for search and analysis, and when completed, (3) undergraduates involved in such a project should be capable of harvesting useful chemical, pharmaceutical, and pharmacological information; be adept in computational chemistry software tools; and should gain an enhanced vocabulary and new insights into organic chemistry, molecular biology, and physiology.</p>","PeriodicalId":89454,"journal":{"name":"Pharmaceutical reviews","volume":"7 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2009-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4209477/pdf/nihms202096.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32781858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}