Efficient access to chemical information contained in scientific literature, patents, technical reports, or the web is a pressing need shared by researchers and patent attorneys from different chemical disciplines. Retrieval of important chemical information in most cases starts with finding relevant documents for a particular chemical compound or family. Targeted retrieval of chemical documents is closely connected to the automatic recognition of chemical entities in the text, which commonly involves the extraction of the entire list of chemicals mentioned in a document, including any associated information. In this Review, we provide a comprehensive and in-depth description of fundamental concepts, technical implementations, and current technologies for meeting these information demands. A strong focus is placed on community challenges addressing systems performance, more particularly CHEMDNER and CHEMDNER patents tasks of BioCreative IV and V, respectively. Considering the growing interest in the const...

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Information retrieval and text mining technologies for chemistry

Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. It is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event (ADE) detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources—such as biomedical literature, clinical narratives, product labeling, social media, and Web search logs—that are amenable to text mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

/pdf/text-mining-for-adverse-drug-events-the-promise-challenges-3uv8nuvzlh.pdf

Text Mining for Adverse Drug Events: the Promise, Challenges, and State of the Art

https://www.graceprinciples.org/doc/BergerDreyer_ValueInHealth_2012.pdf

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

Product competition, managerial discretion, and manufacturing recalls in the U.S. pharmaceutical industry

Intravenous carfilzomib is a peptide epoxyketone, next-generation proteasome inhibitor, which has been granted accelerated approval in the US for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (thalidomide or lenalidomide), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Carfilzomib displays high selectivity for and irreversibly inhibits the chymotrypsin-like catalytic activity of the 20S proteasome core particle, which results in cell growth arrest and apoptosis. In the pivotal, phase II, noncomparative trial in heavily pre-treated patients (n = 266) with relapsed and refractory multiple myeloma, intravenous carfilzomib administered in 28-day cycles for up to 12 cycles produced an overall response rate of 23.7% in the response-evaluable population. The median duration of response was 7.8 months, the median progression-free survival was 3.7 months and the median overall survival was 15.6 months. Carfilzomib had an acceptable tolerability profile in patients with relapsed, or relapsed and refractory, multiple myeloma. There was a low incidence of grade 3 or higher peripheral neuropathy.

Carfilzomib: in relapsed, or relapsed and refractory, multiple myeloma.

Application for marketing approval (US); FDA requests at least 2 independent, well-controlled clinical trials providing “substantial evidence” to gain approval, but approval has also been granted on the basis of one well-controlled clinical trial and confirmatory evidence form preclinical and clinical trials; the typical NDA approved in the mid-1990s came in with data from more than 80 clinical trials, but only 3–14 of them providing substantial evidence, and with 9% to 65% being “failed” studies; review for NDA by the FDA takes about 20 months and costs which are charged by the FDA may be in the order of ∼900,000.00 $ (∼500,000 in 1994); → see also establishment licence application, fda 356h form, product licence application, more and more electronic submission schemes are also coming in use such as SMART (Submission Management and Review Tracking) of the FDA and the CANDA (Computer Assisted New Drug Application); the basic fee for a nda is € 242 600 (EMEA 2008, single strength, one pharmaceutical form, one presentation); → see also marketing authorisation.

new drug application (NDA)

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new drug application (NDA)