Market withdrawal of new molecular entities approved in the United States from 1980 to 2009

Qureshi, Zaina P.; Seoane‐Vazquez, Enrique; Rodríguez-Monguió, Rosa; Stevenson, Kurt B.; Szeinbach, Sheryl L.

doi:10.1002/pds.2155

Cited by 138 publications

(90 citation statements)

References 20 publications

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“…Cardiotoxicity has resulted in drug failures late in the clinical development process and drug withdrawal from the market due to pro-arrhythmic side effects which were only detected in humans in clinical trials or in post-marketing surveillance [6,[109][110][111]. Formulation strategies to reduce cardiotoxicity of drug compounds can be incorporated into drug products.…”

Section: Heartmentioning

confidence: 99%

“…Clinical trials can cost up to 2 billion dollars and may last up to 9 years on average with no guarantee of success [4,5]. It is reported that 3.5% of drugs approved in the US from 1980 to 2009 were forced to withdraw from the market due to safety concerns, with such decisions incurring huge financial losses [6]. In addition, drug development is increasingly moving toward biotechnology-type drug products which are more complex and expensive to develop and produce, thus presenting greater risks of failure.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Life in 3D is never flat: 3D models to optimise drug delivery

Fitzgerald

Malhotra

Curtin

et al. 2015

Journal of Controlled Release

195

126

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Section: Heartmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Life in 3D is never flat: 3D models to optimise drug delivery

Fitzgerald

Malhotra

Curtin

et al. 2015

Journal of Controlled Release

195

126

View full text Add to dashboard Cite

“…70 Another report cites that approximately one in seven US FDA-approved NMEs were discontinued from the market in the period 1980-2009. 71 In vitro toxicology studies have again relied heavily upon animal cell lines and immortalised cell lines. The poor predictive power is in part due to inherent species differences in drug metabolising enzyme activities and cell type-specic susceptibility to toxicants.…”

Section: Toxicity Testing Using Ipsc-based Modelsmentioning

confidence: 99%

Utility of Human Stem Cells for Drug Discovery

Chintawar¹,

Gräf²,

Cader³

2014

Human-Based Systems for Translational Research

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The pharmaceutical industry continues to struggle to deliver novel and innovative medicines to the market. One of the major challenges in deriving new therapeutics is to more accurately predict the safety and efficacy of the candidate molecule. The current paradigm of drug discovery has several limitations but perhaps the most conspicuous deficiency is the lack of human-based experimental models. The advent of human embryonic stem cells followed by the discovery of induced pluripotent stem (iPS) cells offers unprecedented opportunities for integrating human cellular assays in drug discovery and development. Human iPS cell lines of many diseases have been obtained and iPSC-derived disease affected cells have been utilised for proof-of-concept drug screens to assess efficacy or potential toxicology. The incorporation of iPSC technology thus provides an invaluable opportunity to reduce drug attrition during the process of drug development.

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“…The most common and preferred method of communicating safety information is through the DHP letters Théophile et al, 2011). Studies have revealed that about 10 to 14% of the registered medicinal products require DHP letters to inform health workers about newly identified risks within the first 3 years of their marketing authorization and also about 22% of drugs issued marketing authorization are withdrawn within the first 6 years for safety reasons which must be communicated to health workers to ensure patient safety (Arnardottir et al, 2011;Giezen et al 2008;Qureshi et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

Sabblah¹,

Darko²,

Asamoa-Amoakohene³

et al. 2016

Afr. J. Pharm. Pharmacol.

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Dear Healthcare Professional (DHP) letter is a risk minimization tool used to inform health workers about new and emerging safety information during the marketing period of medicinal products. DHP letters in some cases may not be effective because targeted audience may not be aware of these letters or even understand them. The objectives of this study were to assess the effectiveness and relevance of DHP letters as effective risk minimization tool and to seek opinion of health workers about the most effective way of communicating safety information. A descriptive correlational study of 913 health workers selected by convenient sampling through face-to-face interviews from Apr. to June, 2014 was conducted, with a response rate of 83.15%. The data was analyzed using descriptive analysis and Pearson-chi square test (χ 2 ) with STATA version 13. A p-value of < 0.05 was considered significant during the analysis. Of the 913 respondents only 350 (38.34%) were aware of at least one of the letters distributed in 2013 and 314 (89.71%) out of these admitted that these letters have influenced their way of prescribing, dispensing and administering the medicines involved. One hundred and ninety-two (54.82%) of the respondents rated the level of understanding of the language used as good and there was no significant difference in the health workers rating of the language used in the letters (p=0.40). Health workers suggested electronic methods such as short messaging service to their mobile phones 56.81% (438), e-mail 91 (85.85%) and posting the letters on the Food and Drugs Authority's website 26.85% (207). The results suggest that DHP letters issued by the Food and Drugs Authority (FDA) are effective in changing behavior of those who receive them but they are received late or not at all. The FDA should therefore explore other means of communicating safety information such as electronic means as suggested by the health workers.

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Market withdrawal of new molecular entities approved in the United States from 1980 to 2009

Cited by 138 publications

References 20 publications

Life in 3D is never flat: 3D models to optimise drug delivery

Life in 3D is never flat: 3D models to optimise drug delivery

Utility of Human Stem Cells for Drug Discovery

The effectiveness of dear healthcare professional letters as a risk minimization tool in Ghana

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