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Advanced Search Results For "REGULATORY approval"

1 - 10 of 7,879 results for
 "REGULATORY approval"
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Regulatory Approval and Biotechnology Product Disclosures*†.

Publication Type:Academic Journal

Source(s):Contemporary Accounting Research. Sep2022, Vol. 39 Issue 3, p1689-1725. 37p.

Abstract:RÉSUMÉ: Approbation réglementaire et informations sur les produits biotechnologiques Cette étude examine l'effet de l'approbation réglementaire sur les divulgations volontaires d'une entreprise au niveau des produits. Les auteurs se concentrent sur l'i...

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Exploring innovation capabilities build up in the deployment of crop biotechnology innovation in Kenya.

Publication Type:Academic Journal

Source(s):Innovation & Development. Aug2022, Vol. 12 Issue 2, p305-324. 20p.

Abstract:Agro-biotechnology deployment has been very slow in Africa, yet it has potential for enhancing sustainable development and industrialization. This paper attempts to understand the underlying factors that characterize the new technologies' deployment pr...

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Real-world studies: bridging the gap between trial-assessed efficacy and routine care.

Publication Type:Academic Journal

Source(s):Journal of Biomedical Research. May2022, Vol. 36 Issue 3, p147-154. 8p.

Abstract:Even though randomized controlled clinical trials (RCTs) have been accepted as the gold standard for official assessment of novel interventions, there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in...

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A meta‐analysis on employee perceptions of human resource strength: Examining the mediating versus moderating hypotheses.

Publication Type:Academic Journal

Source(s):Human Resource Management; Jan2022, Vol. 61 Issue 1, p5-20, 16p

Abstract:Copyright of Human Resource Management is the property of John Wiley & Sons, Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print...

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A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.

Publication Type:Academic Journal

Source(s):CTS: Clinical & Translational Science; Aug2022, Vol. 15 Issue 8, p1959-1967, 9p

Abstract:Copyright of CTS: Clinical & Translational Science is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may p...

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WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021.

Publication Type:Academic Journal

Source(s):Biologicals. Apr2022, Vol. 76, p1-9. 9p.

Abstract:The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultatio...

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Ongoing Challenges to Develop High Concentration Monoclonal Antibody-based Formulations for Subcutaneous Administration: Quo Vadis?

Publication Type:Academic Journal

Source(s):Journal of Pharmaceutical Sciences. Apr2022, Vol. 111 Issue 4, p861-867. 7p.

Abstract:Although many subcutaneously (s.c.) delivered, high-concentration antibody formulations (HCAF) have received regulatory approval and are widely used commercially, formulation scientists are still presented with many ongoing challenges during HCAF devel...

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An intelligent methodology for the use of multi-criteria decision analysis in impact assessment: the case of real-world offshore construction.

Publication Type:Academic Journal

Source(s):Scientific Reports; 9/7/2022, Vol. 12 Issue 1, p1-14, 14p

Abstract:Copyright of Scientific Reports is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or ...

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Contextual Considerations and Recommendations for Estimating the Value of Alzheimer's Disease Therapies.

Publication Type:Academic Journal

Source(s):PharmacoEconomics. Oct2021, Vol. 39 Issue 10, p1101-1107. 7p.

Abstract:The pipeline for new treatments for Alzheimer's disease (AD) in the USA contains over 100 different agents, 80% of which can be categorized as disease-modifying therapies. The regulatory approval of the disease-modifying agent aducanumab has brought mo...

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