Matches in SemOpenAlex for { <https://semopenalex.org/work/W2950603574> ?p ?o ?g. }
- W2950603574 abstract "Abstract Central nervous system (CNS) diseases represent one of the most challenging therapeutic areas for successful drug approvals. Developing biomarkers as drug development tools (DDTs) that catalyze the path to innovative treatments can aid in reducing the risk and improving the chances of approvals. Biomarker development, validation, and regulatory endorsement are a similarly rigorous process. Regulatory endorsement of biomarkers is a key goal for all stakeholders, and several paths exist with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). This chapter highlights the regulatory paths and considerations for advancing biomarker use in clinical development. Advancing biomarkers for CNS diseases is critical for advancing innovative therapeutics. Public-private partnerships (PPPs) provide the infrastructure for bringing together data and all relevant stakeholders in a precompetitive platform aimed at sharing costs and risks." @default.
- W2950603574 created "2019-06-27" @default.
- W2950603574 creator A5045300839 @default.
- W2950603574 creator A5073027575 @default.
- W2950603574 date "2019-01-01" @default.
- W2950603574 modified "2023-10-13" @default.
- W2950603574 title "Regulatory Science Objectives and Biomarker Qualification Through Public-Private Partnerships Are Critical to Delivering Innovative Treatments for CNS Diseases" @default.
- W2950603574 cites W114012934 @default.
- W2950603574 cites W1544047118 @default.
- W2950603574 cites W1583137789 @default.
- W2950603574 cites W1585083630 @default.
- W2950603574 cites W1693122999 @default.
- W2950603574 cites W177920909 @default.
- W2950603574 cites W1950484784 @default.
- W2950603574 cites W1964464904 @default.
- W2950603574 cites W1979801167 @default.
- W2950603574 cites W1981370726 @default.
- W2950603574 cites W1981788339 @default.
- W2950603574 cites W1984866003 @default.
- W2950603574 cites W1987262253 @default.
- W2950603574 cites W1988494453 @default.
- W2950603574 cites W1994964794 @default.
- W2950603574 cites W1997718099 @default.
- W2950603574 cites W2003418600 @default.
- W2950603574 cites W2009710524 @default.
- W2950603574 cites W2011334740 @default.
- W2950603574 cites W2013055132 @default.
- W2950603574 cites W2013129988 @default.
- W2950603574 cites W2017874571 @default.
- W2950603574 cites W2020279151 @default.
- W2950603574 cites W2028943878 @default.
- W2950603574 cites W2033345578 @default.
- W2950603574 cites W2033900397 @default.
- W2950603574 cites W2045299870 @default.
- W2950603574 cites W2051312070 @default.
- W2950603574 cites W2054082359 @default.
- W2950603574 cites W2057716620 @default.
- W2950603574 cites W2060427373 @default.
- W2950603574 cites W2063217142 @default.
- W2950603574 cites W2072747066 @default.
- W2950603574 cites W2080186325 @default.
- W2950603574 cites W2082544334 @default.
- W2950603574 cites W2083040497 @default.
- W2950603574 cites W2090540489 @default.
- W2950603574 cites W2097518261 @default.
- W2950603574 cites W2102068217 @default.
- W2950603574 cites W2105824687 @default.
- W2950603574 cites W2106457523 @default.
- W2950603574 cites W2107153099 @default.
- W2950603574 cites W2107768418 @default.
- W2950603574 cites W2111135373 @default.
- W2950603574 cites W2121393149 @default.
- W2950603574 cites W2124885415 @default.
- W2950603574 cites W2133868311 @default.
- W2950603574 cites W2140132003 @default.
- W2950603574 cites W2141464042 @default.
- W2950603574 cites W2143548516 @default.
- W2950603574 cites W2146249493 @default.
- W2950603574 cites W2146702846 @default.
- W2950603574 cites W2147504169 @default.
- W2950603574 cites W2152775372 @default.
- W2950603574 cites W2163526733 @default.
- W2950603574 cites W2166550586 @default.
- W2950603574 cites W2173982264 @default.
- W2950603574 cites W2179685565 @default.
- W2950603574 cites W2196234005 @default.
- W2950603574 cites W2250965630 @default.
- W2950603574 cites W2258913832 @default.
- W2950603574 cites W2266461367 @default.
- W2950603574 cites W2279154019 @default.
- W2950603574 cites W2300243664 @default.
- W2950603574 cites W2317887186 @default.
- W2950603574 cites W2342674545 @default.
- W2950603574 cites W2343290709 @default.
- W2950603574 cites W2411736734 @default.
- W2950603574 cites W2413971294 @default.
- W2950603574 cites W2511930323 @default.
- W2950603574 cites W2515364309 @default.
- W2950603574 cites W2521063752 @default.
- W2950603574 cites W2521523576 @default.
- W2950603574 cites W2522130662 @default.
- W2950603574 cites W2529649944 @default.
- W2950603574 cites W2536561406 @default.
- W2950603574 cites W2542946480 @default.
- W2950603574 cites W2547345427 @default.
- W2950603574 cites W2556037168 @default.
- W2950603574 cites W2557361306 @default.
- W2950603574 cites W2560688864 @default.
- W2950603574 cites W2566664155 @default.
- W2950603574 cites W2578940675 @default.
- W2950603574 cites W2597928394 @default.
- W2950603574 cites W2616456751 @default.
- W2950603574 cites W2620893222 @default.
- W2950603574 cites W2730375389 @default.
- W2950603574 cites W2732150368 @default.
- W2950603574 cites W2736686352 @default.
- W2950603574 cites W2742808332 @default.
- W2950603574 cites W2744140056 @default.
- W2950603574 cites W2746300323 @default.
- W2950603574 cites W2747311934 @default.