Search Results - "Lumpkin, M"

"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials? by Eichler, H-G, Bloechl-Daum, B, Bauer, P, Bretz, F, Brown, J, Hampson, LV, Honig, P, Krams, M, Leufkens, H, Lim, R, Lumpkin, MM, Murphy, MJ, Pignatti, F, Posch, M, Schneeweiss, S, Trusheim, M, Koenig, F

“…A central question in the assessment of benefit/harm of new treatments is: how does the average outcome on the new treatment (the factual) compare to the…”
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From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients by Eichler, H-G, Baird, LG, Barker, R, Bloechl-Daum, B, Børlum-Kristensen, F, Brown, J, Chua, R, Del Signore, S, Dugan, U, Ferguson, J, Garner, S, Goettsch, W, Haigh, J, Honig, P, Hoos, A, Huckle, P, Kondo, T, Le Cam, Y, Leufkens, H, Lim, R, Longson, C, Lumpkin, M, Maraganore, J, O'Rourke, B, Oye, K, Pezalla, E, Pignatti, F, Raine, J, Rasi, G, Salmonson, T, Samaha, D, Schneeweiss, S, Siviero, PD, Skinner, M, Teagarden, JR, Tominaga, T, Trusheim, MR, Tunis, S, Unger, TF, Vamvakas, S, Hirsch, G

“…The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and…”
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Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval by Eichler, H‐G, Oye, K, Baird, L G, Abadie, E, Brown, J, Drum, C L, Ferguson, J, Garner, S, Honig, P, Hukkelhoven, M, Lim, J C W, Lim, R, Lumpkin, M M, Neil, G, O'Rourke, B, Pezalla, E, Shoda, D, Seyfert‐Margolis, V, Sigal, E V, Sobotka, J, Tan, D, Unger, T F, Hirsch, G

“…Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a…”
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The cost of entry: An analysis of pharmaceutical registration fees in low-, middle-, and high-income countries by Morgan, Steven G, Yau, Brandon, Lumpkin, Murray M

“…Advances in pharmaceuticals offer improved health outcomes for a wide range of illnesses, yet medicines are often inaccessible for many patients worldwide. One…”
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The COVID‐19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics by Soumyanarayanan, Uttara, Choong, Mimi, Leong, James, Lumpkin, Murray M., Rasi, Guido, Skerritt, John H., Vogel, Silke, Lim, John C. W.

“…The need for regulatory agility and coordination among national regulatory authorities (NRAs) is more critical than ever to ensure that new health products can…”
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Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need by Hirsch, G, Trusheim, M, Cobbs, E, Bala, M, Garner, S, Hartman, D, Isaacs, K, Lumpkin, M, Lim, R, Oye, K, Pezalla, E, Saltonstall, P, Selker, H

“…The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation…”
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Acrolein health effects by Faroon, O, Roney, N, Taylor, J, Ashizawa, A, Lumpkin, MH, Plewak, DJ

“…Abstract Acrolein is a chemical used as an intermediate reactive aldehyde in chemical industry. It is used for synthesis of many organic substances, methionine…”
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Acrolein environmental levels and potential for human exposure by Faroon, O, Roney, N, Taylor, J, Ashizawa, A, Lumpkin, MH, Plewak, DJ

“…This article provides environmental information on acrolein including environmental fate, potential for human exposure, analytical methods, and a listing of…”
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Advancing the Science of Medicines Regulation: The Role of the 21st-Century Medicines Regulator by Lumpkin, M M, Eichler, H-G, Breckenridge, A, Hamburg, M A, Lönngren, T, Woods, K

“…The history of medicines regulation is punctuated with sudden swings in focus mandated by a public injured by medicines and skeptical of regulators' abilities…”
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The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem? by Friedman, Michael A, Woodcock, Janet, Lumpkin, Murray M, Shuren, Jeffrey E, Hass, Arthur E, Thompson, Larry J

“…The removal of 5 pharmaceuticals from the market in a 12-month period because of unexpected adverse events raised concerns about the adequacy of the drug…”
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FDA public health advisory by Lumpkin, M M

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Modeling outbreak data: Analysis of a 2012 Ebola virus disease epidemic in DRC by Choi, Boseung, Busch, Sydney, Kazadi, Dieudonné, Ilunga, Benoit, Okitolonda, Emile, Dai, Yi, Lumpkin, Robert, Saucedo, Omar, KhudaBukhsh, Wasiur R, Tien, Joseph, Yotebieng, Marcel, Kenah, Eben, Rempala, Grzegorz A

“…We describe two approaches to modeling data from a small to moderate-sized epidemic outbreak. The first approach is based on a branching process approximation…”
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Pandemic Best Regulatory Practices: An Urgent Need in the COVID‐19 Pandemic by Lumpkin, Murray M., Lim, John C. W.

“…As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID‐19) pandemic are being investigated, medicine…”
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Transparency practices at the FDA: A barrier to global health by Lumpkin, Murray M., Hamburg, Margaret A., Schultz, William B., Sharfstein, Joshua M.

“…Data sharing among regulators must be “business as usual” During the COVID-19 pandemic, scientists at the US Food and Drug Administration (FDA) have reviewed…”
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Global regulatory agility during covid-19 and other health emergencies by Mak, Tippi K, Lim, John CW, Thanaphollert, Prapassorn, Mahlangu, Gugu N, Cooke, Emer, Lumpkin, Murray M

“…Enhanced collaboration among authorities is key to ensuring timely access to high quality health products worldwide…”
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Safety alert: hazards of precipitation associated with parenteral nutrition by Lumpkin, M M

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The case for an HIV cure and how to get there by Dybul, Mark, Attoye, Timothy, Baptiste, Solange, Cherutich, Peter, Dabis, François, Deeks, Steven G, Dieffenbach, Carl, Doehle, Brian, Goodenow, Maureen M, Jiang, Adam, Kemps, Dominic, Lewin, Sharon R, Lumpkin, Murray M, Mathae, Lauren, McCune, Joseph M, Ndung'u, Thumbi, Nsubuga, Moses, Peay, Holly L, Pottage, John, Warren, Mitchell, Sikazwe, Izukanji

“…In light of the increasing global burden of new HIV infections, growing financial requirements, and shifting funding landscape, the global health community…”
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Fruit Quality and Bioactive Compounds with Antioxidant Activity of Tomatoes Grown On-Farm: Comparison of Organic and Conventional Management Systems by Juroszek, Peter, Lumpkin, Heidi M, Yang, Ray-Yu, Ledesma, Dolores R, Ma, Chin-Hua

“…Replicated field trials at three matched farm pairs in southern and central Taiwan were established in October 2004 and 2005 to compare fruit quality and…”
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The Pharmacokinetics of Perchlorate and Its Effect on the Hypothalamus–Pituitary–Thyroid Axis in the Male Rat by Yu, Kyung O., Narayanan, Latha, Mattie, David R., Godfrey, Richard J., Todd, Paula N., Sterner, Teresa R., Mahle, Deirdre A., Lumpkin, Michael H., Fisher, Jeffrey W.

“…Perchlorate, an environmental contaminant, is known to disturb the hypothalamus–pituitary–thyroid (HPT) axis by blocking iodide accumulation in the thyroid…”
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The Regulation of ACTH Secretion by IL-1 by Lumpkin, Michael D.

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