Search Results - "Eichler, H"

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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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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"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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Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators by Postmus, D, Mavris, M, Hillege, HL, Salmonson, T, Ryll, B, Plate, A, Moulon, I, Eichler, H-G, Bere, N, Pignatti, F

“…Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and…”
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Asthma severity and medical resource utilisation by Antonicelli, L, Bucca, C, Neri, M, De Benedetto, F, Sabbatani, P, Bonifazi, F, Eichler, H-G, Zhang, Q, Yin, D.D

“…Asthma represents a growing public health problem and the cost of asthma has been rising in many countries. The aim of this study was to estimate the direct…”
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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making by Schneeweiss, S, Eichler, H-G, Garcia-Altes, A, Chinn, C, Eggimann, A-V, Garner, S, Goettsch, W, Lim, R, Löbker, W, Martin, D, Müller, T, Park, BJ, Platt, R, Priddy, S, Ruhl, M, Spooner, A, Vannieuwenhuyse, B, Willke, RJ

“…Analyses of healthcare databases (claims, electronic health records [EHRs]) are useful supplements to clinical trials for generating evidence on the…”
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A randomized trial of safety, pharmacokinetics and pharmacodynamics of concizumab in people with hemophilia A by Eichler, H., Angchaisuksiri, P., Kavakli, K., Knoebl, P., Windyga, J., Jiménez‐Yuste, V., Hyseni, A., Friedrich, U., Chowdary, P.

“…Essentials explorer™3 was a double‐blinded, multiple‐dose escalation trial of subcutaneous concizumab. A pharmacodynamic relationship for unbound TFPI and…”
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Accelerated Access to Innovative Medicines for Patients in Need by Baird, L G, Banken, R, Eichler, H-G, Kristensen, F B, Lee, D K, Lim, J C W, Lim, R, Longson, C, Pezalla, E, Salmonson, T, Samaha, D, Tunis, S, Woodcock, J, Hirsch, G

“…There is broad agreement among health‐care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines…”
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Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan by Oye, KA, Eichler, HG, Hoos, A, Mori, Y, Mullin, TM, Pearson, M

“…This article describes recent developments in licensing and reimbursement policies in the EU, US, and Japan, examines causes of changes and compares…”
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Diagnostic and prognostic value of factor VIII binding antibodies in acquired hemophilia A: data from the GTH‐AH 01/2010 study by Werwitzke, S., Geisen, U., Nowak‐Göttl, U., Eichler, H., Stephan, B., Scholz, U., Holstein, K., Klamroth, R., Knöbl, P., Huth‐Kühne, A., Bomke, B., Tiede, A.

“…Essentials Factor VIII (FVIII) binding IgG detected by ELISA could be an alternative to the Bethesda assay. We studied the performance of anti‐FVIII IgG ELISA…”
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A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials by Selker, H P, Oye, K A, Eichler, H-G, Stockbridge, N L, Mehta, C R, Kaitin, K I, McElwee, N E, Honig, P K, Erban, J K, D'Agostino, R B

“…We propose an “efficacy‐to‐effectiveness” (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the…”
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Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions by Pignatti, F, Ashby, D, Brass, EP, Eichler, H-G, Frey, P, Hillege, HL, Hori, A, Levitan, B, Liberti, L, Löfstedt, RE, McAuslane, N, Micaleff, A, Noel, RA, Postmus, D, Renn, O, Sabourin, BJ, Salmonson, T, Walker, S

“…Structured frameworks for benefit‐risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of…”
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The impact of delayed chemotherapy-induced nausea and vomiting on patients, health resource utilization and costs in German cancer centers by Ihbe-Heffinger, A., Ehlken, B., Bernard, R., Berger, K., Peschel, C., Eichler, H.-G., Deuson, R., Thödtmann, J., Lordick, F.

“…Background: Delayed chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer chemotherapy. We assessed, under current practice…”
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Relative humidity dependence of aerosol optical properties and direct radiative forcing in the surface boundary layer at Xinken in Pearl River Delta of China: An observation based numerical study by Cheng, Y.F., Wiedensohler, A., Eichler, H., Heintzenberg, J., Tesche, M., Ansmann, A., Wendisch, M., Su, H., Althausen, D., Herrmann, H., Gnauk, T., Brüggemann, E., Hu, M., Zhang, Y.H.

“…In a numerical study, influences of relative humidity (RH) on aerosol optical properties and direct radiative forcing in the surface boundary layer at Xinken…”
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Refinement of a Structural Model of a Pigment−Protein Complex by Accurate Optical Line Shape Theory and Experiments by Renger, T, Trostmann, I, Theiss, C, Madjet, M. E, Richter, M, Paulsen, H, Eichler, H. J, Knorr, A, Renger, G

“…Time-local and time-nonlocal theories are used in combination with optical spectroscopy to characterize the water-soluble chlorophyll binding protein complex…”
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Aerosol optical properties and related chemical apportionment at Xinken in Pearl River Delta of China by Cheng, Y.F., Wiedensohler, A., Eichler, H., Su, H., Gnauk, T., Brüggemann, E., Herrmann, H., Heintzenberg, J., Slanina, J., Tuch, T., Hu, M., Zhang, Y.H.

“…Aerosol optical properties (AOPs) of sub- 10 μ m particles under dry conditions (relative humidity (RH) < 20 % ) were investigated at Xinken in Pearl River…”
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Thermally Activated Superradiance and Intersystem Crossing in the Water-Soluble Chlorophyll Binding Protein by Renger, T, Madjet, M. E, Müh, F, Trostmann, I, Schmitt, F.-J, Theiss, C, Paulsen, H, Eichler, H. J, Knorr, A, Renger, G

“…The crystal structure of the class IIb water-soluble chlorophyll binding protein (WSCP) from Lepidium virginicum is used to model linear absorption and…”
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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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European Perspective on Risk Management and Drug Safety by Raine, J, Wise, L, Blackburn, S, Eichler, H‐G, Breckenridge, A

“…Risk management is an approach that has been used for many years in areas of business and government such as finance and insurance, but its use in the…”
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Autologous concentrated platelet-rich plasma (cPRP) for local application in bone regeneration by Dugrillon, A., Eichler, H., Kern, S., Klüter, H.

“…Platelets are rich in growth factors that may contribute to an accelerated tissue regeneration process. The therapeutic osteogenic effect of local platelet…”
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