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1.

Effects of Food on Bioavailability of Analgesics; Resulting Dosage and Administration Recommendations.

Naraharisetti, Suresh Babu; Srour, Salma; Xu, Yun; Lee, David J; Hertz, Sharon H; Sahajwalla, Chandrahas.

Pain Med; 21(11): 2877-2892, 2020 11 01.

Artículo en Inglés | MEDLINE | ID: mdl-32274507

2.

Anesthetic neurotoxicity--clinical implications of animal models.

Rappaport, Bob A; Suresh, Santhanam; Hertz, Sharon; Evers, Alex S; Orser, Beverley A.

N Engl J Med; 372(9): 796-7, 2015 Feb 26.

Artículo en Inglés | MEDLINE | ID: mdl-25714157

3.

Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement.

Hohenschurz-Schmidt, David J; Cherkin, Dan; Rice, Andrew S C; Dworkin, Robert H; Turk, Dennis C; McDermott, Michael P; Bair, Matthew J; DeBar, Lynn L; Edwards, Robert R; Farrar, John T; Kerns, Robert D; Markman, John D; Rowbotham, Michael C; Sherman, Karen J; Wasan, Ajay D; Cowan, Penney; Desjardins, Paul; Ferguson, McKenzie; Freeman, Roy; Gewandter, Jennifer S; Gilron, Ian; Grol-Prokopczyk, Hanna; Hertz, Sharon H; Iyengar, Smriti; Kamp, Cornelia; Karp, Barbara I; Kleykamp, Bethea A; Loeser, John D; Mackey, Sean; Malamut, Richard; McNicol, Ewan; Patel, Kushang V; Sandbrink, Friedhelm; Schmader, Kenneth; Simon, Lee; Steiner, Deborah J; Veasley, Christin; Vollert, Jan.

Pain; 164(7): 1457-1472, 2023 Jul 01.

Artículo en Inglés | MEDLINE | ID: mdl-36943273

4.

The GAS trial.

Orser, Beverley A; Evers, Alex S; Suresh, Santhanam; Hertz, Sharon.

Lancet; 387(10028): 1613-4, 2016 Apr 16.

Artículo en Inglés | MEDLINE | ID: mdl-27116066

5.

Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

Gewandter, Jennifer S; Smith, Shannon M; Dworkin, Robert H; Turk, Dennis C; Gan, Tong J; Gilron, Ian; Hertz, Sharon; Katz, Nathaniel P; Markman, John D; Raja, Srinivasa N; Rowbotham, Michael C; Stacey, Brett R; Strain, Eric C; Ward, Denham S; Farrar, John T; Kroenke, Kurt; Rathmell, James P; Rauck, Richard; Brown, Colville; Cowan, Penney; Edwards, Robert R; Eisenach, James C; Ferguson, McKenzie; Freeman, Roy; Gray, Roy; Giblin, Kathryn; Grol-Prokopczyk, Hanna; Haythornthwaite, Jennifer; Jamison, Robert N; Martel, Marc; McNicol, Ewan; L Oshinsky, Michael; Sandbrink, Friedhelm; Scholz, Joachim; Scranton, Richard; Simon, Lee S; Steiner, Deborah; Verburg, Kenneth; Wasan, Ajay D; Wentworth, Kerry.

Pain; 162(11): 2669-2681, 2021 11 01.

Artículo en Inglés | MEDLINE | ID: mdl-33863862

6.

Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

Dworkin, Robert H; Turk, Dennis C; Wyrwich, Kathleen W; Beaton, Dorcas; Cleeland, Charles S; Farrar, John T; Haythornthwaite, Jennifer A; Jensen, Mark P; Kerns, Robert D; Ader, Deborah N; Brandenburg, Nancy; Burke, Laurie B; Cella, David; Chandler, Julie; Cowan, Penny; Dimitrova, Rozalina; Dionne, Raymond; Hertz, Sharon; Jadad, Alejandro R; Katz, Nathaniel P; Kehlet, Henrik; Kramer, Lynn D; Manning, Donald C; McCormick, Cynthia; McDermott, Michael P; McQuay, Henry J; Patel, Sanjay; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Revicki, Dennis A; Rothman, Margaret; Schmader, Kenneth E; Stacey, Brett R; Stauffer, Joseph W; von Stein, Thorsten; White, Richard E; Witter, James; Zavisic, Stojan.

J Pain; 9(2): 105-21, 2008 Feb.

Artículo en Inglés | MEDLINE | ID: mdl-18055266

7.

Medication development in opioid addiction: Meaningful clinical end points.

Volkow, Nora D; Woodcock, Janet; Compton, Wilson M; Throckmorton, Douglas C; Skolnick, Phil; Hertz, Sharon; Wargo, Eric M.

Sci Transl Med; 10(434)2018 03 28.

Artículo en Inglés | MEDLINE | ID: mdl-29593105

8.

Patient-Reported Chronic Pain Intensity: More Than Meets the Eye.

Langford, Dale J; Gewandter, Jennifer S; Amtmann, Dagmar; Reeve, Bryce B; Hertz, Sharon; Loeser, John D; Veasley, Christin; Turk, Dennis C; Dworkin, Robert H.

Patient; 15(4): 383-387, 2022 07.

Artículo en Inglés | MEDLINE | ID: mdl-35676465

9.

FDA Experience With Regulation of Naloxone Products to Address the Opioid Crisis and Opportunities for Leveraging Scientific Engagement.

Amur, Shashi; Xu, Yun; Hertz, Sharon; Clingman, Chekesha.

Clin Pharmacol Ther; 109(3): 569-572, 2021 03.

Artículo en Inglés | MEDLINE | ID: mdl-33241562

10.

US Food and Drug Administration Efforts to Support Pain Management and Opioid Access to Patients With Cancer.

Hertz, Sharon H; Throckmorton, Douglas C.

J Oncol Pract; 15(5): 233-234, 2019 05.

Artículo en Inglés | MEDLINE | ID: mdl-31013179

11.

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H.

Pain; 155(11): 2253-62, 2014 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-25123543

12.

Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations.

Gewandter, Jennifer S; Smith, Shannon M; McKeown, Andrew; Burke, Laurie B; Hertz, Sharon H; Hunsinger, Matthew; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Williams, Mark R; Turk, Dennis C; Dworkin, Robert H.

Pain; 155(3): 461-466, 2014 Mar.

Artículo en Inglés | MEDLINE | ID: mdl-24275257

13.

The ACTTION-American Pain Society Pain Taxonomy (AAPT): an evidence-based and multidimensional approach to classifying chronic pain conditions.

Fillingim, Roger B; Bruehl, Stephen; Dworkin, Robert H; Dworkin, Samuel F; Loeser, John D; Turk, Dennis C; Widerstrom-Noga, Eva; Arnold, Lesley; Bennett, Robert; Edwards, Robert R; Freeman, Roy; Gewandter, Jennifer; Hertz, Sharon; Hochberg, Marc; Krane, Elliot; Mantyh, Patrick W; Markman, John; Neogi, Tuhina; Ohrbach, Richard; Paice, Judith A; Porreca, Frank; Rappaport, Bob A; Smith, Shannon M; Smith, Thomas J; Sullivan, Mark D; Verne, G Nicholas; Wasan, Ajay D; Wesselmann, Ursula.

J Pain; 15(3): 241-9, 2014 Mar.

Artículo en Inglés | MEDLINE | ID: mdl-24581634

14.

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations.

Smith, Shannon M; Wang, Anthony T; Katz, Nathaniel P; McDermott, Michael P; Burke, Laurie B; Coplan, Paul; Gilron, Ian; Hertz, Sharon H; Lin, Allison H; Rappaport, Bob A; Rowbotham, Michael C; Sampaio, Cristina; Sweeney, Michael; Turk, Dennis C; Dworkin, Robert H.

Pain; 154(7): 997-1008, 2013 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-23602344

15.

Discrepancies between registered and published primary outcome specifications in analgesic trials: ACTTION systematic review and recommendations.

Smith, Shannon M; Wang, Anthony T; Pereira, Anthony; Chang, Daniel R; McKeown, Andrew; Greene, Kaitlin; Rowbotham, Michael C; Burke, Laurie B; Coplan, Paul; Gilron, Ian; Hertz, Sharon H; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Papadopoulos, Elektra J; Rappaport, Bob A; Sweeney, Michael; Turk, Dennis C; Dworkin, Robert H.

Pain; 154(12): 2769-2774, 2013 Dec.

Artículo en Inglés | MEDLINE | ID: mdl-23962590

16.

Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations.

O'Connor, Alec B; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Colucci, Robert; Haythornthwaite, Jennifer A; Klein, Michael; O'Brien, Charles; Posner, Kelly; Rappaport, Bob A; Reisfield, Gary; Adams, Edgar H; Balster, Robert L; Bigelow, George E; Burke, Laurie B; Comer, Sandra D; Cone, Edward; Cowan, Penney; Denisco, Richard A; Farrar, John T; Foltin, Richard W; Haddox, David J; Hertz, Sharon; Jay, Gary W; Junor, Roderick; Kopecky, Ernest A; Leiderman, Deborah B; McDermott, Michael P; Palmer, Pamela P; Raja, Srinivasa N; Rauschkolb, Christine; Rowbotham, Michael C; Sampaio, Cristina; Setnik, Beatrice; Smith, Shannon M; Sokolowska, Marta; Stauffer, Joseph W; Walsh, Sharon L; Zacny, James P.

Pain; 154(11): 2324-2334, 2013 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-24148704

17.

Regulatory review of acetaminophen clinical pharmacology in young pediatric patients.

Ji, Ping; Wang, Yaning; Li, Zhihong; Doddapaneni, Suresh; Hertz, Sharon; Furness, Scott; Sahajwalla, Chandrahas G.

J Pharm Sci; 101(12): 4383-9, 2012 Dec.

Artículo en Inglés | MEDLINE | ID: mdl-23073837

18.

Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations.

Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Burke, Laurie B; Farrar, John T; Gilron, Ian; Jensen, Mark P; Katz, Nathaniel P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Backonja, Misha-Miroslav; Baron, Ralf; Bellamy, Nicholas; Bhagwagar, Zubin; Costello, Ann; Cowan, Penney; Fang, Weikai Christopher; Hertz, Sharon; Jay, Gary W; Junor, Roderick; Kerns, Robert D; Kerwin, Rosemary; Kopecky, Ernest A; Lissin, Dmitri; Malamut, Richard; Markman, John D; McDermott, Michael P; Munera, Catherine; Porter, Linda; Rauschkolb, Christine; Rice, Andrew S C; Sampaio, Cristina; Skljarevski, Vladimir; Sommerville, Kenneth; Stacey, Brett R; Steigerwald, Ilona; Tobias, Jeffrey; Trentacosti, Ann Marie; Wasan, Ajay D; Wells, George A; Williams, Jim; Witter, James; Ziegler, Dan.

Pain; 153(6): 1148-1158, 2012 Jun.

Artículo en Inglés | MEDLINE | ID: mdl-22494920

19.

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations.

Comer, Sandra D; Zacny, James P; Dworkin, Robert H; Turk, Dennis C; Bigelow, George E; Foltin, Richard W; Jasinski, Donald R; Sellers, Edward M; Adams, Edgar H; Balster, Robert; Burke, Laurie B; Cerny, Igor; Colucci, Robert D; Cone, Edward; Cowan, Penney; Farrar, John T; Haddox, David J; Haythornthwaite, Jennifer A; Hertz, Sharon; Jay, Gary W; Johanson, Chris-Ellyn; Junor, Roderick; Katz, Nathaniel P; Klein, Michael; Kopecky, Ernest A; Leiderman, Deborah B; McDermott, Michael P; O'Brien, Charles; O'Connor, Alec B; Palmer, Pamela P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Rowbotham, Michael C; Sampaio, Cristina; Setnik, Beatrice; Sokolowska, Marta; Stauffer, Joseph W; Walsh, Sharon L.

Pain; 153(12): 2315-2324, 2012 Dec.

Artículo en Inglés | MEDLINE | ID: mdl-22998781

20.

Pediatric drug development in anesthesiology: an FDA perspective.

Schultheis, Lex W; Mathis, Lisa L; Roca, Rigoberto A; Simone, Arthur F; Hertz, Sharon H; Rappaport, Bob A.

Anesth Analg; 103(1): 49-51, 2006 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-16790624

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