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Blood-based systems biology biomarkers for next-generation clinical trials in Alzheimer's disease

Hampel H, Vergallo A, Afshar M, Akman-Anderson L, Arenas J, Benda N, Batrla R, Broich K, Caraci F, Cuello AC, Emanuele E, Haberkamp M, Kiddle SJ, Lucía A, Mapstone M, Verdooner SR, Woodcock J, Lista S.

Dialogues Clin Neurosci. 2019;21(2):177-191.


Drug Regulation in the Era of Individualized Therapies.

Woodcock J, Marks P.

N Engl J Med. 2019 Oct 24;381(17):1678-1680. doi: 10.1056/NEJMe1911295. Epub 2019 Oct 9. No abstract available.


Barriers to investing in cycling: Stakeholder views from England.

Aldred R, Watson T, Lovelace R, Woodcock J.

Transp Res Part A Policy Pract. 2019 Oct;128:149-159. doi: 10.1016/j.tra.2017.11.003.


Improving Adverse Event Reporting for Compounded Drugs.

Dohm J, Kim J, Woodcock J.

JAMA Intern Med. 2019 Sep 9. doi: 10.1001/jamainternmed.2019.3830. [Epub ahead of print] No abstract available.


Using a Benefit Risk Analysis Approach To Capture Regulatory Decision-Making: Renal Cell Carcinoma.

Raju GK, Gurumurthi K, Domike R, Weinstock C, Singh H, Kluetz P, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2019 Jul 29. doi: 10.1002/cpt.1589. [Epub ahead of print]


Driving status, travel modes and accelerometer-assessed physical activity in younger, middle-aged and older adults: a prospective study of 90 810 UK Biobank participants.

Hajna S, White T, Panter J, Brage S, Wijndaele K, Woodcock J, Ogilvie D, Imamura F, Griffin SJ.

Int J Epidemiol. 2019 Aug 1;48(4):1175-1186. doi: 10.1093/ije/dyz065.


Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.

Raju GK, Gurumurthi K, Domike R, Theoret MR, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2019 Jul;106(1):123-135. doi: 10.1002/cpt.1461. Epub 2019 May 21.


I beg to differ.

Woodcock JA.

Br Dent J. 2019 Mar;226(5):306-307. doi: 10.1038/s41415-019-0101-5. No abstract available.


Assessing the exposure-response relationship of sleep disturbance and vibration in field and laboratory settings.

Persson Waye K, Smith MG, Hussain-Alkhateeb L, Koopman A, Ögren M, Peris E, Waddington D, Woodcock J, Sharp C, Janssen S.

Environ Pollut. 2019 Feb;245:558-567. doi: 10.1016/j.envpol.2018.09.082. Epub 2018 Sep 21.


Combined Gabapentinoid and Opioid Use: The Consequences of Shifting Prescribing Trends.

Throckmorton DC, Woodcock J.

Ann Intern Med. 2018 Nov 20;169(10):727-728. doi: 10.7326/M18-2175. Epub 2018 Aug 21. No abstract available.


Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.

Corrigan-Curay J, Sacks L, Woodcock J.

JAMA. 2018 Sep 4;320(9):867-868. doi: 10.1001/jama.2018.10136. No abstract available.


Development of the Impacts of Cycling Tool (ICT): A modelling study and web tool for evaluating health and environmental impacts of cycling uptake.

Woodcock J, Abbas A, Ullrich A, Tainio M, Lovelace R, Sá TH, Westgate K, Goodman A.

PLoS Med. 2018 Jul 31;15(7):e1002622. doi: 10.1371/journal.pmed.1002622. eCollection 2018 Jul.


ARGET-ATRP synthesis and swelling response of compositionally varied poly(methacrylic acid-co-N,N-diethylaminoethyl methacrylate) polyampholyte brushes.

Ramirez R, Woodcock J, Kilbey SM.

Soft Matter. 2018 Aug 1;14(30):6290-6302. doi: 10.1039/c8sm00882e.


Public perception: Dental imaging?

Woodcock JA.

Br Dent J. 2018 Jul 13;225(1):3. doi: 10.1038/sj.bdj.2018.552. No abstract available.


Expediting drug development for serious illness: Trade-offs between patient access and certainty.

Woodcock J.

Clin Trials. 2018 Jun;15(3):230-234. doi: 10.1177/1740774518770656. No abstract available.


The FDA and the Next Wave of Drug Abuse - Proactive Pharmacovigilance.

Throckmorton DC, Gottlieb S, Woodcock J.

N Engl J Med. 2018 Jul 19;379(3):205-207. doi: 10.1056/NEJMp1806486. Epub 2018 May 30. No abstract available.


Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.

Scott PE, Unger EF, Jenkins MR, Southworth MR, McDowell TY, Geller RJ, Elahi M, Temple RJ, Woodcock J.

J Am Coll Cardiol. 2018 May 8;71(18):1960-1969. doi: 10.1016/j.jacc.2018.02.070.


Estimating city-level travel patterns using street imagery: A case study of using Google Street View in Britain.

Goel R, Garcia LMT, Goodman A, Johnson R, Aldred R, Murugesan M, Brage S, Bhalla K, Woodcock J.

PLoS One. 2018 May 2;13(5):e0196521. doi: 10.1371/journal.pone.0196521. eCollection 2018.


Cycling injury risk in London: A case-control study exploring the impact of cycle volumes, motor vehicle volumes, and road characteristics including speed limits.

Aldred R, Goodman A, Gulliver J, Woodcock J.

Accid Anal Prev. 2018 Aug;117:75-84. doi: 10.1016/j.aap.2018.03.003. Epub 2018 Apr 13.


Medication development in opioid addiction: Meaningful clinical end points.

Volkow ND, Woodcock J, Compton WM, Throckmorton DC, Skolnick P, Hertz S, Wargo EM.

Sci Transl Med. 2018 Mar 28;10(434). pii: eaan2595. doi: 10.1126/scitranslmed.aan2595. Review.


Sedentary behaviour and risk of all-cause, cardiovascular and cancer mortality, and incident type 2 diabetes: a systematic review and dose response meta-analysis.

Patterson R, McNamara E, Tainio M, de Sá TH, Smith AD, Sharp SJ, Edwards P, Woodcock J, Brage S, Wijndaele K.

Eur J Epidemiol. 2018 Sep;33(9):811-829. doi: 10.1007/s10654-018-0380-1. Epub 2018 Mar 28. Review.


The FDA's Approach to the Prescription Opioid Problem.

Woodcock J, Throckmorton DC.

Clin Pharmacol Ther. 2018 Jun;103(6):954-955. doi: 10.1002/cpt.1055. Epub 2018 Mar 23.


The current and potential health benefits of the National Health Service Health Check cardiovascular disease prevention programme in England: A microsimulation study.

Mytton OT, Jackson C, Steinacher A, Goodman A, Langenberg C, Griffin S, Wareham N, Woodcock J.

PLoS Med. 2018 Mar 6;15(3):e1002517. doi: 10.1371/journal.pmed.1002517. eCollection 2018 Mar.


Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M.

Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Review.


Precision pharmacology for Alzheimer's disease.

Hampel H, Vergallo A, Aguilar LF, Benda N, Broich K, Cuello AC, Cummings J, Dubois B, Federoff HJ, Fiandaca M, Genthon R, Haberkamp M, Karran E, Mapstone M, Perry G, Schneider LS, Welikovitch LA, Woodcock J, Baldacci F, Lista S; Alzheimer Precision Medicine Initiative (APMI).

Pharmacol Res. 2018 Apr;130:331-365. doi: 10.1016/j.phrs.2018.02.014. Epub 2018 Feb 16. Review.


Meeting Report: The 8th Barossa Meeting-Cell Signaling in Cancer Medicine in the Barossa Valley, Australia.

Gomez GA, Woodcock JM, Tergaonkar V, Gregory PA.

Cell Death Dis. 2018 Feb 15;9(3):284. doi: 10.1038/s41419-018-0285-7. No abstract available.


Toward Better-Quality Compounded Drugs - An Update from the FDA.

Woodcock J, Dohm J.

N Engl J Med. 2017 Dec 28;377(26):2509-2512. doi: 10.1056/NEJMp1712905. No abstract available.


Understanding bicycling in cities using system dynamics modelling.

Macmillan A, Woodcock J.

J Transp Health. 2017 Dec;7(Pt B):269-279. doi: 10.1016/j.jth.2017.08.002.


Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease.

Schuck RN, Pacanowski M, Woodcock J, Zineh I.

Nat Rev Drug Discov. 2018 Feb;17(2):79-80. doi: 10.1038/nrd.2017.231. Epub 2017 Dec 22. No abstract available.


Drug Trials Snapshots and Sexless Drug Labels-Reply.

Whyte J, Woodcock J, Wang J.

JAMA Intern Med. 2017 Dec 1;177(12):1868-1869. doi: 10.1001/jamainternmed.2017.5646. No abstract available.


Contextualising Safety in Numbers: a longitudinal investigation into change in cycling safety in Britain, 1991-2001 and 2001-2011.

Aldred R, Goel R, Woodcock J, Goodman A.

Inj Prev. 2019 Jun;25(3):236-241. doi: 10.1136/injuryprev-2017-042498. Epub 2017 Nov 30.


Role of salt bridges in the dimer interface of 14-3-3ζ in dimer dynamics, N-terminal α-helical order, and molecular chaperone activity.

Woodcock JM, Goodwin KL, Sandow JJ, Coolen C, Perugini MA, Webb AI, Pitson SM, Lopez AF, Carver JA.

J Biol Chem. 2018 Jan 5;293(1):89-99. doi: 10.1074/jbc.M117.801019. Epub 2017 Nov 6.


Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

Mehta MU, Uppoor RS, Conner DP, Seo P, Vaidyanathan J, Volpe DA, Stier E, Chilukuri D, Dorantes A, Ghosh T, Mandula H, Raines K, Dhanormchitphong P, Woodcock J, Yu LX.

Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7.


Phase mask-based multimodal superresolution microscopy.

Beams R, Woodcock JW, Gilman JW, Stranick SJ.

Photonics. 2017;4(3):39. doi: 10.3390/photonics4030039. Epub 2017 Jul 6.


Health and greenhouse gas mitigation benefits of ambitious expansion of cycling, walking, and transit in California.

Maizlish N, Linesch NJ, Woodcock J.

J Transp Health. 2017 Sep;6:490-500. doi: 10.1016/j.jth.2017.04.011.


A shift from motorised travel to active transport: What are the potential health gains for an Australian city?

Zapata-Diomedi B, Knibbs LD, Ware RS, Heesch KC, Tainio M, Woodcock J, Veerman JL.

PLoS One. 2017 Oct 11;12(10):e0184799. doi: 10.1371/journal.pone.0184799. eCollection 2017.


Clinical and pathologic factors associated with deep transection of biopsies of invasive melanoma.

Woodcock JL, Eyre ZW, Stoddard GJ, Callis Duffin K, Bowen AR.

J Am Acad Dermatol. 2017 Oct;77(4):766-768. doi: 10.1016/j.jaad.2017.04.1134. No abstract available.


A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

Raju GK, Gurumurthi K, Domike R, Kazandjian D, Landgren O, Blumenthal GM, Farrell A, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2018 Jan;103(1):67-76. doi: 10.1002/cpt.871. Epub 2017 Nov 20. Review.


Corrigendum: 14-3-3ζ regulates the mitochondrial respiratory reserve linked to platelet phosphatidylserine exposure and procoagulant function.

Schoenwaelder SM, Darbousset R, Cranmer SL, Ramshaw HS, Orive SL, Sturgeon S, Yuan Y, Yao Y, Krycer JR, Woodcock J, Maclean J, Pitson S, Zheng Z, Henstridge DC, van der Wal D, Gardiner EE, Berndt MC, Andrews RK, James DE, Lopez AF, Jackson SP.

Nat Commun. 2017 Aug 30;8:16125. doi: 10.1038/ncomms16125.


Health impact modelling of different travel patterns on physical activity, air pollution and road injuries for São Paulo, Brazil.

Sá TH, Tainio M, Goodman A, Edwards P, Haines A, Gouveia N, Monteiro C, Woodcock J.

Environ Int. 2017 Nov;108:22-31. doi: 10.1016/j.envint.2017.07.009. Epub 2017 Aug 4.


Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data.

Jarow JP, LaVange L, Woodcock J.

JAMA. 2017 Aug 22;318(8):703-704. doi: 10.1001/jama.2017.9991. No abstract available.


Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic.

Gottlieb S, Woodcock J.

JAMA. 2017 Aug 1;318(5):421-422. doi: 10.1001/jama.2017.9205. No abstract available.


Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.

Woodcock J, LaVange LM.

N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. No abstract available.


Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials.

Shapley S, O'Shaughnessy J, Woodcock J.

Ther Innov Regul Sci. 2017 Jul;51(4):416-418. doi: 10.1177/2168479017701801. Epub 2017 Apr 16.


Mortality, greenhouse gas emissions and consumer cost impacts of combined diet and physical activity scenarios: a health impact assessment study.

Tainio M, Monsivais P, Jones NR, Brand C, Woodcock J.

BMJ Open. 2017 Feb 22;7(2):e014199. doi: 10.1136/bmjopen-2016-014199.


Review of the Drug Trials Snapshots Program of the US Food and Drug Administration: Women in Cardiovascular Drug Trials.

Whyte J, Woodcock J, Wang J.

JAMA Intern Med. 2017 May 1;177(5):724-727. doi: 10.1001/jamainternmed.2017.0033. No abstract available.


The modelled impact of increases in physical activity: the effect of both increased survival and reduced incidence of disease.

Mytton OT, Tainio M, Ogilvie D, Panter J, Cobiac L, Woodcock J.

Eur J Epidemiol. 2017 Mar;32(3):235-250. doi: 10.1007/s10654-017-0235-1. Epub 2017 Mar 3.


Value Assessment in the Regulatory Context.

Miller KL, Woodcock J.

Value Health. 2017 Feb;20(2):296-298. doi: 10.1016/j.jval.2016.11.010.


Actinic granuloma presenting as tender, linear plaques on the lateral fingers in a patient with newly diagnosed esophageal cancer.

Michaelis TC, Woodcock JL, Basic KK.

JAAD Case Rep. 2017 Feb 3;3(1):55-57. doi: 10.1016/j.jdcr.2016.11.010. eCollection 2017 Jan. No abstract available.


Cycling provision separated from motor traffic: a systematic review exploring whether stated preferences vary by gender and age.

Aldred R, Elliott B, Woodcock J, Goodman A.

Transp Rev. 2017 Jan 2;37(1):29-55. doi: 10.1080/01441647.2016.1200156. Epub 2016 Jul 14.

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