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Items: 1 to 50 of 85

1.

Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions.

El-Zein M, Bouten S, Louvanto K, Gilbert L, Gotlieb WH, Hemmings R, Behr MA, Franco EL; CASSIS Study Group*.

Cancer Epidemiol Biomarkers Prev. 2019 Jul;28(7):1134-1140. doi: 10.1158/1055-9965.EPI-18-1338. Epub 2019 Apr 23.

PMID:
31015201
3.

Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.

Ollivier C, Thomson A, Manolis E, Blake K, Karlsson KE, Knibbe CAJ, Pons G, Hemmings R.

Br J Clin Pharmacol. 2019 Apr;85(4):659-668. doi: 10.1111/bcp.13883. Epub 2019 Feb 28.

PMID:
30707770
4.

Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.

Collignon O, Koenig F, Koch A, Hemmings RJ, Pétavy F, Saint-Raymond A, Papaluca-Amati M, Posch M.

Trials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x.

5.

Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study.

El-Zein M, Bouten S, Louvanto K, Gilbert L, Gotlieb W, Hemmings R, Behr MA, Franco EL; CASSIS Study Group.

Gynecol Oncol. 2018 Jun;149(3):491-497. doi: 10.1016/j.ygyno.2018.04.004. Epub 2018 Apr 17.

PMID:
29678360
6.

How to use prior knowledge and still give new data a chance?

Weber K, Hemmings R, Koch A.

Pharm Stat. 2018 Jul;17(4):329-341. doi: 10.1002/pst.1862. Epub 2018 Apr 17.

7.

Development of Exon Skipping Therapies for Duchenne Muscular Dystrophy: A Critical Review and a Perspective on the Outstanding Issues.

Aartsma-Rus A, Straub V, Hemmings R, Haas M, Schlosser-Weber G, Stoyanova-Beninska V, Mercuri E, Muntoni F, Sepodes B, Vroom E, Balabanov P.

Nucleic Acid Ther. 2017 Oct;27(5):251-259. doi: 10.1089/nat.2017.0682. Epub 2017 Aug 10. Review.

8.

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).

Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, Posch M, Yates J, Berry S, Thomas N, Corriol-Rohou S, Bornkamp B, Bretz F, Hooker AC, Van der Graaf PH, Standing JF, Hay J, Cole S, Gigante V, Karlsson K, Dumortier T, Benda N, Serone F, Das S, Brochot A, Ehmann F, Hemmings R, Rusten IS.

CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429. doi: 10.1002/psp4.12196. Epub 2017 Jul 19.

9.

Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.

Stefanska AM, Distlerová D, Musaus J, Olski TM, Dunder K, Salmonson T, Mentzer D, Müller-Berghaus J, Hemmings R, Veselý R.

Arch Dis Child. 2017 Oct;102(10):952-957. doi: 10.1136/archdischild-2016-312259. Epub 2017 May 29. Review.

PMID:
28554892
10.

Prise en charge des fibromes utérins en présence d'une infertilité autrement inexpliquée.

Carranza-Mamane B, Havelock J, Hemmings R.

J Obstet Gynaecol Can. 2016 Dec;38(12S):S597-S608. doi: 10.1016/j.jogc.2016.09.066. Epub 2017 Jan 4.

PMID:
28063569
11.

Stakeholder cooperation to overcome challenges in orphan medicine development: the example of Duchenne muscular dystrophy.

Straub V, Balabanov P, Bushby K, Ensini M, Goemans N, De Luca A, Pereda A, Hemmings R, Campion G, Kaye E, Arechavala-Gomeza V, Goyenvalle A, Niks E, Veldhuizen O, Furlong P, Stoyanova-Beninska V, Wood MJ, Johnson A, Mercuri E, Muntoni F, Sepodes B, Haas M, Vroom E, Aartsma-Rus A.

Lancet Neurol. 2016 Jul;15(8):882-890. doi: 10.1016/S1474-4422(16)30035-7. Review.

PMID:
27302365
12.

Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials.

Mehrotra DV, Hemmings RJ, Russek-Cohen E; ICH E9/R1 Expert Working Group.

Clin Trials. 2016 Aug;13(4):456-8. doi: 10.1177/1740774516633115. Epub 2016 Feb 17.

PMID:
26908545
13.

A viewpoint on European Medicines Agency experience with investigational medicinal products for Ebola.

Cavaleri M, Thomson A, Salmonson T, Hemmings RJ.

Clin Trials. 2016 Feb;13(1):101-4. doi: 10.1177/1740774515619860. Epub 2016 Jan 14. No abstract available.

PMID:
26768561
14.

On the need for increased rigour and care in the conduct and interpretation of network meta-analyses in drug development.

Carroll K, Hemmings R.

Pharm Stat. 2016 Mar-Apr;15(2):135-42. doi: 10.1002/pst.1733. Epub 2016 Jan 6. Review.

PMID:
26732132
15.

Identification and validation of biomarkers for autism spectrum disorders.

Loth E, Spooren W, Ham LM, Isaac MB, Auriche-Benichou C, Banaschewski T, Baron-Cohen S, Broich K, Bölte S, Bourgeron T, Charman T, Collier D, de Andres-Trelles F, Durston S, Ecker C, Elferink A, Haberkamp M, Hemmings R, Johnson MH, Jones EJ, Khwaja OS, Lenton S, Mason L, Mantua V, Meyer-Lindenberg A, Lombardo MV, O'Dwyer L, Okamoto K, Pandina GJ, Pani L, Persico AM, Simonoff E, Tauscher-Wisniewski S, Llinares-Garcia J, Vamvakas S, Williams S, Buitelaar JK, Murphy DG.

Nat Rev Drug Discov. 2016 Jan;15(1):70-3. doi: 10.1038/nrd.2015.7. No abstract available.

PMID:
26718285
16.

The management of uterine fibroids in women with otherwise unexplained infertility.

Carranza-Mamane B, Havelock J, Hemmings R; REPRODUCTIVE ENDOCRINOLOGY AND INFERTILITY COMMITTEE; SPECIAL CONTRIBUTOR.

J Obstet Gynaecol Can. 2015 Mar;37(3):277-285. doi: 10.1016/S1701-2163(15)30318-2.

PMID:
26001875
17.

Regulatory watch: Impact of scientific advice from the European Medicines Agency.

Hofer MP, Jakobsson C, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J, Hemmings RJ.

Nat Rev Drug Discov. 2015 May;14(5):302-3. doi: 10.1038/nrd4621. Epub 2015 Apr 17. No abstract available.

PMID:
25881970
18.

The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.

Hanaizi Z, Flores B, Hemmings R, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2015 Mar;20(3):329-34. doi: 10.1634/theoncologist.2014-0073. Epub 2015 Feb 11. Review.

19.

The future is now: model-based clinical trial design for Alzheimer's disease.

Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B; Alzheimer's Disease Neuroimaging Initiative; Coalition Against Major Diseases.

Clin Pharmacol Ther. 2015 Mar;97(3):210-4. doi: 10.1002/cpt.16. Epub 2014 Dec 27.

20.

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.

Elsäßer A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, Papaluca-Amati M, Posch M.

Trials. 2014 Oct 2;15:383. doi: 10.1186/1745-6215-15-383. Review.

21.
22.

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.

Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D.

Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003.

PMID:
24985687
23.

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling M, Papaluca-Amati M, Posch M, Rasi G.

Clin Cancer Res. 2014 Mar 15;20(6):1458-68. doi: 10.1158/1078-0432.CCR-13-1571.

24.
25.

The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for medicinal products for human use.

Gravanis I, Lopez AS, Hemmings RJ, Jiménez JC, Garcia-Carbonero R, Gallego IG, Giménez EV, O'Connor D, Giuliani R, Salmonson T, Pignatti F.

Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21.

26.

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

Manolis E, Rohou S, Hemmings R, Salmonson T, Karlsson M, Milligan PA.

CPT Pharmacometrics Syst Pharmacol. 2013 Feb 27;2:e31. doi: 10.1038/psp.2013.7.

27.

Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims.

Marshall SF, Hemmings R, Josephson F, Karlsson MO, Posch M, Steimer JL.

CPT Pharmacometrics Syst Pharmacol. 2013 Feb 27;2:e27. doi: 10.1038/psp.2013.4. No abstract available.

28.

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK.

Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.

PMID:
23549149
29.

Surgically retrieved spermatozoa versus ejaculated spermatozoa in modified natural IVF-ICSI cycles.

Jamal W, Vélez MP, Zini A, Phillips S, Hemmings R, Kadoch IJ.

Reprod Biomed Online. 2012 Sep;25(3):242-7. doi: 10.1016/j.rbmo.2012.06.003. Epub 2012 Jun 19.

PMID:
22818097
30.

Advanced reproductive age and fertility: no. 269, November 2011.

Kimberly L, Case A, Cheung AP, Sierra S, AlAsiri S, Carranza-Mamane B, Case A, Dwyer C, Graham J, Havelock J, Hemmings R, Lee F, Liu K, Murdock W, Senikas V, Vause TD, Wong BC.

Int J Gynaecol Obstet. 2012 Apr;117(1):95-102.

PMID:
22506284
31.

The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, Shepard T, Abadie E, Pignatti F.

Oncologist. 2012;17(4):543-9. doi: 10.1634/theoncologist.2011-0364. Epub 2012 Apr 3. Review.

32.

The diagnosis and management of ovarian hyperstimulation syndrome: No. 268, November 2011.

Joint Society of Obstetricians and Gynaecologists of Canada-Canadian Fertility and Andrology Society Clinical Practice Guidelines Committee, Shmorgun D, Claman P, Gysler M, Hemmings R, Cheung AP, Goodrow GJ, Hughes EG, Min JK, Roberts J, Senikas V, Wong BC, Young DC.

Int J Gynaecol Obstet. 2012 Mar;116(3):268-73.

PMID:
22416285
33.

Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?

Pignatti F, Hemmings R, Jonsson B.

Eur J Cancer. 2011 Aug;47(12):1759-62. doi: 10.1016/j.ejca.2011.05.009. No abstract available.

PMID:
21641204
34.

Efficacy of black cohosh-containing preparations on menopausal symptoms: a meta-analysis.

Shams T, Setia MS, Hemmings R, McCusker J, Sewitch M, Ciampi A.

Altern Ther Health Med. 2010 Jan-Feb;16(1):36-44. Review.

PMID:
20085176
35.

Successful pregnancy in an ovarian agenesis patient after modified natural cycle IVF oocyte donation.

Kadoch IJ, Jamal W, Phillips SJ, Hemmings R, Lapensée L, Couturier B, Bissonnette F.

Reprod Biomed Online. 2009 Aug;19(2):221-3.

PMID:
19712558
36.

Successful pregnancy following novel IVF protocol and transmyometrial embryo transfer after radical vaginal trachelectomy.

Jamal W, Phillips SJ, Hemmings R, Lapensée L, Couturier B, Bissonnette F, Kadoch IJ.

Reprod Biomed Online. 2009 May;18(5):700-3.

PMID:
19549451
37.

Profile of the rural allied health workforce in northern New South Wales and comparison with previous studies.

Smith T, Cooper R, Brown L, Hemmings R, Greaves J.

Aust J Rural Health. 2008 Jun;16(3):156-63. doi: 10.1111/j.1440-1584.2008.00966.x.

PMID:
18471186
38.

Assessing the impact of ICH E9.

Brown D, Day S, Hemmings R, Wright D.

Pharm Stat. 2008 Apr-Jun;7(2):77-87. doi: 10.1002/pst.337.

PMID:
18438957
39.

Spontaneous ovulation rate before oocyte retrieval in modified natural cycle IVF with and without indomethacin.

Kadoch IJ, Al-Khaduri M, Phillips SJ, Lapensée L, Couturier B, Hemmings R, Bissonnette F.

Reprod Biomed Online. 2008 Feb;16(2):245-9.

PMID:
18284881
40.

Discussion of "The White Paper of the PhRMA Working Group on adaptive dose-ranging designs".

Hemmings R.

J Biopharm Stat. 2007;17(6):1021-7; discussion 1029-32. No abstract available.

PMID:
18027213
41.

Conditional approval: discussion points from the PSI conditional approval expert group.

Carroll K, Ross HC, Evans D, France L, Hemmings R, Hughes S, Lynn F, Mahoney P, Phillips A.

Pharm Stat. 2008 Oct-Dec;7(4):263-9; discussion 270-1.

PMID:
17847030
42.

Controlled natural cycle IVF: experience in a world of stimulation.

Phillips SJ, Kadoch IJ, Lapensée L, Couturier B, Hemmings R, Bissonnette F.

Reprod Biomed Online. 2007 Mar;14(3):356-9.

PMID:
17359592
43.

"The blameless physician": narrative and pain, Sassoon and Rivers.

Hemmings R.

Lit Med. 2005 Spring;24(1):109-26. No abstract available.

PMID:
16134839
44.

Ongoing pregnancy after ICSI of frozen-thawed PESA-retrieved spermatozoa and IVF in a controlled natural cycle.

Kadoch IJ, Phillips SJ, Hemmings R, Lapensée L, Couturier B, Bissonnette F.

Reprod Biomed Online. 2005 May;10(5):650-2.

PMID:
15949225
45.

Antisepsis for abdominal hysterectomy: a randomised controlled trial of povidone-iodine gel.

Eason E, Wells G, Garber G, Hemmings R, Luskey G, Gillett P, Martin M; Vaginal Antisepsis For Abdominal Hysterectomy Study Group.

BJOG. 2004 Jul;111(7):695-9.

46.

Evaluation of risk factors associated with endometriosis.

Hemmings R, Rivard M, Olive DL, Poliquin-Fleury J, Gagné D, Hugo P, Gosselin D.

Fertil Steril. 2004 Jun;81(6):1513-21.

PMID:
15193470
47.
48.

Effects of functional ovarian cysts detected on the 7th day of gonadotropin-releasing hormone analog administration on the outcome of IVF treatment.

Biljan MM, Lapensée L, Mahutte NG, Bissonnette F, Hemmings R, Tan SL.

Fertil Steril. 2000 Nov;74(5):941-5.

PMID:
11056237
49.

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