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1.
A prospective proof-of-concept trial on the effect of personalized dosages of follitropin delta in intrauterine insemination.
Reprod Biomed Online
; 48(4): 103603, 2024 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-38359732
2.
End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?
Future Oncol
; : 1-15, 2024 Jun 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-38889345
3.
Dual staining for p16/Ki-67 to detect high-grade cervical lesions: Results from the Screening Triage Ascertaining Intraepithelial Neoplasia by Immunostain Testing study.
Int J Cancer
; 148(2): 492-501, 2021 01 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-32781481
4.
Genome-wide DNA methylation profiling identifies two novel genes in cervical neoplasia.
Int J Cancer
; 147(5): 1264-1274, 2020 09 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31983058
5.
EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.
Oncologist
; 25(9): e1414-e1420, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32282100
6.
Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.
Br J Clin Pharmacol
; 85(4): 659-668, 2019 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-30707770
7.
Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study.
Gynecol Oncol
; 149(3): 491-497, 2018 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-29678360
8.
Seeking harmony: estimands and sensitivity analyses for confirmatory clinical trials.
Clin Trials
; 13(4): 456-8, 2016 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-26908545
9.
Prise en charge des fibromes utérins en présence d'une infertilité autrement inexpliquée.
J Obstet Gynaecol Can
; 38(12S): S597-S608, 2016 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-28063569
10.
On the need for increased rigour and care in the conduct and interpretation of network meta-analyses in drug development.
Pharm Stat
; 15(2): 135-42, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-26732132
11.
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.
Oncologist
; 20(3): 329-34, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25673103
12.
The management of uterine fibroids in women with otherwise unexplained infertility.
J Obstet Gynaecol Can
; 37(3): 277-285, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-26001875
13.
An overview of statistical and regulatory issues in the planning, analysis, and interpretation of subgroup analyses in confirmatory clinical trials.
J Biopharm Stat
; 24(1): 4-18, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-24392975
14.
Commentary on: Subgroup analysis and interpretation for phase 3 confirmatory trials: White Paper of the EFSPI/PSI working group on subgroup analysis by Dane, Spencer, Rosenkranz, Lipkovich, and Parke.
Pharm Stat
; 18(2): 140-144, 2019 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-30900391
15.
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
Alzheimers Dement
; 10(4): 421-429.e3, 2014 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-24985687
16.
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework.
Ther Innov Regul Sci
; 58(3): 495-504, 2024 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-38315407
17.
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.
Oncologist
; 18(9): 1032-42, 2013.
Artículo
en Inglés
| MEDLINE | ID: mdl-23966222
18.
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.
Oncologist
; 17(4): 543-9, 2012.
Artículo
en Inglés
| MEDLINE | ID: mdl-22477727
19.
Surgically retrieved spermatozoa versus ejaculated spermatozoa in modified natural IVF-ICSI cycles.
Reprod Biomed Online
; 25(3): 242-7, 2012 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-22818097
20.
Perspectives on Virtual (Remote) Clinical Trials as the "New Normal" to Accelerate Drug Development.
Clin Pharmacol Ther
; 111(2): 373-381, 2022 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-33792920