Detalhe da pesquisa
1.
A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.
Oncologist
; 21(7): 789-94, 2016 07.
Artigo
Inglês
| MEDLINE | ID: mdl-27091420
2.
Healthy donor hematopoietic stem cell mobilization with biosimilar granulocyte-colony-stimulating factor: safety, efficacy, and graft performance.
Transfusion
; 56(12): 3055-3064, 2016 12.
Artigo
Inglês
| MEDLINE | ID: mdl-27633122
3.
Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Future Oncol
; 12(11): 1359-67, 2016 Jun.
Artigo
Inglês
| MEDLINE | ID: mdl-27020170
4.
Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study.
BMC Neurol
; 15: 17, 2015 Feb 28.
Artigo
Inglês
| MEDLINE | ID: mdl-25879416
5.
Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method.
Ther Innov Regul Sci
; 58(3): 415-422, 2024 May.
Artigo
Inglês
| MEDLINE | ID: mdl-38265736
6.
Design and Execution of Sustainable Decentralized Clinical Trials.
Clin Pharmacol Ther
; 114(4): 802-809, 2023 10.
Artigo
Inglês
| MEDLINE | ID: mdl-37489911
7.
Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.
Contemp Clin Trials
; 132: 107292, 2023 09.
Artigo
Inglês
| MEDLINE | ID: mdl-37454729
8.
A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials.
Clin Pharmacol Ther
; 111(5): 1050-1060, 2022 05.
Artigo
Inglês
| MEDLINE | ID: mdl-34762298
9.
Academic outcomes in Asian children aged 8-11 years with attention-deficit/hyperactivity disorder treated with atomoxetine hydrochloride.
Int J Psychiatry Clin Pract
; 15(2): 145-56, 2011 Jun.
Artigo
Inglês
| MEDLINE | ID: mdl-22121863
10.
Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice.
Ther Innov Regul Sci
; 54(2): 324-341, 2020 03.
Artigo
Inglês
| MEDLINE | ID: mdl-32072573
11.
Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.
Ther Innov Regul Sci
; 54(2): 370-384, 2020 03.
Artigo
Inglês
| MEDLINE | ID: mdl-32072586
12.
Correction: Incorporating Prior Data in Quantitative Benefit-Risk Assessments: Case Study of a Bayesian Method.
Ther Innov Regul Sci
; 58(3): 519, 2024 May.
Artigo
Inglês
| MEDLINE | ID: mdl-38345726
13.
Advancing innovative clinical trials to efficiently deliver medicines to patients.
Nat Rev Drug Discov
; 21(8): 543-544, 2022 08.
Artigo
Inglês
| MEDLINE | ID: mdl-35760887
14.
Pharmacokinetics, Safety and Bioequivalence of Levetiracetam Intravenous Infusion and Oral Tablets in Healthy Chinese Subjects.
Clin Drug Investig
; 35(8): 495-503, 2015 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-26135593
15.
Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.
BioDrugs
; 29(2): 123-31, 2015 Apr.
Artigo
Inglês
| MEDLINE | ID: mdl-25837839
16.
Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study.
Expert Opin Pharmacother
; 16(7): 961-70, 2015 May.
Artigo
Inglês
| MEDLINE | ID: mdl-25846031
17.
Association between painful physical symptoms and clinical outcomes in Chinese patients with major depressive disorder: a three-month observational study.
Chin Med J (Engl)
; 123(15): 2063-9, 2010 Aug 05.
Artigo
Inglês
| MEDLINE | ID: mdl-20819543
18.
Factors associated with weight gain during olanzapine treatment in patients with schizophrenia or bipolar disorder: results from a six-month prospective, multinational, observational study.
World J Biol Psychiatry
; 10(4 Pt 3): 729-40, 2009.
Artigo
Inglês
| MEDLINE | ID: mdl-19606406
19.
Association between Painful Physical Symptoms and Clinical Outcomes in Korean Patients with Major Depressive Disorder: A Three-Month Observational Study.
Psychiatry Investig
; 6(4): 255-63, 2009 Dec.
Artigo
Inglês
| MEDLINE | ID: mdl-20140123