Detalhe da pesquisa
1.
Safety and effectiveness of Omnitrope® (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data.
Eur J Pediatr
; 181(6): 2367-2378, 2022 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-35275291
2.
No increased risk of glucose metabolism disorders in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope®): data from an observational, longitudinal study.
BMC Endocr Disord
; 19(1): 138, 2019 Dec 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-31829160
3.
Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study.
Drug Des Devel Ther
; 18: 667-684, 2024.
Artigo
em Inglês
| MEDLINE | ID: mdl-38454934
4.
Epoetin alfa biosimilar (HX575): A review of 15 years' post-approval clinical experience.
Crit Rev Oncol Hematol
; 181: 103894, 2023 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-36481307
5.
Early access provision: Awareness, educational needs and opportunities to improve oncology patients' access to care.
Front Oncol
; 12: 714516, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-36387084
6.
Value of Adaptive Trials and Surrogate Endpoints for Clinical Decision-Making in Rare Cancers.
Front Oncol
; 11: 636561, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33763370
7.
PATRO children, a multi-center, non-interventional study of the safety and effectiveness of Omnitrope® (somatropin) treatment in children: update on the United States cohort.
J Pediatr Endocrinol Metab
; 34(4): 431-440, 2021 Apr 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-33647196
8.
Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs.
Expert Opin Drug Saf
; 19(12): 1539-1548, 2020 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-33089723
9.
Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope®): data from the PATRO Adults study.
Ther Adv Endocrinol Metab
; 11: 2042018820943377, 2020.
Artigo
em Inglês
| MEDLINE | ID: mdl-32973992
10.
Ten years of biosimilars in Europe: development and evolution of the regulatory pathways.
Drug Des Devel Ther
; 11: 1509-1515, 2017.
Artigo
em Inglês
| MEDLINE | ID: mdl-28553082
11.
Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data.
Drug Des Devel Ther
; 11: 1489-1495, 2017.
Artigo
em Inglês
| MEDLINE | ID: mdl-28553079
12.
Ten years of clinical experience with biosimilar human growth hormone: a review of safety data.
Drug Des Devel Ther
; 11: 1497-1503, 2017.
Artigo
em Inglês
| MEDLINE | ID: mdl-28553080
13.
Acceptance of a reusable self-injection device for recombinant human growth hormone: final data from a questionnaire-based, cross-sectional, international, multicenter, observational study in pediatric patients.
Med Devices (Auckl)
; 9: 317-24, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27660496
14.
Acceptability of the reusable SurePal™ self-injection device for Omnitrope(®) among pediatric patients: results from a questionnaire-based, cross-sectional, multicenter observational study.
Med Devices (Auckl)
; 8: 389-93, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26405430
15.
Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study.
Med Devices (Auckl)
; 6: 141-6, 2013.
Artigo
em Inglês
| MEDLINE | ID: mdl-24039458
16.
Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) in children requiring growth hormone treatment.
Ther Adv Endocrinol Metab
; 4(1): 3-11, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-23515245
17.
Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency.
Ther Adv Endocrinol Metab
; 3(3): 85-91, 2012 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-23148199
18.
Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data.
Biol Ther
; 1: 5, 2011.
Artigo
em Inglês
| MEDLINE | ID: mdl-24392295
19.
Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis.
J Clin Pharmacol
; 50(11): 1339-48, 2010 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-20173088