46 results on '"Gamalo, Margaret"'
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2. Extent of Safety Database in Pediatric Drug Development: Types of Assessment, Analytical Precision, and Pathway for Extrapolation through On-Target Effects
3. Composite Likelihoods with Bounded Weights in Extrapolation of Data
4. Overview of the Current Real-World Evidence Regulatory Landscape
5. Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics
6. Extrapolation as a Default Strategy in Pediatric Drug Development
7. Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies
8. Simultaneous Confidence Intervals for Signal Detection and Ascertaining Precision of Adverse Event Rates in Clinical Trials.
9. Skin-lightening products (SLPs) and levels of depression, anxiety, and stress among Filipino emerging adults: a cross-sectional study
10. A comprehensive review and shiny application on the matching‐adjusted indirect comparison
11. Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study
12. Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)
13. An analysis of inter-rater and intra-rater Facial Vitiligo Area Scoring Index assessments in adults with active non-segmental vitiligo
14. Innovation in Statistics and Regulatory Science Through Collaboration: A Journey.
15. Association between Body Appreciation and Depression, Anxiety, and Stress among Filipino Emerging Adults: Modification by Age and Sex at Birth.
16. Pediatric needs should be considered early in the clinical development lifecycle
17. Pediatric Age Groups and Approach to Studies
18. Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.
19. Composite Likelihoods with Bounded Weights in Extrapolation of Data.
20. Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.
21. Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges.
22. A win ratio approach for comparing crossing survival curves in clinical trials
23. Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges
24. Strategies to facilitate adolescent access to medicines: Improving regulatory guidance
25. An analysis of inter- and intra-rater Facial Vitiligo Area Scoring Index assessments in adults with active nonsegmental vitiligo.
26. Matching within a hybrid RCT/RWD: framework on associated causal estimands
27. 130 Grownish: how and when to include adolescents in adult research
28. Matching within a hybrid RCT/RWD: framework on associated causal estimands.
29. Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials.
30. Win ratio approach for analyzing composite time‐to‐event endpoint with opposite treatment effects in its components
31. Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.
32. sj-pdf-1-ctj-10.1177_17407745221132302 – Supplemental material for Strategies to facilitate adolescent access to medicines: Improving regulatory guidance
33. sj-pdf-2-ctj-10.1177_17407745221132302 – Supplemental material for Strategies to facilitate adolescent access to medicines: Improving regulatory guidance
34. Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials
35. Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials
36. Bigger and bigger circles - the expanding biopharmaceutical statistician’s toolbox
37. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis
38. Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes
39. Networked knowledge, combinatorial creativity, and (statistical) innovation
40. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis:A Randomized Clinical Trial
41. A year in review: artificial intelligence permeates into mainstream statistics in pharmaceutical product development at a laggard pace
42. 15054 Impact of baricitinib on patient-reported skin symptoms, itch, and quality of life in adult patients with moderate to severe atopic dermatitis and an inadequate response to topical therapies from phase 3 trials BREEZE-AD1 and BREEZE-AD2
43. Discrete Time Multistate Model With Regime Switching for Modeling COVID-19 Disease Progression and Clinical Outcomes.
44. Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics.
45. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study
46. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.
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