Towards a seamless product and process development workflow for recombinant proteins produced by plant molecular farming

JF Buyel - Biotechnology Advances, 2024 - Elsevier
Plant molecular farming (PMF) has been promoted as a fast, efficient and cost-effective
alternative to bacteria and animal cells for the production of biopharmaceutical proteins …

Drug repurposing for glomerular diseases: an underutilized resource

MSY Ng, G Kaur, RS Francis, CM Hawley… - Nature Reviews …, 2024 - nature.com
Drug repurposing in glomerular disease can deliver opportunities for steroid-free regimens,
enable personalized multi-target options for resistant or relapsing disease and enhance …

Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation

AM Hopkins, ND Modi, FW Rockhold… - Journal of Clinical …, 2024 - Elsevier
Abstract Objectives Clinical study reports (CSRs) are highly detailed documents that play a
pivotal role in medicine approval processes. Though not historically publicly available, in …

Journal requirement for data sharing statements in clinical trials: a cross-sectional study

J Zhang, Y Liu, L Thabane, J Li, X Bai, L Li… - Journal of Clinical …, 2024 - Elsevier
Abstracts Objective Data sharing statements are considered routine in clinical trial reporting,
and represent a step towards data transparency. The International Committee of Medical …

The optimal second-line therapy for older adults with type 2 diabetes mellitus: protocol for a systematic review and network meta-analysis using individual participant …

J Wang, K Nirantharakumar, C Sainsbury, DJ Moore… - Systematic …, 2024 - Springer
Background Due to increasing life expectancy, almost half of people with type 2 diabetes are
aged 65 years or over worldwide. When metformin alone does not control blood sugar, the …

The state of individual participant data sharing for the highest-revenue medicines

ND Modi, LX Li, JM Logan, MD Wiese… - Clinical …, 2024 - journals.sagepub.com
Background Amid growing emphasis from pharmaceutical companies, advocacy groups,
and regulatory bodies for sharing of individual participant data, recent audits reveal limited …

Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration-Approved Anticancer Drugs: A Call for Systematic Data …

ND Modi, SM Swain, M Buyse, NM Kuderer… - Journal of Clinical …, 2024 - europepmc.org
Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing
can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic …

Drug Promotions Between Ethics, Regulations, and Financial Interests

V Astărăstoae, LM Rogozea, FG Leaşu… - American Journal of …, 2024 - journals.lww.com
Background: The promotion of the latest medicines produced by the pharmaceutical industry
is an important issue both from an ethical point of view (the level of accessibility, the way …

Meta-Analysis Methods for Neoadjuvant Chemoimmunotherapy for Non–Small Cell Lung Cancer—Reply

M Sorin, C Prosty, JD Spicer - JAMA oncology - jamanetwork.com
In Reply We thank Zhang and colleagues for their appraisal of our work. 1 Regarding the
first point, it appears that the authors have misinterpreted our statistical analysis. The authors …

[HTML][HTML] Gesundheit–gemeinsam. Kooperationstagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Deutschen …

RS Peter, A Nieters, S Göpel, U Merle, J Steinacker… - egms.de
Methods: PCS cases or controls were invited for a comprehensive outpatient clinical
assessment. PCS cases were defined as no more than 80% recovery of general health or …