Pharmaceutical Product Development (United States)

Recent papers from Pharmaceutical Product Development (United States)

1. Nonclinical Safety Assessment of SBT777101, a CAR-Engineered Regulatory T Cell Therapy for Autoimmune DiseasesToxicological Sciences · 2026
2. Optimizing high-drug-loaded spray-dried antibody fragment formulations for sustained delivery: influence of excipient composition and humidity on long-term stabilityAAPS Open · 2026
3. Efficacy and safety of a 4-month quabodepistat, delamanid, and bedaquiline regimen for drug-susceptible pulmonary tuberculosis: a multicentre, open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trialThe Lancet Infectious Diseases · 2026
4. AI-driven spatial analysis of tumor-infiltrating lymphocytes predicts chemo-immunotherapy response in triple-negative breast cancerSHILAP Revista de lepidopterología · 2026
5. Multi-stakeholder use of patient experience data (PED): current state and future opportunities for the application of PED to inform decision-makingJournal of Patient-Reported Outcomes · 2026
6. Fab–Fc and Fab–Fab interactions of variable strength and valency contribute to the high concentration viscosity of IgG ₁ antibodiesProceedings of the National Academy of Sciences · 2026
7. A proteomics and redox proteomics approach to understanding ARDS heterogeneityScientific Reports · 2026
8. Conceptualising the experience of having TB: a global qualitative studyIJTLD OPEN · 2026
9. Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trialsnpj Digital Medicine · 2025
10. Defining score interpretation thresholds for clinical outcome assessments: a review of terminology and reporting recommendationsJournal of Patient-Reported Outcomes · 2025
11. Defining score interpretation thresholds for clinical outcome assessments: a review of terminology and reporting recommendationsJournal of Patient-Reported Outcomes · 2025
12. Measuring neurofilament light in human plasma and cerebrospinal fluid: a comparison of five analytical immunoassaysClinical Chemistry and Laboratory Medicine (CCLM) · 2025
13. Qualitative Analysis and Comparison of Externally Led Patient-Focused Drug Development Concepts for Autosomal Recessive Polycystic Kidney Disease Against SONG InitiativesKidney Medicine · 2025
14. Modeling Power Consumption: A Novel Correlation for Stirred Media Mills with Variable Bead Filling RatiosDeleted Journal · 2025
15. Role of serotonin in the neurobiology of attention-deficit/hyperactivity disorder: a systematic literature reviewExpert Opinion on Therapeutic Targets · 2025
16. Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial.2025
17. Combination of Hydroxypropyl-Beta-Cyclodextrin and Trehalose for Improved Stability of Spray-Dried Monoclonal AntibodiesMolecular Pharmaceutics · 2025
18. Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical TrialJournal of the American Academy of Child & Adolescent Psychiatry · 2025
19. Efficacy and Safety of Centanafadine for ADHD Treatment in Children: A Randomized Clinical TrialPediatrics Open Science · 2025
20. Predictive stability in biopharmaceuticals and vaccines: Perspectives and recommendations towards accelerating patient accessJournal of Pharmaceutical Sciences · 2025