Seneca Polytechnic

Recent papers from Seneca Polytechnic

1. Renally Cleared Drugs: ADMET Fundamentals, Dose Adjustment in Renal Impairment, and Their Role in Clinical Pharmacokinetics and Toxicology2026
2. Integrating CMC, Nonclinical, and Clinical Evidence Into One eCTD IND for a Next-Generation mRNA-Lipid Nanoparticle Vaccine2026
3. Integrated Summary of Safety and Efficacy Strategy (ISS and ISE) Across Heterogeneous Trial Populations in Oral Factor Xa Anticoagulant Development2026
4. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for B-Cell Activating Factor and APRIL-Targeted Biologics in IgA Nephropathy2026
5. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for Menin Inhibitors in KMT2A-Rearranged Acute Leukemia2026
6. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for Once-Weekly Basal Insulin Analogues in Type 2 Diabetes2026
7. Antibody-Drug Conjugates: ADMET Fundamentals, Multi-Analyte Pharmacokinetic Characterization, and Their Role in Clinical Pharmacokinetics and Toxicology2026
8. Centrally Acting Agents: ADMET Fundamentals, Blood-Brain Barrier Penetration, and Their Role in Clinical Pharmacokinetics and Toxicology2026
9. Clinical Study Report (CSR) Design for Long-Acting Injectable Antipsychotic Pivotal Trials2026
10. Highly Protein-Bound, Narrow Therapeutic Index Drugs: ADMET Fundamentals and Their Role in Clinical Pharmacokinetics and Toxicology2026
11. Perspectives and Insights on Biomarker-Driven Breast Cancer Therapeutics: From Preclinical Development to Submission of an Investigational New Drug (IND) Application to the FDA2026
12. Oral Small-Molecule Kinase Inhibitors: ADMET Fundamentals, Cytochrome P450-Mediated Drug-Drug Interactions, and Their Role in Clinical Pharmacokinetics and Toxicology2026
13. Prodrugs: ADMET Fundamentals, Bioactivation Kinetics, and Their Role in Clinical Pharmacokinetics and Toxicology2026
14. Resource Planning for a GLP Toxicology Program Supporting FDA IND Submission: A Budget Proposal for a Targeted RAS Pathway Inhibitor2026
15. Standard Operating Procedures for eCTD Lifecycle Management in Autologous CAR T Cell Therapy Programs: Chain of Identity as the Organizing Principle2026
16. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for Targeted RAS Pathway Inhibitors in Advanced Solid Tumors2026
17. Monoclonal Antibody Therapeutics: ADMET Fundamentals, Target-Mediated Drug Disposition, and Their Role in Clinical Pharmacokinetics and Toxicology2026
18. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for Oral GLP-1 Receptor Agonists in Type 2 Diabetes and Obesity2026
19. Writing and Amending the Clinical Protocol: IND and CTA Lifecycle Strategy for Novel Anxiolytic Agents in Generalized Anxiety Disorder2026
20. KRAS G12C Inhibitors: Analytical Quality Control, HPLC Assay and Related-Substance Profiling, and CMC Regulatory Expectations2026