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Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs
Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs
Intravitreally administered biotherapeutics can elicit local and systemic immune responses with potentially serious clinic...
Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners
Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners
Prior to his passing, Dr. Roger Jelliffe, expressed the need for educating future physicians and clinical pharmacists on t...
A Non-radiometric Approach to Determine Tissue Vascular Blood Volume in Biodistribution Studies
A Non-radiometric Approach to Determine Tissue Vascular Blood Volume in Biodistribution Studies
The aim of this research was to develop a reliable non-radiometric method to measure the residual blood in tissue without ...
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model
Overexposure to ultraviolet radiation and environmental carcinogens drive skin cancer development through redox imbalance ...
Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation
Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation
Characterization of clinical anti-drug antibody (ADA) responses to biotherapeutics can be important to understanding the c...
Anti-drug Antibody Sample Testing and Reporting Harmonization
Anti-drug Antibody Sample Testing and Reporting Harmonization
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate c...
A Novel Bootstrapping Test for Analytical Biosimilarity
A Novel Bootstrapping Test for Analytical Biosimilarity
Showing analytical similarity is key to license biosimilar products with reduced or circumvented clinical effort. Statisti...
Identification of Potential Megalin/Cubilin Substrates Using Extensive Proteomics Quantification from Kidney Megalin-Knockdown Mice
Identification of Potential Megalin/Cubilin Substrates Using Extensive Proteomics Quantification from Kidney Megalin-Knockdown Mice
Megalin and cubilin, endocytic proteins present in the proximal tubule of the kidney, are responsible for reabsorbing filt...
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience
Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience
Over the past several decades, pharmaceutical manufacturing has become increasingly global and supply chains have become l...
FOLFIRINOX Pharmacodynamic Interactions in 2D and 3D Pancreatic Cancer Cell Cultures
FOLFIRINOX Pharmacodynamic Interactions in 2D and 3D Pancreatic Cancer Cell Cultures
The multi-drug combination regime, FOLFIRINOX, is a standard of care chemotherapeutic therapy for pancreatic cancer patien...
Phish-Pharm: A Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish — 2022 Update
Phish-Pharm: A Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish — 2022 Update
A new version of Phish-Pharm: a Searchable Database of Pharmacokinetics and Drug Residue Literature in Fish has been updat...
Does an Intradermal Vaccination for Monkeypox Make Sense?
Does an Intradermal Vaccination for Monkeypox Make Sense?
Mankind has recently had to deal a series of virus-mediated pandemics, resulting in extensive morbidity and mortality rate...
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody
The development of new antibody–drug conjugates (ADCs) has led to the approval of 7 ADCs by the FDA in 4 ye...
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines
This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) d...
Usage of Compartmental Models in Predicting COVID-19 Outbreaks
Usage of Compartmental Models in Predicting COVID-19 Outbreaks
Accurately predicting the spread of the SARS-CoV-2, the cause of the COVID-19 pandemic, is of great value for global regul...
Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies
Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies
The two one-sided t-tests (TOST) procedure has been used to evaluate average bioequivalence (BE). As a regulatory standard...
Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)
Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)
Oligonucleotide therapeutics (ONTs) are a diverse group of short synthetic nucleic acid–based molecules that exploit...
Scientific Considerations for Stability Studies of Drug Substances Supporting Abbreviated New Drug Applications (ANDAs)
Scientific Considerations for Stability Studies of Drug Substances Supporting Abbreviated New Drug Applications (ANDAs)
We have summarized five high impact issues related to the stability studies for drug substances that are documented in the...
Determinants of Biological Half-Lives and Terminal Slopes in Physiologically Based Pharmacokinetic Systems: Assessment of Limiting Conditions
Determinants of Biological Half-Lives and Terminal Slopes in Physiologically Based Pharmacokinetic Systems: Assessment of Limiting Conditions
In pharmacokinetic (PK) analyses, the biological half-life T1/2 is usually determined in the terminal phase after drug adm...