Works matching IS 15507416 AND DT 2022 AND VI 24 AND IP 3
Results: 25
When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00712-2
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- Publication type:
- Article
A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00716-y
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- Publication type:
- Article
Biomarker Assay Validation by Mass Spectrometry.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00707-z
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- Publication type:
- Article
Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00708-y
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- Publication type:
- Article
Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System.
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- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00715-z
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- Publication type:
- Article
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00714-0
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- Publication type:
- Article
A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00713-1
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- Publication type:
- Article
A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00711-3
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- Publication type:
- Article
Tumor Growth Inhibition-Overall Survival (TGI-OS) Model for Subgroup Analysis Based on Post-Randomization Factors: Application for Anti-drug Antibody (ADA) Subgroup Analysis of Atezolizumab in the IMpower150 Study.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00710-4
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- Publication type:
- Article
A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00709-x
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- Publication type:
- Article
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories.
- Published in:
- 2022
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- Publication type:
- Correction Notice
Machine Learning Prediction of Clinical Trial Operational Efficiency.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00703-3
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- Publication type:
- Article
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00702-4
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- Publication type:
- Article
Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00701-5
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- Publication type:
- Article
The AAPS Journal Theme Issue: Rising Stars in Drug Delivery and Novel Carriers.
- Published in:
- 2022
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- Publication type:
- Editorial
Population Pharmacodynamic Modeling of Eflornithine-Based Treatments Against Late-Stage Gambiense Human African Trypanosomiasis and Efficacy Predictions of L-eflornithine-Based Therapy.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00693-2
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- Publication type:
- Article
Targeted Delivery of Endosomal Escape Peptides to Enhance Immunotoxin Potency and Anti-cancer Efficacy.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00698-x
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- Publication type:
- Article
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00697-y
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- Publication type:
- Article
Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00696-z
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- Publication type:
- Article
Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties.
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- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00695-0
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- Publication type:
- Article
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00699-w
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- Publication type:
- Article
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00691-4
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- Publication type:
- Article
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00683-4
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- Publication type:
- Article
A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00682-5
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- Publication type:
- Article
In Vitro Assessment of Transporter Mediated Perpetrator DDIs for Several Hepatitis C Virus Direct-Acting Antiviral Drugs and Prediction of DDIs with Statins Using Static Models.
- Published in:
- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-021-00677-8
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- Publication type:
- Article