Works matching IS 15507416 AND DT 2020 AND VI 22 AND IP 5
Results: 28
A Three-Treatment Two-Stage Design for Selection of a Candidate Formulation and Subsequent Demonstration of Bioequivalence.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00492-7
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- Article
Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance.
- Published in:
- 2020
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- Publication type:
- Correction Notice
Investigating the Theoretical Basis for In Vitro–In Vivo Extrapolation (IVIVE) in Predicting Drug Metabolic Clearance and Proposing Future Experimental Pathways.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00501-9
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- Article
Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the Between-Batch Variability.
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- AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00486-5
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- Article
A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation.
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- AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00503-7
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- Article
HIV-1 Sanctuary Sites—the Role of Membrane-Associated Drug Transporters and Drug Metabolic Enzymes.
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- AAPS Journal, 2020, v. 22, n. 5, p. 1, doi. 10.1208/s12248-020-00498-1
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- Article
Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00500-w
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- Article
Inter-compound and Intra-compound Global Sensitivity Analysis of a Physiological Model for Pulmonary Absorption of Inhaled Compounds.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00499-0
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- Article
Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00497-2
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- Article
Pitfalls in Predicting Hepatobiliary Drug Transport Using Human Sandwich-Cultured Hepatocytes.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00496-3
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- Article
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00495-4
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- Article
Challenge-Enabled Machine Learning to Drug-Response Prediction.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00494-5
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- Publication type:
- Article
Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00493-6
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- Publication type:
- Article
Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00491-8
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- Publication type:
- Article
The Effects of Dose Volume and Excipient Dose on Luminal Concentration and Oral Drug Absorption.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00490-9
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- Article
PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00489-2
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- Publication type:
- Article
Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00488-3
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- Publication type:
- Article
Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®.
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- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00487-4
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- Publication type:
- Article
Association Between Vomiting and QT Hysteresis: Data from a TQT Study with the Endothelin A Receptor Antagonist Clazosentan.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00485-6
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- Publication type:
- Article
Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00484-7
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- Publication type:
- Article
Correction to: Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Additional Benefit.
- Published in:
- 2020
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- Publication type:
- Correction Notice
Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00480-x
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- Publication type:
- Article
Application of Beta-Distribution and Combined Uniform and Binomial Methods in Longitudinal Modeling of Bounded Outcome Score Data.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00478-5
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- Article
Capturing the Magic Bullet: Pharmacokinetic Principles and Modeling of Antibody-Drug Conjugates.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00475-8
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- Publication type:
- Article
A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00477-6
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- Publication type:
- Article
Discovery of a Highly Selective Sigma-2 Receptor Ligand, 1-(4-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)butyl)-3-methyl-1H-benzo[d]imidazol-2(3H)-one (CM398), with Drug-Like Properties and Antinociceptive Effects In Vivo.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00472-x
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- Publication type:
- Article
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00470-z
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- Publication type:
- Article
The Necessity of Using Changes in Absorption Time to Implicate Intestinal Transporter Involvement in Oral Drug-Drug Interactions.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00469-6
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- Publication type:
- Article