15 results on '"Lionberger, Robert"'
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2. Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop
3. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report
4. Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users
5. Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective
6. Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?
7. Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology
8. Current Scientific Considerations to Verify Physiologically‐Based Pharmacokinetic Models and Their Implications for Locally Acting Products
9. Decision Science for Generic Drug Development and Review
10. Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012
11. Generic Drugs: Expanding Possibilities for Clinical Pharmacology
12. Generating Model Integrated Evidence for Generic Drug Development and Assessment
13. Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop
14. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard
15. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
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