191 results on '"Lyapustina, Svetlana"'
Search Results
2. Evaluation of the Sensitivity and Robustness of Modified Chi-Square Ratio Statistic for Cascade Impactor Equivalence Testing Through Monte Carlo Simulations
3. Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release
4. Product Life Cycle Approach to Cascade Impaction Measurements
5. Conclusions
6. Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers
7. Performance of the Population Bioequivalence (PBE) Statistical Test with Impactor Sized Mass Data
8. Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA’s Average Bioequivalence Approach
9. Determination of Passive Dry Powder Inhaler Aerodynamic Particle Size Distribution by Multi-Stage Cascade Impactor: International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Recommendations to Support Both Product Quality Control and Clinical Programs
10. Discriminating Ability of Abbreviated Impactor Measurement Approach (AIM) to Detect Changes in Mass Median Aerodynamic Diameter (MMAD) of an Albuterol/Salbutamol pMDI Aerosol
11. A Comparison of the Performance of Efficient Data Analysis Versus Fine Particle Dose as Metrics for the Quality Control of Aerodynamic Particle Size Distributions of Orally Inhaled Pharmaceuticals
12. Moving Forward from “Fine Particle Fraction: The Good and the Bad”
13. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference
14. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
15. Challenges with Developing In Vitro Dissolution Tests for Orally Inhaled Products (OIPs)
16. On the Shelf Life of Pharmaceutical Products
17. Challenges and Opportunities in Implementing the FDA Default Parametric Tolerance Interval Two One-Sided Test for Delivered Dose Uniformity of Orally Inhaled Products
18. Non-impactor-Based Methods for Sizing of Aerosols Emitted from Orally Inhaled and Nasal Drug Products (OINDPs)
19. Product Lifecycle Approach to Cascade Impaction Measurements
20. Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 2—Investigation of Bias in Extra-Fine Mass Fraction with AIM-HRT Impactor
21. Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 1
22. Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)
23. A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test
24. A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 3—Investigation of Robustness to Deviations from Normality
25. A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 2—Effect of Changing Parameters
26. Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers
27. Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence
28. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 2—Evaluation of a method for determining equivalence
29. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method
30. Urgent Appeal from International Society for Aerosols in Medicine (ISAM) During COVID-19: Clinical Decision Makers and Governmental Agencies Should Consider the Inhaled Route of Administration: A Statement from the ISAM Regulatory and Standardization Issues Networking Group
31. Reflections on Digital Health Tools for Respiratory Applications
32. Excess electrons bound to H2S trimer and tetramer clusters
33. Quality by design for analytical methods for use with orally inhaled and nasal drug products; a discussion of what to consider when embarking on the development of analytical methods for use with orally inhaled and nasal drugs products, and where these points might fit in to a Quality by Design development programme
34. Excess electrons bound to H2S trimer and tetramer clusters.
35. Highlights from the 2017 IPAC-RS/ISAM Joint Workshop “New Frontiers in Inhalation Technology”
36. Regulatory pitfalls and opportunities when repurposing for inhalation therapy
37. Photoelectron spectroscopy of hydrated adenine anions.
38. Anion solvation at the microscopic level: Photoelectron spectroscopy of the solvated anion clusters, NO[sup -](Y)[sub n], where Y=Ar, Kr, Xe, N[sub 2]O, H[sub 2]S, NH[sub 3], H[sub 2]O, and C[sub 2]H[sub 4](OH)[sub 2].
39. Photoelectron spectroscopy of naphthalene cluster anions.
40. Product Quality Research Institute reports
41. Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop
42. Negative ion photoelectron spectroscopy of the ground state, dipole-bound dimeric anion, (HF)...
43. A Comparison of the Performance of Efficient Data Analysis Versus Fine Particle Dose as Metrics for the Quality Control of Aerodynamic Particle Size Distributions of Orally Inhaled Pharmaceuticals
44. The onset of electron-induced proton-transfer in hydrated azabenzene cluster anions
45. Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report
46. Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report
47. Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report
48. Photoelectron spectroscopy of homogeneous nucleic acid base dimer anions
49. Comparison of Two Approaches for Treating Cascade Impaction Mass Balance Measurements
50. Aspects of Particle Science and Regulation in Pharmaceutical Inhalation Drug Products
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.