38 results on '"Garcia Arieta, Alfredo"'
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2. Bioequivalence risk assessment of oral formulations containing racemic ibuprofen through a chiral physiologically based pharmacokinetic model of ibuprofen enantiomers
3. A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms
4. Estimators and confidence intervals of [formula omitted] using bootstrap methodology for the comparison of dissolution profiles
5. A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union.
6. Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid
7. Validation of a semi-physiological model for caffeine in healthy subjects and cirrhotic patients
8. A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
9. Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles
10. Investigation on the Possibility of Biowaivers for Ibuprofen
11. A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
12. Computer simulations for bioequivalence trials: Selection of analyte in BCS drugs with first-pass metabolism and two metabolic pathways
13. On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs
14. An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products
15. A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme
16. In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen
17. A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
18. Effect of enantiomerism on the bioequivalence of a new ibuprofen 600‐mg tablet formulation obtained by roller compaction
19. The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
20. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence
21. Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
22. Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses
23. A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme
24. How to compare two different metered-dose inhaler-valved holding chambers in the administration of salbutamol
25. Effect of enantiomerism on the bioequivalence of a new ibuprofen 600‐mg tablet formulation obtained by roller compaction.
26. On the Biopharmaceutics Classification System Biowaiver of Ibuprofen
27. Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: Impact on bioequivalence
28. A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets.
29. Agitation Rate and Time for Complete Dissolution in BCS Biowaivers Based on Investigation of a BCS Biowaiver for Dexketoprofen Tablets
30. About the equivalence between different batches of a glycopeptide drug
31. WITHDRAWN: Efficacy and safety of Flutiform compared with individual fluticasone and formoterol reference products
32. Composition specification of teicoplanin based on its estimated relative bioavailability
33. About the equivalence between different batches of a glycopeptide drug.
34. Reasons to use stereoselective assay methods
35. Regulatory Considerations for Generic or Biosimilar Low Molecular Weight Heparins
36. On the BCS biowaivers of orally disintegrating tablets
37. Composition specification of teicoplanin based on its estimated relative bioavailability.
38. PII: S0149-2918(09)00482-2
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