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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.
- Published in:
- 2019
- By:
- Publication type:
- journal article
Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union.
- Published in:
- Pharmaceutics, 2023, v. 15, n. 2, p. 601, doi. 10.3390/pharmaceutics15020601
- By:
- Publication type:
- Article
Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State—A Case Study.
- Published in:
- Pharmaceutics, 2023, v. 15, n. 2, p. 409, doi. 10.3390/pharmaceutics15020409
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- Publication type:
- Article
Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients.
- Published in:
- Pharmaceutics, 2022, v. 14, n. 12, p. 2565, doi. 10.3390/pharmaceutics14122565
- By:
- Publication type:
- Article
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
- Published in:
- Pharmaceutics, 2022, v. 14, n. 11, p. 2349, doi. 10.3390/pharmaceutics14112349
- By:
- Publication type:
- Article
Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making.
- Published in:
- Pharmaceutics, 2021, v. 13, n. 5, p. 709, doi. 10.3390/pharmaceutics13050709
- By:
- Publication type:
- Article
One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products.
- Published in:
- Pharmaceutics, 2021, v. 13, n. 5, p. 690, doi. 10.3390/pharmaceutics13050690
- By:
- Publication type:
- Article
An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products.
- Published in:
- Pharmaceutics, 2021, v. 13, n. 4, p. 507, doi. 10.3390/pharmaceutics13040507
- By:
- Publication type:
- Article
Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms.
- Published in:
- Pharmaceutics, 2020, v. 12, n. 12, p. 1159, doi. 10.3390/pharmaceutics12121159
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- Publication type:
- Article
Candesartan Cilexetil In Vitro–In Vivo Correlation: Predictive Dissolution as a Development Tool.
- Published in:
- Pharmaceutics, 2020, v. 12, n. 7, p. 633, doi. 10.3390/pharmaceutics12070633
- By:
- Publication type:
- Article
Erratum: Mangas-Sanjuán, V.; et al. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence. Pharmaceutics 2019, 11, 503.
- Published in:
- 2020
- By:
- Publication type:
- Correction Notice
Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products.
- Published in:
- Pharmaceutics, 2019, v. 11, n. 12, p. 663, doi. 10.3390/pharmaceutics11120663
- By:
- Publication type:
- Article
Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence.
- Published in:
- Pharmaceutics, 2019, v. 11, n. 10, p. 503, doi. 10.3390/pharmaceutics11100503
- By:
- Publication type:
- Article
Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses.
- Published in:
- Pharmaceutics, 2019, v. 11, n. 3, p. 122, doi. 10.3390/pharmaceutics11030122
- By:
- Publication type:
- Article
A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets.
- Published in:
- Patient Preference & Adherence, 2018, v. 12, p. 1927, doi. 10.2147/PPA.S174479
- By:
- Publication type:
- Article
In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.
- Published in:
- Biopharmaceutics & Drug Disposition, 2012, v. 33, n. 7, p. 366, doi. 10.1002/bdd.1800
- By:
- Publication type:
- Article
High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects.
- Published in:
- Frontiers in Pharmacology, 2021, v. 11, p. N.PAG, doi. 10.3389/fphar.2021.664465
- By:
- Publication type:
- Article
Global Harmonization of Comparator Products for Bioequivalence Studies.
- Published in:
- AAPS Journal, 2017, v. 19, n. 3, p. 603, doi. 10.1208/s12248-017-0068-6
- By:
- Publication type:
- Article
Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles.
- Published in:
- AAPS Journal, 2016, v. 18, n. 6, p. 1550, doi. 10.1208/s12248-016-9971-5
- By:
- Publication type:
- Article
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.
- Published in:
- 2015
- By:
- Publication type:
- Report
Bioequivalence Requirements in the European Union: Critical Discussion.
- Published in:
- AAPS Journal, 2012, v. 14, n. 4, p. 738, doi. 10.1208/s12248-012-9382-1
- By:
- Publication type:
- Article
Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence.
- Published in:
- 2012
- By:
- Publication type:
- Report
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.
- Published in:
- Chirality, 2020, v. 32, n. 9, p. 1169, doi. 10.1002/chir.23258
- By:
- Publication type:
- Article
Effect of enantiomerism on the bioequivalence of a new ibuprofen 600‐mg tablet formulation obtained by roller compaction.
- Published in:
- Chirality, 2020, v. 32, n. 2, p. 185, doi. 10.1002/chir.23148
- By:
- Publication type:
- Article
Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base.
- Published in:
- Chirality, 2016, v. 28, n. 5, p. 429, doi. 10.1002/chir.22598
- By:
- Publication type:
- Article
Reasons to use stereoselective assay methods.
- Published in:
- Chirality, 2012, v. 24, n. 7, p. 499, doi. 10.1002/chir.22022
- By:
- Publication type:
- Article
Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.
- Published in:
- British Journal of Clinical Pharmacology, 2019, v. 85, n. 9, p. 2059, doi. 10.1111/bcp.13997
- By:
- Publication type:
- Article
Response to 'Sex‐by‐formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions' by Ibarra et al.
- Published in:
- 2019
- By:
- Publication type:
- Letter to the Editor
Evaluation of sex‐by‐formulation interaction in bioequivalence studies of efavirenz tablets.
- Published in:
- British Journal of Clinical Pharmacology, 2018, v. 84, n. 8, p. 1729, doi. 10.1111/bcp.13601
- By:
- Publication type:
- Article
Sensitive studies with a significant dose-response curve for inhaled corticosteroids to investigate equivalent relative potency are feasible.
- Published in:
- British Journal of Clinical Pharmacology, 2011, v. 72, n. 5, p. 832, doi. 10.1111/j.1365-2125.2011.04017.x
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- Publication type:
- Article
The failure to show bioequivalence is not evidence against generics.
- Published in:
- 2010
- By:
- Publication type:
- Letter
Sex-by-formulation interaction in bioequivalence trials with transdermal patches.
- Published in:
- European Journal of Clinical Pharmacology, 2019, v. 75, n. 6, p. 801, doi. 10.1007/s00228-019-02632-1
- By:
- Publication type:
- Article
Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons.
- Published in:
- Annals of Neurology, 2012, v. 71, n. 5, p. 724, doi. 10.1002/ana.23583
- By:
- Publication type:
- Article
A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 2, p. 470, doi. 10.1002/cpt.2451
- By:
- Publication type:
- Article
Investigation on the Existence of Sex‐By‐Formulation Interaction in Bioequivalence Trials.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 5, p. 1099, doi. 10.1002/cpt.1539
- By:
- Publication type:
- Article
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
- Published in:
- Journal of Pharmacy & Pharmaceutical Sciences, 2021, v. 24, p. 548, doi. 10.18433/jpps32260
- By:
- Publication type:
- Article
A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme.
- Published in:
- Journal of Pharmacy & Pharmaceutical Sciences, 2018, v. 21, p. 27, doi. 10.18433/j3x93k
- By:
- Publication type:
- Article
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons.
- Published in:
- European Journal of Clinical Pharmacology, 2015, v. 71, n. 9, p. 1083, doi. 10.1007/s00228-015-1889-9
- By:
- Publication type:
- Article
Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison.
- Published in:
- European Journal of Clinical Pharmacology, 2013, v. 69, n. 5, p. 1157, doi. 10.1007/s00228-012-1456-6
- By:
- Publication type:
- Article
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
- Published in:
- European Journal of Clinical Pharmacology, 2012, v. 68, n. 12, p. 1611, doi. 10.1007/s00228-012-1396-1
- By:
- Publication type:
- Article
Differences in lercanidipine systemic exposure when administered according to labelling: in fasting state and 15 minutes before food intake.
- Published in:
- European Journal of Clinical Pharmacology, 2012, v. 68, n. 7, p. 1043, doi. 10.1007/s00228-012-1215-8
- By:
- Publication type:
- Article
Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies.
- Published in:
- European Journal of Clinical Pharmacology, 2010, v. 66, n. 6, p. 599, doi. 10.1007/s00228-010-0792-7
- By:
- Publication type:
- Article
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 556, doi. 10.1002/psp4.12906
- By:
- Publication type:
- Article
A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union.
- Published in:
- Pharmaceutics, 2024, v. 16, n. 5, p. 598, doi. 10.3390/pharmaceutics16050598
- By:
- Publication type:
- Article
Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications.
- Published in:
- CTS: Clinical & Translational Science, 2019, v. 12, n. 5, p. 490, doi. 10.1111/cts.12642
- By:
- Publication type:
- Article
An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies.
- Published in:
- Chirality, 2005, v. 17, n. 8, p. 470, doi. 10.1002/chir.20186
- By:
- Publication type:
- Article