88
Citations
45
Journals
2019
First Cited
2022
Last Cited

Articles citing This Document (Page 1 of 2)

ArticleJournalYear
Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology
Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children2022
Bioavailability of Oniria®, a Melatonin Prolonged-Release Formulation, Versus Immediate-Release Melatonin in Healthy Volunteers
Bioequivalence, Drugs with Narrow Therapeutic Index and the Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution2022
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)2022
Pharmacokinetics and Metabolomic Profiling of Metformin and Andrographis paniculata: A Protocol for a Crossover Randomised Controlled TrialJournal of Clinical Medicine2022
Bioequivalence Studies: Reference and Test Products2022
Bioequivalence Studies2022
Drug Dissolution Profile Comparison2022
Bioequivalence Studies: Pre- and Post-Approval Changes2022
Bioequivalence Studies: Generic Products2022
Biopharmaceutics Drug Disposition Classification System2022
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).Bioanalysis2022
Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites.Clinical Therapeutics2022
Directly compressible formulation of immediate release rosuvastatin calcium tablets stabilized with tribasic calcium phosphate.Pharmaceutical Development and Technology2022
Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers.Diabetes Therapy2022
Development of a Hospital Compounded, Taste-Masked, Temozolomide Oral Suspension and 5-Year Real-Life Experience in Treating Paediatric PatientsPharmaceuticals2022
Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial.Expert Review of Clinical Immunology2022
Prescription and use of some generic drugs in ophthalmology: possible legal and medico-legal implications2022
Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development.AAPS PharmSciTech2022
Flux-Based Formulation Development-A Proof of Concept Study.AAPS Journal2022
An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and IndiaExpert Opinion on Drug Delivery2021
Comparison of clinical effects, trough and peak levels between branded and generic formulation of Cyclosporine in stable psoriatic patientsGiornale Italiano Di Dermatologia E Venereologia2020
Institutional Corruption of Medical Knowledge ProductionStudies of Organized Crime2020
Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence DecisionFrontiers in Medicine2020
Real world clinical experience with a new formulation of levothyroxine engineered to meet new and stricter regulatory requirementsCurrent Medical Research and Opinion2021
Comparative Bioavailability of Two Formulations of Biopharmaceutical Classification System (BCS) Class IV Drugs: A Case Study of Lopinavir/RitonavirJournal of Pharmaceutical Sciences2021
A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteersExpert Opinion on Biological Therapy2021
Bioequivalence of Oral Drug Products in the Healthy and Special Populations: Assessment and Prediction Using a Newly Developed In Vitro System "BE Checker"Pharmaceutics2021
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized RelianceBioDrugs2021
In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual PopulationClinical Pharmacokinetics2021
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence StudiesTherapeutic Innovation and Regulatory Science2021
Prediction of pharmacokinetic studies outcome for locally acting nasal sprays by using different in vitro methodsInternational Journal of Pharmaceutics2021
TAS-116, a Well-Tolerated Hsp90 Inhibitor, Prevents the Activation of the NLRP3 Inflammasome in Human Retinal Pigment Epithelial CellsInternational Journal of Molecular Sciences2021
Statistical inference in abstracts of three influential clinical pharmacology journals analyzed using a text-mining algorithmBritish Journal of Clinical Pharmacology2021
Sustainable preparation of anti-inflammatory atorvastatin PLGA nanoparticlesInternational Journal of Pharmaceutics2021
High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy SubjectsFrontiers in Pharmacology2021
Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label StudiesEuropean Journal of Drug Metabolism and Pharmacokinetics2021
Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines AgencyFrontiers in Medicine2021
Feasibility of Extrapolating Randomly Taken Plasma Samples to Trough Levels for Therapeutic Drug Monitoring Purposes of Small Molecule Kinase InhibitorsPharmaceuticals2021
The ADME Encyclopedia2021
The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy VolunteersClinical Pharmacology in Drug Development2021
In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulationEuropean Journal of Pharmaceutical Sciences2021
Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjectsEuropean Journal of Clinical Pharmacology2021
Does dose reduction of renally cleared antibiotics in patients with impaired renal function lead to adequate drug exposure? A systematic reviewClinical Microbiology and Infection2021
A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjectsCancer Chemotherapy and Pharmacology2021
Influence of Cow's Milk and Esomeprazole on the Absorption of Erlotinib: A Randomized, Crossover Pharmacokinetic Study in Lung Cancer PatientsClinical Pharmacokinetics2021
Enhancement of abiraterone acetate oral bioavailability by supersaturated-silica lipid hybridsInternational Journal of Pharmaceutics2020
Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic reviewInternational Journal of Clinical Pharmacy2020
Oral formulation strategies to improve the bioavailability and mitigate the food effect of abiraterone acetateInternational Journal of Pharmaceutics2020