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 Children | | 2022 |
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 Substitution | | 2022 |
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 Trial | Journal of Clinical Medicine | 2022 |
Bioequivalence Studies: Reference and Test Products | | 2022 |
Bioequivalence Studies | | 2022 |
Drug Dissolution Profile Comparison | | 2022 |
Bioequivalence Studies: Pre- and Post-Approval Changes | | 2022 |
Bioequivalence Studies: Generic Products | | 2022 |
Biopharmaceutics Drug Disposition Classification System | | 2022 |
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). | Bioanalysis | 2022 |
Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites. | Clinical Therapeutics | 2022 |
Directly compressible formulation of immediate release rosuvastatin calcium tablets stabilized with tribasic calcium phosphate. | Pharmaceutical Development and Technology | 2022 |
Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers. | Diabetes Therapy | 2022 |
Development of a Hospital Compounded, Taste-Masked, Temozolomide Oral Suspension and 5-Year Real-Life Experience in Treating Paediatric Patients | Pharmaceuticals | 2022 |
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 Immunology | 2022 |
Prescription and use of some generic drugs in ophthalmology: possible legal and medico-legal implications | | 2022 |
Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development. | AAPS PharmSciTech | 2022 |
Flux-Based Formulation Development-A Proof of Concept Study. | AAPS Journal | 2022 |
An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and India | Expert Opinion on Drug Delivery | 2021 |
Comparison of clinical effects, trough and peak levels between branded and generic formulation of Cyclosporine in stable psoriatic patients | Giornale Italiano Di Dermatologia E Venereologia | 2020 |
Institutional Corruption of Medical Knowledge Production | Studies of Organized Crime | 2020 |
Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision | Frontiers in Medicine | 2020 |
Real world clinical experience with a new formulation of levothyroxine engineered to meet new and stricter regulatory requirements | Current Medical Research and Opinion | 2021 |
Comparative Bioavailability of Two Formulations of Biopharmaceutical Classification System (BCS) Class IV Drugs: A Case Study of Lopinavir/Ritonavir | Journal of Pharmaceutical Sciences | 2021 |
A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers | Expert Opinion on Biological Therapy | 2021 |
Bioequivalence of Oral Drug Products in the Healthy and Special Populations: Assessment and Prediction Using a Newly Developed In Vitro System "BE Checker" | Pharmaceutics | 2021 |
Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance | BioDrugs | 2021 |
In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population | Clinical Pharmacokinetics | 2021 |
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies | Therapeutic Innovation and Regulatory Science | 2021 |
Prediction of pharmacokinetic studies outcome for locally acting nasal sprays by using different in vitro methods | International Journal of Pharmaceutics | 2021 |
TAS-116, a Well-Tolerated Hsp90 Inhibitor, Prevents the Activation of the NLRP3 Inflammasome in Human Retinal Pigment Epithelial Cells | International Journal of Molecular Sciences | 2021 |
Statistical inference in abstracts of three influential clinical pharmacology journals analyzed using a text-mining algorithm | British Journal of Clinical Pharmacology | 2021 |
Sustainable preparation of anti-inflammatory atorvastatin PLGA nanoparticles | International Journal of Pharmaceutics | 2021 |
High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects | Frontiers in Pharmacology | 2021 |
Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies | European Journal of Drug Metabolism and Pharmacokinetics | 2021 |
Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency | Frontiers in Medicine | 2021 |
Feasibility of Extrapolating Randomly Taken Plasma Samples to Trough Levels for Therapeutic Drug Monitoring Purposes of Small Molecule Kinase Inhibitors | Pharmaceuticals | 2021 |
The ADME Encyclopedia | | 2021 |
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 Volunteers | Clinical Pharmacology in Drug Development | 2021 |
In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulation | European Journal of Pharmaceutical Sciences | 2021 |
Safety, pharmacodynamic, and pharmacokinetic characterization of vericiguat: results from six phase I studies in healthy subjects | European Journal of Clinical Pharmacology | 2021 |
Does dose reduction of renally cleared antibiotics in patients with impaired renal function lead to adequate drug exposure? A systematic review | Clinical Microbiology and Infection | 2021 |
A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects | Cancer Chemotherapy and Pharmacology | 2021 |
Influence of Cow's Milk and Esomeprazole on the Absorption of Erlotinib: A Randomized, Crossover Pharmacokinetic Study in Lung Cancer Patients | Clinical Pharmacokinetics | 2021 |
Enhancement of abiraterone acetate oral bioavailability by supersaturated-silica lipid hybrids | International Journal of Pharmaceutics | 2020 |
Effects of generic exchange of solid oral dosage forms in neurological disorders: a systematic review | International Journal of Clinical Pharmacy | 2020 |
Oral formulation strategies to improve the bioavailability and mitigate the food effect of abiraterone acetate | International Journal of Pharmaceutics | 2020 |