| 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 |
| The biorelevant simulation of gastric emptying and its impact on model drug dissolution and absorption kinetics | European Journal of Pharmaceutics and Biopharmaceutics | 2020 |
| Marketing authorization and licensing of medicinal products in EU: Regulatory aspects | | 2020 |
| Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen | Chirality | 2020 |
| Pharmacokinetics and Generic Drug Switching: A Regulator's View | Clinical Pharmacokinetics | 2020 |
| Physiologically Based Dissolution Testing in a Drug Development Process-a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions | AAPS PharmSciTech | 2020 |
| Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b) | Pharmaceutics | 2020 |
| Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets | European Journal of Pharmaceutical Sciences | 2020 |
| Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan Retard) Compared with Other Formulations in Healthy Volunteers | Pulmonary Therapy | 2020 |
| Application of Dominance-Based Rough Set Approach for Optimization of Pellets Tableting Process | Pharmaceutics | 2020 |
| Levonorgestrel release rates measured through analysis of two-rod contraceptive explants | Contraception: X | 2020 |
| Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms | Pharmaceutics | 2020 |
| Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products | AAPS Journal | 2020 |
| Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus | Drug, Healthcare and Patient Safety | 2020 |
| Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation | BMC Research Notes | 2020 |
| Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients | Respiratory Research | 2020 |
| 10th Anniversary of a Two-Stage Design in Bioequivalence. Why Has it Still Not Been Implemented? | Pharmaceutical Research | 2020 |
| An enteric polymer mitigates the effects of gastric pH on oral absorption of poorly soluble weak acid drugs from supersaturable formulations: A case study with dantrolene | European Journal of Pharmaceutics and Biopharmaceutics | 2020 |
| Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection | Clinical Pharmacokinetics | 2020 |
| Pharmacokinetics and Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: An Open, Randomized, Single-Dose, Double-Cycle, Two-Sequence, Crossover Trial | Frontiers in Pharmacology | 2020 |
| Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market | BMC Research Notes | 2020 |
| Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM) | European Journal of Pharmaceutical Sciences | 2020 |
| BCS-based biowaivers: Extension to paediatrics | European Journal of Pharmaceutical Sciences | 2020 |
| Use of calcium carbonate as an excipient for release of poorly water soluble drugs: The case of carbamazepine | International Journal of Pharmaceutics | 2020 |
| Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?" | Clinical Pharmacokinetics | 2020 |
| Effects of oral iron and calcium supplement on the pharmacokinetics and pharmacodynamics of molidustat: an oral HIF-PH inhibitor for the treatment of renal anaemia | European Journal of Clinical Pharmacology | 2020 |
| Bioequivalence of a Newly Developed Dabigatran Etexilate Tablet Versus the Commercial Capsule and Impact of Rabeprazole-Induced Elevated Gastric pH on Exposure in Healthy Subjects | American Journal of Cardiovascular Drugs | 2020 |
| Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults | Clinical Pharmacology in Drug Development | 2020 |
| Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One? | Clinical Pharmacokinetics | 2020 |
| Representative sample survey on factors determining the Czech physicians' awareness of generic drugs and substitution | BMC Health Services Research | 2019 |
| In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation | Pharmaceutics | 2019 |
| Cutaneous Biodistribution: A High-Resolution Methodology to Assess Bioequivalence in Topical Skin Delivery | Pharmaceutics | 2019 |
| Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution | Advances in Therapy | 2019 |
| Pharmacokinetics of Total and Unbound Paclitaxel After Administration of Paclitaxel Micellar or Nab-Paclitaxel: An Open, Randomized, Cross-Over, Explorative Study in Breast Cancer Patients | Advances in Therapy | 2019 |
| Analytical Solution and Exposure Analysis of a Pharmacokinetic Model with Simultaneous Elimination Pathways and Endogenous Production: The Case of Multiple Dosing Administration | Bulletin of Mathematical Biology | 2019 |
| Development of In Vitro-In Vivo Correlation for Upadacitinib Extended-Release Tablet Formulation | AAPS Journal | 2019 |
| Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System | Pharmaceutics | 2019 |
| Effect of casting solvent, film-forming agent and solubilizer on orodispersible films of a polymorphic poorly soluble drug: an / study | Drug Development and Industrial Pharmacy | 2019 |
| Clinical efficacy of sublingual immunotherapy tablets for allergic rhinitis is unlikely to be derived from allergen-release data | Expert Review of Clinical Immunology | 2019 |
