| Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation | | 2022 |
| Study protocol: computerised cognitive testing in a cohort of people with frontotemporal dementia | | 2022 |
| A new Febuxostat-Telmisartan drug-drug cocrystal for gout-hypertension combination therapy | | 2022 |
| Patient Perspective on Acute Hepatic Porphyria with Sporadic Attacks: A Chronic Disease with Substantial Health-Related Quality of Life Impacts | | 2022 |
| Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment | | 2022 |
| Improving Development of Drug Treatments for Pregnant Women and the Fetus | Therapeutic Innovation and Regulatory Science | |
| Introductory Chapter: Biosimilars - A Regulatory and Clinical Perspective | | |
| Biocompatible magnetite nanoparticles coated with ionic liquid-based surfactant as a hydrophilic sorbent for dispersive solid phase microextraction of cephalosporins prior to their quantitation by HPTLC | Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | 2022 |
| Survival of cancer survivors with a new pancreatic cancer diagnosis | Cancer Medicine | |
| Nano-titania modified cupric-based metal organic framework for the on-line pass-through cleanup of phenothiazine drugs and metabolites in human plasma | New Journal of Chemistry | |
| Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records-a qualitative interview study in the Nordic countries. | Trials | 2022 |
| Biomarker Assay Validation by Mass Spectrometry. | AAPS Journal | 2022 |
| DataSheet_2.zip | | 2020 |
| DataSheet_1.pdf | | 2020 |
| table1.docx | | 2020 |
| DataSheet1.docx | | 2018 |
| The Sequence of Clinical Development | | |
| Randomized, Triple-Blinded, Placebo-Controlled Trial of SA3X (Spilanthes acmella) for the Management of Erectile Dysfunction. | Cureus | 2022 |
| Single and Repeated Doses of EGb 761 do not Affect Pharmacokinetics or Pharmacodynamics of Rivaroxaban in Healthy Subjects. | Frontiers in Pharmacology | 2022 |
| Lessons Learned From Translational Research in Neuromuscular Diseases: Impact on Study Design, Outcome Measures and Managing Expectation | Frontiers in Genetics | 2021 |
| A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project. | Drug Safety | 2022 |
| Vaginal Microbiota and Mucosal Pharmacokinetics of Tenofovir in Healthy Women Using a 90-Day Tenofovir/Levonorgestrel Vaginal Ring. | Frontiers in Cellular and Infection Microbiology | 2022 |
| How Does Immunomodulatory Nanoceria Work? ROS and Immunometabolism. | Frontiers in Immunology | 2022 |
| Simulation Models for Prediction of Bioavailability of Medicinal Drugs-the Interface Between Experiment and Computation. | AAPS PharmSciTech | 2022 |
| Moving Beyond the Limits of Detection: The Past, the Present, and the Future of Diagnostic Imaging in Canine Osteoarthritis. | Frontiers in Veterinary Science | 2022 |
| Systematic review reveals urgent need to homogenize endpoints choices and definitions in marginal zone lymphomas trials. | Leukemia and Lymphoma | 2022 |
| Testing the amyloid cascade hypothesis: Prevention trials in autosomal dominant Alzheimer disease. | Alzheimer's and Dementia | 2022 |
| The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder. | Journal of Psychopharmacology | 2022 |
| In Vivo Biodistribution and Pharmacokinetic Studies of NPDDS for Brain Targeting | | 2022 |
| Integrated Synthesis, Crystallization, Filtration, and Drying of Active Pharmaceutical Ingredients: A Model-Based Digital Design Framework for Process Optimization and Control | Springer Optimization and Its Applications | 2022 |
| Determination of synthetic opioids in oral fluid samples using fabric phase sorptive extraction and gas chromatography-mass spectrometry. | Journal of Chromatography A | 2021 |
| Japan Society of Clinical Oncology Clinical Practice Guidelines 2017 for fertility preservation in childhood, adolescent, and young adult cancer patients: part 1. | International Journal of Clinical Oncology | 2022 |
| Ultrasonic spray freeze-drying of sucrose and mannitol-based formulations: Impact of the atomization conditions on the particle morphology and drying performance | Drying Technology | |
| The Role of NF-kB in the Downregulation of Organic Cation Transporter 2 Expression and Renal Cation Secretion in Kidney Disease. | Frontiers in Medicine | 2021 |
| Process performance of a new liquid medication dispensing robot | European Journal of Hospital Pharmacy | 2021 |
| A Qualitative Study to Characterize the Humanistic Burden of Kabuki Syndrome in the United States and Canada | Advances in Therapy | 2021 |
| Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union. | Frontiers in Pharmacology | 2021 |
| Hypertension and Hypercholesterolemia: is it Time for Anti-«Lipitensive» Therapy? | Rational Pharmacotherapy in Cardiology | 2020 |
| External contamination of antineoplastic drug vials: an occupational risk to consider | European Journal of Hospital Pharmacy | 2020 |
| Steps in Device and Drug Pathway Development: Clinical Trials, Similarities, and Differences | Success in Academic Surgery | 2020 |
| Effect of *3 genotypes on lumefantrine plasma concentrations among malaria-HIV-infected women | Pharmacogenomics | 2020 |
| Breaking the challenge of polyherbal quality control using UV and HPLC fingerprints combined with multivariate analysis | Phytochemical Analysis | 2021 |
| Controlling for Multiplicity, Eligibility, and Exclusions | | 2020 |
| Precision Trials Informatics | | 2020 |
| International Organization of Standards for Measurement Validation: Food Analysis | | 2019 |
| Radiation Regulations, Protection, and Uses | | 2018 |
| Scientific and Regulatory Considerations for Development and Commercialization of Poorly Water-Soluble Drugs | AAPS Advances in the Pharmaceutical Sciences Series | 2016 |
| From Bench to Bedside with Targeted Therapies | | 2015 |
| Regulatory Aspects of New Medications to Treat Addictions: The U.S. IND Process | | 2015 |
| References | | |
