| Table_5.docx | | 2019 |
| Table_4.docx | | 2019 |
| Table_3.docx | | 2019 |
| Table_2.docx | | 2019 |
| Table_1.docx | | 2019 |
| Data_Sheet_1.PDF | | 2018 |
| Chapter 9 Nanomaterials and Nanotechnologies for Photon Radiation Enhanced Cancer Treatment | NATO Science for Peace and Security Series B: Physics and Biophysics | 2018 |
| Arzneiverordnungen 2014 im Überblick | | 2015 |
| Readability Analysis of the Package Leaflets for Biological Medicines Available on the Internet Between 2007 and 2013: An Analytical Longitudinal Study | Journal of Medical Internet Research | 2016 |
| Adverse Drug Reactions with HER2-Positive Breast Cancer Treatment: An Analysis from the Italian Pharmacovigilance Database | Drugs - Real World Outcomes | 2021 |
| Changes in Multimorbidity and Polypharmacy Patterns in Young and Adult Population over a 4-Year Period: A 2011-2015 Comparison Using Real-World Data | International Journal of Environmental Research and Public Health | 2021 |
| Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval | British Journal of Clinical Pharmacology | 2020 |
| A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA | Therapeutic Innovation and Regulatory Science | 2019 |
| Safety and Tolerability of Phosphatidylinositol-3-Kinase (PI3K) Inhibitors in Oncology | Drug Safety | 2019 |
| Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology | Drug Safety | 2019 |
| Patterns of multimorbidity and polypharmacy in young and adult population: Systematic associations among chronic diseases and drugs using factor analysis | PLoS ONE | 2019 |
| Safety assessment of anticancer drugs in association with radiotherapy in metastatic malignant melanoma: a real-life report : Radiation/systemic drug combo in metastatic melanoma | Cancer Chemotherapy and Pharmacology | 2019 |
| Global Disparities: Can the World Afford Cancer? | | 2019 |
| Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol | Drug Safety | 2019 |
| HIV care cost in England: a cross-sectional analysis of antiretroviral treatment and the impact of generic introduction | HIV Medicine | 2019 |
| Complexity of Biologics CMC Regulation | | 2019 |
| Research and development of mAb drugs in China: a look from policy perspectives | Human Vaccines and Immunotherapeutics | 2019 |
| Readability assessment of package leaflets of biosimilars | BMJ Open | 2019 |
| Healthcare resource utilization and costs for multiple sclerosis management in the Campania region of Italy: Comparison between centre-based and local service healthcare delivery | PLoS ONE | 2019 |
| Copies of nonbiological complex drugs: generic, hybrid or biosimilar? | Drug Discovery Today | 2019 |
| Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS) | BioDrugs | 2018 |
| Anti-Tumor Necrosis Factor α Therapeutics Differentially Affect Infection of Human Macrophages | Frontiers in Immunology | 2018 |
| Parenteral protein formulations: An overview of approved products within the European Union | European Journal of Pharmaceutics and Biopharmaceutics | 2018 |
| Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust | Oncologist | 2018 |
| Appendix 3—Marketed Biotherapeutics | | 2018 |
| Selected Biotherapeutics Overview | | 2018 |
| Availability and Affordability of Drugs With a Conditional Approval by the European Medicines Agency; Comparison of Korea With Other Countries and the Implications | Frontiers in Pharmacology | 2018 |
| [Predictive value of PD-L1 diagnostics] | Der Pathologe | 2018 |
| "Market withdrawals" of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations | Health Economics Review | 2018 |
| Drug Interactions With New Synthetic Opioids | Frontiers in Pharmacology | 2018 |
| EU Perspective on Biosimilars | AAPS Advances in the Pharmaceutical Sciences Series | 2018 |
| Anti-tumor necrosis factor agents in Crohn's disease and ulcerative colitis: Beyond luminal disease | Gastroenterología Y Hepatología | 2018 |
| Pharmacogenetic studies with oral anticoagulants. Genome-wide association studies in vitamin K antagonist and direct oral anticoagulants | Oncotarget | 2018 |
| Anti-tumour necrosis factor agents in Crohn's disease and ulcerative colitis: Beyond luminal disease | Gastroenterología Y Hepatología (English Edition) | 2018 |
| Recommendations for the design of small population clinical trials | Orphanet Journal of Rare Diseases | 2018 |
| Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany | Value in Health | 2018 |
| Sample Size for Multiple Hypothesis Testing in Biosimilar Development | Statistics in Biopharmaceutical Research | 2018 |
| Portrait of women with type 1 or type 2 diabetes of childbearing age attending diabetes clinics in Italy: the AMD-Annals initiative | Acta Diabetologica | 2018 |
| Quantitative Estimation of Plasma Free Drug Fraction in Patients With Varying Degrees of Hepatic Impairment: A Methodological Evaluation | Journal of Pharmaceutical Sciences | 2018 |
| Conflicting meal recommendations for oral oncology drugs: pose risks to patient care? | European Journal of Clinical Pharmacology | 2018 |
| Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms | Pharmacology & Therapeutics | 2018 |
| Anticoagulant prophylaxis and therapy in children: current challenges and emerging issues | Journal of Thrombosis and Haemostasis | 2018 |
| Immunogenicity Assessment of Biosimilars | Pharmaceutical Medicine | 2018 |
| An F-Labeled Poly(ADP-ribose) Polymerase Positron Emission Tomography Imaging Agent | Journal of Medicinal Chemistry | 2018 |
| Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis | Arthritis Care and Research | 2018 |
| Differential clinical presentation of Adamantiades-Behçet's disease in non-endemic and endemic areas: retrospective data from a Middle-European cohort study | International Journal of Rheumatic Diseases | 2018 |
| Epigenetics and Down syndrome | | 2017 |
| GLP-1 and the kidney: from physiology to pharmacology and outcomes in diabetes | Nature Reviews Nephrology | 2017 |
| Challenges With the Development of Biosimilars in Asia for Western Markets: An Overview and Suggested Solutions | Therapeutic Innovation and Regulatory Science | 2017 |
| Theoretical study of the deposition and adsorption of bisphosphonates on the 001 hydroxyapatite surface: Implications in the pathological crystallization inhibition and the bone antiresorptive action | Applied Surface Science | 2017 |
| Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective | Saudi Pharmaceutical Journal | 2017 |
| An Interactive Mobile Phone-Website Platform to Facilitate Real-Time Management of Medication in Chronically ill Patients | Journal of Medical Systems | 2017 |
| Availability and quality of illegitimate somatropin products obtained from the Internet | International Journal of Clinical Pharmacy | 2017 |
| Impact of Guidance on the Prescription Patterns of G-CSFs for the Prevention of Febrile Neutropenia Following Anticancer Chemotherapy: A Population-Based Utilization Study in the Lazio Region | BioDrugs | 2017 |
| New insights into human farnesyl pyrophosphate synthase inhibition by second-generation bisphosphonate drugs | Journal of Computer-Aided Molecular Design | 2017 |
| Guidance to develop individual dose recommendations for patients on chronic hemodialysis | Expert Review of Clinical Pharmacology | 2017 |
| Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community | BioDrugs | 2017 |
| Use of Systemic Therapy Concurrent With Cranial Radiotherapy for Cerebral Metastases of Solid Tumors | Oncologist | 2017 |
| Characterization of the Recent Postmarketing Safety Measures in Europe Focusing on Additional Pharmacovigilance Activities | Pharmaceutical Medicine | 2017 |
| Interchangeability of Biosimilars: A European Perspective | BioDrugs | 2017 |
| Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland | Value in Health | 2017 |
| Tyrosine Kinase Inhibitors and Proton Pump Inhibitors: An Evaluation of Treatment Options | Clinical Pharmacokinetics | 2017 |
| Nanopharmaceuticals: Tiny challenges for the environmental risk assessment of pharmaceuticals | Environmental Toxicology and Chemistry | 2016 |
| Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices | BioDrugs | 2016 |
| Burden of Moderate-to-Severe Plaque Psoriasis and New Therapeutic Approaches (Secukinumab): An Italian Perspective | Dermatology and Therapy | 2016 |
| Oral antineoplastic agent interactions with medicinal plants and food: an issue to take into account | Journal of Cancer Research and Clinical Oncology | 2016 |
| Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany - are additional data requirements by the Federal Joint Committee justified? | Health Economics Review | 2016 |
| EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets - a primer for academic researchers | BMC Medical Research Methodology | 2016 |
| Can Registration Procedures of Pharmaceuticals Inadvertently Contribute to Off-Label Prescribing in Children? | Therapeutic Innovation and Regulatory Science | 2016 |
| The opportunities and challenges of biosimilar orphans | Expert Opinion on Orphan Drugs | 2016 |
| HPV-Impfungen für Mädchen und Jungen | Monatsschrift Fur Kinderheilkunde | 2016 |
| An assessment of implications of adaptive licensing for pharmaceutical intellectual property and regulatory exclusivity rights in the European Union | Clinical Pharmacology and Therapeutics | 2016 |
| Regulatory approval pathways for anticancer drugs in Japan, the EU and the US | International Journal of Hematology | 2016 |
| Investigational drugs for treating agitation in persons with dementia | Expert Opinion on Investigational Drugs | 2016 |
| Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents | BMJ Open | 2016 |
| Serious adverse drug events related to non-investigational drugs in academic clinical trials: another source of safety data for risk assessment? | British Journal of Clinical Pharmacology | 2016 |
| Pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of monoclonal antibodies in children | Clinical Pharmacokinetics | 2015 |
| [GESIDA/National AIDS Plan: Consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (Updated January 2015)] | Enfermedades Infecciosas Y Microbiología Clínica | 2015 |
| [Regulatory aspects of biosimilars. Myths and facts] | Zeitschrift Fur Rheumatologie | 2015 |
| The therapeutic monoclonal antibody market | MAbs | 2015 |
| A Systematic Review of the Cost-Effectiveness of Biologics for the Treatment of Inflammatory Bowel Diseases | PLoS ONE | 2015 |
| Analysis and Breakdown of Overall 1-Year Costs Relative to Inpatient and Outpatient Care Among Rheumatoid Arthritis Patients Treated with Biotherapies Using Health Insurance Claims Database in Alsace | Drugs - Real World Outcomes | 2015 |
| [GeSIDA/National AIDS Plan: Consensus document on antiretroviral therapy in adults infected by the human immunodeficiency virus (Updated January 2014)] | Enfermedades Infecciosas Y Microbiología Clínica | 2014 |
| Questioning patient subgroups for benefit assessment: challenging the German Gemeinsamer Bundesausschuss approach | Value in Health | 2014 |
| European Medicines Agency initiatives and perspectives on pharmacogenomics | British Journal of Clinical Pharmacology | 2014 |
| Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation | European Journal of Health Economics | 2014 |
| [Phase IV non-interventional studies in the treatment of rheumatoid arthritis with biologicals in Germany : real-life clinical practice data] | Zeitschrift Fur Rheumatologie | 2014 |
| Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis | Applied Health Economics and Health Policy | 2014 |
| The impact of legislation on drug substances used off-label in paediatric wards--a nationwide study | European Journal of Clinical Pharmacology | 2014 |
| Tratamiento biológico de la artritis reumatoide en España. Análisis de impacto presupuestario de la utilización de certolizumab pegol | Pharmacoeconomics - Spanish Research Articles | 2014 |
| [Shift of focus in the financing of Hungarian drugs. Reimbursement for orphan drugs for treating rare diseases: financing of enzyme replacement therapy in Hungary] | Orvosi Hetilap | 2014 |
| Exploring Ethnic Differences in Toxicity in Early-Phase Clinical Trials for Oncology Drugs | Therapeutic Innovation and Regulatory Science | 2014 |
| How does HIV affect the reproductive choices of women of childbearing age? | Antiviral Therapy | 2013 |
| Pulmonary complications of biological therapies in children and adults with rheumatic diseases | Paediatric Respiratory Reviews | 2013 |
| Quantitative prediction of the impact of drug interactions and genetic polymorphisms on cytochrome P450 2C9 substrate exposure | Clinical Pharmacokinetics | 2013 |
