| Effectiveness of Hemopatch® versus Surgicel® Original to control mild and moderate liver bleeding | | 2022 |
| Regulatory Aspects for Assay Development, Validation, and Sample Analysis | | 2022 |
| Scientific and Regulatory Policy Committee Points to Consider: Primary Digital Histopathology Evaluation and Peer Review for Good Laboratory Practice (GLP) Nonclinical Toxicology Studies | Toxicologic Pathology | |
| 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). | Bioanalysis | 2022 |
| Preclinical Studies: Efficacy and Safety | | 2018 |
| Kosten-Nutzen-Analyse und Aspekte der Ergebnisqualität von eSource in der klinischen Forschung | | 2017 |
| Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection | | 2016 |
| Interferon Gamma Enzyme-Linked Immunosorbent Spot Assay | | |
| Clinical Applications of HIV Gene Therapy | SpringerBriefs in Biochemistry and Molecular Biology | 2014 |
| Safety Pharmacology in Drug Discovery and Development | Handbook of Experimental Pharmacology | 2015 |
| Data Quality in Clinical Research | | 2012 |
| Setting Quality Standards for Stem Cell Banking, Research and Translation: The International Stem Cell Banking Initiative | Pancreatic Islet Biology | 2014 |
| 2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos) | Bioanalysis | 2021 |
| Preliminary and evaluation of specific activity of branched oligohexamethyleneguanidine hydrochloride | Drug Development and Industrial Pharmacy | 2020 |
| Safety evaluation of the interchangeable use of robenacoxib in commercially-available tablets and solution for injection in cats | BMC Veterinary Research | 2020 |
| Data Quality in Clinical Research | | 2019 |
| The Clinical Translation Process in the United States | | 2019 |
| Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices | Toxicologic Pathology | 2018 |
| Biologics | | 2018 |
| Nonclinical comparability studies of recombinant human arylsulfatase A addressing manufacturing process changes | PLoS ONE | 2018 |
| Pharmacokinetics of a Long-Acting Nanoformulated Dolutegravir Prodrug in Rhesus Macaques | Antimicrobial Agents and Chemotherapy | 2018 |
| Safety evaluation of the interchangeable use of robenacoxib (Onsior™) tablets and solution for injection in dogs | BMC Veterinary Research | 2017 |
| Juvenile Toxicology Testing | | 2017 |
| Smart Documentation Strategies | | 2016 |
| Metabolism and Disposition of Aditoprim in Swine, Broilers, Carp and Rats | Scientific Reports | 2016 |
| Safety evaluation of the human-identical milk monosaccharide, l-fucose | Regulatory Toxicology and Pharmacology | 2015 |
| Research in Laboratory Animal and Comparative Medicine | | 2015 |
| Manufacturing process used to produce long-acting recombinant factor VIII Fc fusion protein | Biologicals | 2015 |
| Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial | Cytotherapy | 2015 |
| Bioprinting of Dynamic Human Organs-on-Chips: Enabling Technologies for Rapid Drug Development and Personalized Medicine | Pancreatic Islet Biology | 2015 |
| Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology | Toxicologic Pathology | 2015 |
| Development of Vaccines for Microbial Diseases | | 2014 |
| HPLC im Reglementierten Bereich | | 2014 |
| Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein | Haemophilia | 2014 |
| Medical Devices | | 2014 |
| Food Safety Assurance Systems: Quality Assurance and Good Laboratory Practice | | 2014 |
| Transcatheter occlusion of the patent ductus arteriosus in infants: experimental testing of a new Amplatzer device | Catheterization and Cardiovascular Interventions | 2014 |
| A cross-sectional analysis of candidate biomarkers of biological effect in smokers, never-smokers and ex-smokers | Biomarkers | 2014 |
| Safety evaluation of the human-identical milk monosaccharide sialic acid (N-acetyl-d-neuraminic acid) in Sprague-Dawley rats | Regulatory Toxicology and Pharmacology | 2014 |
| Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries | Veterinary Clinical Pathology | 2013 |
| Animal Models for Cardiac Valve Research | | 2013 |
| Regulatory Inspection Trends and Findings of Bioanalytical Laboratories | | 2013 |
| Nonclinical Regulatory Aspects for Ophthalmic Drugs | Molecular and Integrative Toxicology | 2012 |
| Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets | British Journal of Pharmacology | 2012 |
| Mapping and Characterizing the Development Pathway from Non-Clinical through Early Clinical Drug Development | Pharmaceutical Medicine | 2012 |
| Phytochemistry and traditional medicine – A revolution in process | Phytochemistry Letters | 2011 |
| Development and validation of a quantitative cell-based bioassay for comparing the pharmacokinetic profiles of two recombinant erythropoietic proteins in serum | Journal of Pharmaceutical and Biomedical Analysis | 2007 |
