Design of a Personalized Nasal Device (Matrix-Piston Nasal Device, MPD) for Drug Delivery: a 3D-Printing Application | | 2022 |
Comparative pharmacokinetics of four major flavonoids in normal and chronic gastritis rats after oral administration of different combinations of Banxia Xiexin Decoction | Biomedical Chromatography | |
Facile electrochemical detection of morpholine in boiler water with carbon nanostructures: a comparative study of graphene and carbon nanotubes | Bulletin of Materials Science | 2022 |
Assessment of Resonant Acoustic Mixing for Low-Dose Pharmaceutical Powder Blends. | AAPS PharmSciTech | 2022 |
Optimization of enzymatic synthesis of theaflavins from potato polyphenol oxidase. | Bioprocess and Biosystems Engineering | 2022 |
Organization of the Clinical Trial by the Sponsor | | |
Pharmacokinetic Modeling Program (PKMP): A Software for PK/PD Data Analysis | | 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 |
Determination of Eupatilin in Human Plasma by High-Performance Liquid Chromatography?Tandem Mass Spectrometry | Chromatographia | |
Development of Pharmacodynamic Biomarkers for Phase I Trials | | 2020 |
South Africa | AAPS Advances in the Pharmaceutical Sciences Series | 2017 |
Pharmacokinetic Studies to Support Clinical Trials: From Scientific Perspective. | Drug Metabolism and Pharmacokinetics | 1999 |
Immunotoxicology of Biopharmaceutics☆ | | 2014 |
Exposure–Response Relationships of Anticancer Agents: Application in Drug Development and Drug Label | Cancer Drug Discovery and Development | 2014 |
In Vitro Assessment of the Reactivity of Acyl Glucuronides | Methods in Pharmacology and Toxicology | 2014 |
Planning for Data Monitoring and Audits | Success in Academic Surgery | 2014 |
Clinical Pharmacology Strategies in the Development of Antibody–Drug Conjugates | | 2013 |
Translational Research in Alzheimer’s Disease for Development of Antibody-Based Therapeutics | | 2012 |
Reinraumanlagen für Mikroelektronik und Pharma | | 2012 |
Regulatory Considerations in Product Development for Back of the Eye | AAPS Advances in the Pharmaceutical Sciences Series | 2011 |
Drug Discovery and Evaluation: Methods in Clinical Pharmacology | | 2011 |
Nonclinical Safety Evaluation Studies Conducted to Support Continued Clinical Development | | 2011 |
Regulatory Requirements for INDs/FIH (First in Human) Studies | | |
Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective | | |
Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP) | | |
Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies | | |
In Vitro Mammalian Cell Mutation Assays | | |
Review Boards | | |
Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals | | |
Drug Impurities and Degradants and Their Safety Qualification | | |
Designing and Conducting Phase III Studies | | |
Regulatory Approval | | |
Regulatory Issues in Preclinical Safety Studies (U.S. FDA) | | |
Regulation of Human Pharmaceutical Safety | | |
Regulations | | |
National GMP Regulations and Codes and International GMP Guides and Guidelines: Correspondences and Differences | | |
Ethical Implications of Psychopharmacotherapy | International Library of Ethics, Law, and the New Medicine | 2010 |
Topical Therapies for Nonmelanoma Skin Cancers | | 2009 |
DRUG DEVELOPMENT | | 2009 |
Radiopharmaceuticals: Drug Development and Regulatory Issues | | 2009 |
Educational Strategies in Genomic Medicine | | 2009 |
Biologic, Chemical, and Radiologic Terrorism | | 2007 |
Release, Dissolution and Permeation | | 2006 |
Release, Dissolution, and Permeation | | 2006 |
Common Technical Document | | 2006 |
Managing Data in High Throughput Laboratories: An Experience Report from Proteomics | Lecture Notes in Computer Science | 2006 |
Chapter 1 | | 2004 |
A Regulatory View of Liposomal Drug Product Characterization | | 2004 |
Bisphosphonate Therapy for Postmenopausal Osteoporosis | | 2004 |
Adverse Reproductive Outcome Potential of Cancer Therapies During Pregnancy | | 2001 |