Clinical Research Practices and Drug Regulatory Affairs

Title Publication Date Language Citations
Statistical Methods for Bioavailability and Bioequivalence1983/01/01English26
Comparison of Efficacy of Ginger with Various Antimotion Sickness Drugs1988/01/01English14
Analytical Methods used in Bioavailability Studies: A Regulators Viewpoint1987/01/01English10
Current Thoughts on Crossover Designs1986/01/01English8
Social Forces in the Premature Removal of Drug Products from the Marketplace1987/01/01English7
Adverse Consequences of Chemical Immunomodulation1985/01/01English7
Biopharmaceutic Considerations in Designing and Evaluating Novel Drug Delivery Systems1985/01/01English5
Dse and Limitations of the Truncated Area Under the Curve in Bioequivalence Testing1990/01/01English4
The Process of Drug Development: I. The Historical Interplay of Political Economics, Research and Regulation1983/01/01English3
A Centrally Organized Approach to Clinical Research in a University Medical Center Administered by Clinical Pharmacists1986/01/01English2
FDA Audits of Clinical Investigators1985/01/01English2
The Process of Drug Development: II. The Historical Interplay of Therapeutics, Clinical Research, and Scientific Education1983/01/01English2
Spontaneous Reporting of Adverse Drug Reactions: Assessment of Physician Knowledge and Attitudes Before and after the Intervention of a State Health Agency1990/01/01English2
Innovative Roles for Pharmacists in Industrial Clinical Research1986/01/01English2
A Geocentric Approach to Pharmaceutical Research and Development and Drug Regulatory Affairs1985/01/01English2
A Guide for Clinical Studies with Potential Antipsychotic Or Antidepressant Medications1988/01/01English2
Project Management in the Pharmaceutical Industry1983/01/01English1
The Role of Fda's Orphan Products Development Program in the Facilitation of Development of orphan drugs and other Products; Implementation of the Orphan Drug act1984/01/01English1
Facts, Fiction, and the Pharmaceutical Industry1986/01/01English1
Haloperidol Induced Neuroleptic Malignant Syndrome1986/01/01English1
Pharmaceutical Clinical Scientists: An Opportunity for the Pharmaceutical Industry1983/01/01English1
Objective Claims Substantiation for Cosmetic and Pharmaceutical Products, Based Upon Measurement of Sensory, Perceptual, Analgesic, Pruritic, and Irritative Effects1986/01/01English1
FDA-State Projects to Improve Reporting of Adverse Drug Reactions1990/01/01English1
Micro/Macro Strategies for Improving Hospital Formulary Performance1984/01/01English1
A Perspective on the Cost-Benefit of Drug Therapy1985/01/01English1
Pseudo-Allergic Drug Reactions1986/01/01English1
Prevalence of Abnormal Liver function Tests in Laboratory Workers1983/01/01English1
FDA Regulatory Affairs: An Overview for Nurses in Clinical Research1984/01/01English1
Introduction1987/01/01English1
The Investigator's Brochure as a Tool for the Development of the Package Insert1985/01/01English1