Clinical Research and Regulatory Affairs

Aims & Scope

Cessation.

Clinical Research and Regulatory Affairs is a peer-reviewed international journal whose primary aim is the dissemination of knowledge about the issues and challenges of clinical research, with a special emphasis on the design, conduct, analysis, synthesis, history, ethics, regulation, and clinical and policy aspects of drug development.

The journal is committed to the rapid communication of original, scientific, and statistically significant results that pertain to advancements in clinical research and regulatory approaches appropriate for advancing drug development.

Each issue will provide in-depth analyses of a key problem area in developing a regulatory initiative.

The scope of Clinical Research and Regulatory Affairs includes methods for designing, analyzing, and interpreting scientific research results and harmonizing drug development.

The journal invites these discussions in the form of original articles, comprehensive commentaries, or in-depth reviews of research methodologies that explore the evolving paradigm for regulating drug and biological products.

Abstracting & Indexing

Journal is indexed in leading academic databases, ensuring global visibility and accessibility of our peer-reviewed research.

• Scopus
• Google Scholar

Subjects & Keywords

Journal’s research areas, covering key disciplines and specialized sub-topics in Medicine and Pharmacology, Toxicology and Pharmaceutics, designed to support cutting-edge academic discovery.

Most Cited Articles

The Most Cited Articles section features the journal's most impactful research, based on citation counts. These articles have been referenced frequently by other researchers, indicating their significant contribution to their respective fields.

• Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel

  Citation: 236

  Authors: F., M. A., C. K., A. R., P., J., S., N., W., N. J., M., K., H., P., D. M., W. J., J., A., C. H., G., P. S., M.

• Design of Experiments: Concept and Applications of Plackett Burman Design

  Citation: 195

  Authors: K., R.H.

• Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol

  Citation: 115

  Authors: Heejung, Stephen P., Jafar, Jongbae

• Classification of Drug Permeability with a Caco-2 Cell Monolayer Assay

  Citation: 77

  Authors: Donna A., Patrick J., Anthony B., Ebenezer B., Christopher D., Lawrence X., Ajaz S.

• Assessment of internet gaming disorder in clinical research: Past and present perspectives

  Citation: 76

  Authors: Halley M., Mark D.

• An Invisible Population: Older Lesbian, Gay, Bisexual, and Transgender Individuals

  Citation: 57

  Authors: Michael D., Charles A., Esther S., Stewart

• BIOCHEMICAL ROLE OF FOLATE IN CELLULAR METABOLISM*

  Citation: 47

  Authors: Conrad

• Special population considerations and regulatory affairs for clinical research

  Citation: 45

  Authors: Kristin N., Catherine M. T., Jonathan E., Casey, Athena F., Michael G., Nicole L.

• Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system

  Citation: 44

  Authors: Saroj, Xiaoling, Peter, Mary-Anne, Rick, Nina, Ping, Cesar, Bhaskara

• International Harmonization of Regulatory Bioequivalence Requirements

  Citation: 38

  Authors: V. W., D.