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Writing Research Protocols in Pharmacological Studies

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Abstract

The effects of drugs or chemicals are studied at every plausible level of complexity involving pure proteins, cells in tissue culture, intact isolated tissue, in situ perfused organs, and intact animals, including normal, surgically modified, and transgenic animals. Each of these models has its own protocols, methodologies, techniques, and data analyses. The research protocol is a roadmap for research that graduate students and early-career researchers can use to build track records and expertise in their fields. It is developed by integrating a multitude of ideas that emanate from the identification of a knowledge gap found while conducting a literature search. Next, it is processed into selection of a research topic of interest, followed by asking intriguing research questions, and the development of hypotheses and objectives. This chain of procedures described in the research protocol follows a well-organized plan of study that forms the basis of a clinical investigation or exploration of cellular mechanisms and molecular targets for potential new chemical entities. The protocol also describes the study background, rationale, and significance; design and methods; and data analysis using the right kinds of statistical tests, among others, within a clinical trial or an experimental study. It is designed to provide a satisfactory answer to the research question. In effect, the protocol is a written reminder of things to do when conducting the study. In this chapter, we describe a systematic and step-by-step approach to planning research protocols, including five examples at three levels of complexity in a hierarchical manner from cells to intact animals.

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Acknowledgments

We wish to thank Joanne Berger, FDA Library, for having critically read and edited the draft of the manuscript.

Conflict of Interest

None.

Disclaimer

This article reflects the views of GJ and should not be construed to represent US FDA’s views or policies.

Author information

Authors and Affiliations

  1. Retired Senior Expert Pharmacologist at the Office of Cardiology, Hematology, Endocrinology, and Nephrology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Gowraganahalli Jagadeesh

  2. Distinguished Visiting Professor at the College of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru, Karnataka, India

    Gowraganahalli Jagadeesh

  3. Visiting Professor at the College of Pharmacy, Adichunchanagiri University, BG Nagar, Karnataka, India

    Gowraganahalli Jagadeesh

  4. Visiting Professor at the College of Pharmaceutical Sciences, Manipal Academy of Higher Education (Deemed-to-be University), Manipal, Karnataka, India

    Gowraganahalli Jagadeesh

  5. Senior Consultant & Advisor, Auxochromofours Solutions Private Limited, Silver Spring, MD, USA

    Gowraganahalli Jagadeesh

  6. Professor & Director, Research Training and Publications, The Office of Research and Development, Periyar Maniammai Institute of Science & Technology (Deemed to be University), Vallam, Tamil Nadu, India

    Pitchai Balakumar

Authors
  1. Gowraganahalli Jagadeesh
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Corresponding author

Correspondence to Gowraganahalli Jagadeesh .

Editor information

Editors and Affiliations

  1. Retired Senior Expert Pharmacologist at the Office of Cardiology, Hematology, Endocrinology, and Nephrology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Gowraganahalli Jagadeesh

  2. Professor & Director, Research Training and Publications, The Office of Research and Development, Periyar Maniammai Institute of Science & Technology (Deemed to be University), Vallam, Tamil Nadu, India

    Pitchai Balakumar

  3. Division Cardiology & Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Fortunato Senatore

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Jagadeesh, G., Balakumar, P. (2023). Writing Research Protocols in Pharmacological Studies. In: Jagadeesh, G., Balakumar, P., Senatore, F. (eds) The Quintessence of Basic and Clinical Research and Scientific Publishing. Springer, Singapore. https://doi.org/10.1007/978-981-99-1284-1_4

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