Adverse Events in Clinical Research

Adverse Events in Clinical Research

Safety Reporting Requirements for INDs and BA/BE Studies

This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3).  This document provides guidance to sponsors and investigators on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of BA and BE studies that are exempt from the IND requirements.  This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators. 

DRUG DISCOVERY AND DEVELOPMENT

Dosage Form Design: Pharmaceutical and Formulation Considerations

After reading this chapter, the student will be able to:
1. List reasons for the incorporation of drugs into various dosage forms
2. Compare and contrast the advantages/disadvantages of various drug dosage forms
3. Describe the information needed in preformulation studies to characterize a drug substance for possible inclusion into a dosage form
4. Describe the mechanisms of drug degradation and provide examples of each
5. Describe the fi ve types of drug instability of concern to the practicing pharmacist
6. Summarize approaches employed to stabilize drugs in pharmaceutical dosage forms
7. Calculate rate reactions for various liquid dosage forms
8. Categorize various pharmaceutical ingredients and excipients

Clinical Research Lectures

ETHICS IN CLINICAL RESEARCH

The health care team involved in research is ethically bound to respect human life and peoples’
autonomy. Good research practice demands that researchers must respect the rights of their subjects, listen to and share information with them, and treat them courteously and caringly.
Ethics refers to moral principles governing human character and conduct. The principles of medical ethics, introduced by Beauchamp and Childress in 1979, are as much relevant to the medical research as they are to healthcare.

Declaration of Helsinki

World Medical Association Declaration of Helsinki

The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.