CLINICAL RESEARCH

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15 pitfalls and how to avoid them in clinical reseach

Getting a new drug approved is becoming more difficult. Although the FDA has gotten better at approving drugs and approving them faster,...
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 report...
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. Comp...
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 t...
Adverse Events in Clinical Research

Adverse Events in Clinical Research
SECTOR PROFILE Clinical Research

The US$ 64 billion global clinical research industry is witnessing a transition since lifescience companies are turning toward emerging ma...
The IMPORTANCE of PHARMACOVIGILANCE

Safety Monitoring of medicinal products The purpose of this document is: • to present the case for the importance of pharmacovigilanc...
Common Pitfalls in Multinational Clinical Trials

Multinational clinical trials are challenging. The international industry is rapidly maturing, but horror stories are still common: “...
The SAFETY of MEDICINES IN PUBLIC HEALTH PROGRAMMES:

Pharmacovigilance an essential tool Public health is deﬁned as the organized efforts of society to protect, promote and restore people’s...
Declaration of Helsinki

World Medical Association Declaration of Helsinki The World Medical Association has developed the Declaration of Helsinki as a statement...

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