What is an ideal drug In the early

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What is an ideal drug? In the early 1900 s Paul Ehrlich described an

What is an ideal drug? In the early 1900 s Paul Ehrlich described an ideal drug as a magic bullet. . Such a drug would be aimed precisely at a disease site and would not harm healthy tissues.

Limitations of Clinical Trials Limited size Ø Narrow population Ø Narrow indications Ø Short

Limitations of Clinical Trials Limited size Ø Narrow population Ø Narrow indications Ø Short duration Ø Ref: J. Russell May. Adverse drug Reactions and interaction, In: Pharmacotherapy, A pathophysiologic Approach. 1997, Appleton & Lange.

Detection, Assessment & Prevention of ADRs in Human. Ref: World Health Organization.

Detection, Assessment & Prevention of ADRs in Human. Ref: World Health Organization.

The ultimate goal of pharmacovigilance is improving pharmacotherapy

The ultimate goal of pharmacovigilance is improving pharmacotherapy

The FDA Safety Information and Adverse Med. Watch Event Reporting Program: www. fda. gov/medwatch/

The FDA Safety Information and Adverse Med. Watch Event Reporting Program: www. fda. gov/medwatch/ Safety alerts Recalls Withdrawals Important labeling changes Biologicals, Drugs, Dietary supplements

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