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Contents

► Prefatory: Clinical Trial

► Field of Significance

► Phases of Clinical Trial

► Individual Elaboration

► Diagram (Summary)

► Economics

► Conclusion

► Bibliography & References

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Prefatory

Clinical trial is defined as the predetermined (Planned) experiment designed

to evaluate the result of different mode of treatments on human being.

Criteria

► Safe & effective

► Drug development

► Specific protocols

Categories

► Randomized

► Blind

► Placebo (Dummy Pill) controlled

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Field of Significance

◘ Safety & Tolerance level determination

◘ Evaluation of Pharmacokinetic profile of the drug

◘ Bioavailability study

◘ Draw the Pharmacological profile of the drug

Points to Ponder

► Clinical Trial is a team work

► Safety is the first demand of the protocol (Clinical Trial)

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Phases of Clinical Trial

► Pre – Clinical Phase

►Clinical Phase

CLINICAL PHASE

PHASE - I PHASE - II PHASE - III

► Post Marketing Surveillance (Trial)

Usually this phase is known as Post Approval Trial (Phase – IV).

Includes a number of approaches

It holds a position in the science of Pharmacovigilance

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Individual Documentary

► Pre – Clinical Phase (Animal Study)

Synonymous Terminology: Non – Clinical or Safety Assessment Stage

Outcomes are submitted to the Drug Regulatory Authority

Determinant of the product’s ultimate Safety Profile

► Phase – I (Operated by a Clinical Researcher)

Participants: 20 – 100 Volunteers

◘ Phase – I a
Human Trial

◘ Phase – I b

This sub – phase is concerned with the safety of healthy human

► Phase – II

◘ Phase – II a

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Involves the potential efficacy & safety of the drug

◘ Phase – II b

Dose & dosage regimen are usually determined

► Phase – III

◘ Phase – III a

NDA pass or not

◘ Phase – III b

Launching a decision

► Phase – IV (PMS)
This approach is performed after the release of the product in the market. It also provides
additional information, including the drug's risks, benefits, and optimal use.

During the operation of this phase any drug can be banned out of the market due to
objectionable pharmacokinetic and pharmacodynamic evidence

ABBREVIATIONS USED IN THE PAGE

NDA – New Drug Approval

PMS – Post Marketing Surveillance

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► Diagram (Recap)

► Economics

Sponsors play a monetary role in the entire protocol (Investors).

Drug Design & Discovery is 10 – 15 years coursework (Requires economical backup)

► Conclusion

This was a trivial approach to illustrate the clinical trial. I have tried to focus the very
basic items of the given assignment.

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► References & Bibliography

ACKNOWLEDGEMENT CORNER

It was my noticeable privilege to have the

class outlines (11 Jul. 12) provided by the
course instructor Mr. Abdul Motaleb Bhuiyan
(Medicinal Chemistry – II, PHR – 402)

Additionally, I name the following resources –

◘ References

www.google.com

www.wikipedia.com

www.myclin.com

◘ Bibliography

Foye’s Principles of Medicinal Chemistry

Burger’s Medicinal Chemistry & Drug Discovery

Fundamentals of Clinical Trials – Lawrence M. Friedman

THE END

Asif Mahmood