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Re: Pharmacogenomics

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Respected members,

Supporting factors are:

1.Once in life time testing. Cost is going to fall after some time.

2. Haplotype study (HapMap) is showing promising results.

3. FDA is planning to specify guidelines for diagnostic tests for genetic

testing.

4.Patients have to be counseled properly that genetic tests are nothing more

than normal blood tests and the tests are meant to help them.

Regards,

Dr. Amruta Dawari

JR 1, Dept of pharmacology,

GMCH, Nagpur.

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Respected members,

Pharmacogenomics & clinical trial:

The 2 most important for new drug development are efficacy & safety.

With the availability of pharmacogenomics attrition of drug compound during

clinical trial can be significantly reduced.This translates into reduction in

loss of financial resources for drug development. Also the information can help

in selecting appropriate patient for phaseI, phase II clinical trial; it can

also help in preventing side effects and abrupt termination of clinical trial.

Regards,

Dr. Amruta Dawari

JR 1, Dept of pharmacology,

GMCH, Nagpur.

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Respected members,

Different issues arise with pharmacogenomics as

Research issue: 1) Narrower target population could exclude those who might

also benefit from therapies.

2) Evaluating therapies in smaller, targeted trials might miss critical,

albeit rare, adverse drug events.

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Respected members,

There are clinical issues in front of clinicians like

1) Who should be offered testing?

2)What training or certification should be required to administer, interpret and

explain tests?

3)How should tests be integrated into the current standard of care

Regards,

Dr. Amruta Dawari

JR 1, Dept of pharmacology,

GMCH, Nagpur.

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Social issues in relation to pharmacogenomics are,

• Preventing discrimination during giving

-Insurance

-Jobs

-Educational opportunities on the basis of pharmacogenomics.

There is need of legal implications:

Regulation

Enforcement

Prosecution

Restitution

Regards,

Dr. Amruta Dawari

JR 1, Dept of pharmacology,

GMCH, Nagpur.

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Respected members,

Economical issues in relation to pharmacogenomics are

Unknown Costs of :

1)Pharmacogenomics testing

2)Unnecessary preventative interventions by individuals (e.g., surgery,

prophylaxis, etc.)

Regards,

Dr. Amruta Dawari

JR 1, Dept of pharmacology,

GMCH, Nagpur.

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