Drug discovery and development

1. Explain the significance of in vitro/ in vivo toxicity studies in establishing the safety of new drugs.

2. Describe the methods and principles underlying various toxicological tests (in vivo/ in vitro).

3. Discuss the ethical requirements in the conduct of animal and human testing.

4. Describe the guidelines in the ethical conduct in the care and use of animals and humans in drug
testing.

Ans)

The cost impact of late-stage failures of drug candidates has

motivated the pharmaceutical industry to develop, validate, and implement

a more proactive testing paradigm, including an emphasis on conducting predictive

in vitro and in vivo studies earlier. The goal of drug discovery toxicology is not

to reduce or eliminate attrition, as is often mis-stated as such, but rather to

reprioritize efforts to shift attrition of future failing molecules upstream in

discovery. This shift in attrition requires additional studies and investment

earlier in the candidate evaluation process in order to avoid spending resources

on molecules with soon-to-be-discovered development-limiting liabilities.

While in silico and in vitro models will continually be developed and refined,

in vivo preclinical safety models remain the gold standard for assessing human risk.

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 For in vivo testing to influence early discovery effectively, it must:

i) require low amounts of compound;

ii) provide rapid results to drive decision-making and medicinal chemistry efforts;

and iii) be flexible and provide results relevant to the development plan tailored

to each target, drug class, and/or indication.

2.) In vitro (literally 'in glass') testing methods are employed primarily to identify

potentially hazardous chemicals and/or to confirm the lack of certain toxic properties

in the early stages of the development of potentially useful new substances such as

therapeutic drugs, agricultural chemicals and food additives.

3) Ethical Guidelines for the Use of Animals in Research:

Respect for animals' dignity.

Responsibility for considering options (Replace)

The principle of proportionality: responsibility for considering and

balancing suffering and benefit.

4) The APA ethics code outlines standards for safeguarding human participants'

well-being, including obtaining their informed consent and debriefing them later.

Psychologists' values influence their choice of research topics, their theories and

observations, their labels for behavior, and their professional advice.

Responsibility for considering reducing the number of animals (Reduce).

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