BME- 2205,

BIOMEDIC
AL ETHICS
AND
SAFETY
Anika Anjum
Lecturer, BME, JUST.

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09/02/2023
FDA Guidelines for Drug
Development and Approval

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DRUG PRODUCT
 A drug product is the finished dosage form (e.g. capsule, tablet, injectable etc) that contains

API (Active Pharmaceutical Ingredients), general in association with other excepient, or

inert ingredients.

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Toxicology is a field of science that helps us understand the harmful effects that chemicals,
substances, or situations, can have on people, animals, and the environment

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Bioavailability: the
proportion of a drug or
other substance which
enters the circulation
when introduced into the
body and so is able to
have an active effect.

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The therapeutic index (TI; also referred to
as therapeutic ratio) is a quantitative
measurement of the relative safety of a drug. It
is a comparison of the amount of a therapeutic
agent that causes the therapeutic effect to the
amount that causes toxicity.

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