what is difference between drug products and drug substance?
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Answer / meghana
Drug substance is a pure material which exerts a pharmacological action while Drug product is a finished end product which may contain one or more drug substances in combination with excipients meant for use by humans and animals
| Is This Answer Correct ? | 164 Yes | 6 No |
Answer / sameer jagtap
drug product is ready to use for human body i.e
tablet,capsule,injection in short formulation finished
product on the other hand drug substance is raw
material(Active Pharma Ingradients) used for the preparation
of drug products.
Drug substances are not ready to use by human body.
| Is This Answer Correct ? | 79 Yes | 10 No |
Answer / md. zafor iqbal
Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
Drug substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient.
| Is This Answer Correct ? | 18 Yes | 4 No |
Answer / aditya
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc.,
which has not previously been registered in a region or Member State, and which
contains a drug ingredient generally, but not necessarily, in association with
excipients. is drug product
The designated therapeutic moiety, which has not previously been registered in a
region or Member State (also referred to as a new molecular entity or new chemical
entity). It may be a complex, simple ester, or salt of a previously approved drug
substance.
| Is This Answer Correct ? | 5 Yes | 16 No |
Answer / lucid
A substance is a chemical matter which when taken into the body interacts with a living system through physical or chemical processes to cause beneficial or harmful effects. While
A drug is any chemical substance that causes a therapeutic effect in a living tissue or in a human body.
| Is This Answer Correct ? | 4 Yes | 18 No |
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