Drug substance vs drug product?

Gia Frami asked a question: Drug substance vs drug product?
Asked By: Gia Frami
Date created: Sat, Feb 13, 2021 10:37 PM

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Top best answers to the question «Drug substance vs drug product»

Drug substance vs drug product

  • Difference - Drug substance over Drug product. Drug substance is the active ingredient or Active pharmaceutical ingredient which is used to make the drug product, It is a pure material which exerts pharmacological action on the body. While drug product is the combination of drug substance or two or more more drug substance or excipients.

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Those who are looking for an answer to the question «Drug substance vs drug product?» often ask the following questions:

❔ Drug substance vs drug product definition?

Drug product is the finished product of any drug that is available in the market and is ready to use (this includes it's packaging, see also below). A drug substance, because of multiple factors (sensitivity, stability, etc.) is required to be mixed with other components before being released for use in the market.

❔ What are drug substance and drug product?

A drug substance, because of multiple factors (sensitivity, stability, etc.) is required to be mixed with other components before being released for use in the market. The drug substance together with the added ingredients (= excipients, see next chapter) is known as drug product.

❔ Drug substance and drug product impurities, now what?

Drug substance impurities and drug product impurities are not the same, and are subject to different regulatory requirements. Impurities in drug substances may include starting materials, intermediates, degradation products, etc. In drug substance purity testing, every peak that appears in the chromatogram should be considered a drug substance impurity, unless proven otherwise (eg, solvent peaks). Drug product impurities are defined as, and limited to, degradation products of the drug substance, and reaction products of the drug substance with excipients or the container-closure system. Impurities in the drug substance versus the drug product have important nuances for CMC scientists in terms of specific reporting, identification, and control requirements (see the ICH Q3A (R2)1 and Q3B (R2)2 guidelines). However, for the toxicologist the issue for any impurity that exceeds qualification thresholds is whether sufficient safety information exists, either in completed nonclinical or clinical studies or in the literature, to support continued development or whether the impurity needs to be qualified through the conduct of additional safety studies. Qualification of drug substance and drug product impurities are broadly dependent on the maximum theoretical clinical dose, whereas potential mutagenic impurities must be controlled to levels less than the threshold of toxicological concern based on lifetime exposure. As the program develops, adherence to ICH impurity guidelines is required. Each of these impurity issues are discussed below along with next steps for the toxicologist to address these issues. Sponsors are encouraged to seek qualified experts to help address drug impurity issues.

8 other answers

What are drug substance and drug product? Drug Substance (DS). Drug substance is the pure material that stimulates any pharmacological action. It is the most... Drug Product (DP). Drug product is the finished product of any drug that is available in the market and is ready to use... Excipients…

Biologic drug development consists of two fundamental components: the drug substance (DS) development, which can include the master and working cell bank development, manufacturing process development, and scale-up; and the drug product (DP) development, which includes the filling of the drug substance into the primary container.

substances (e.g., combination drug product, copackaged drug products), information for each drug substance should be presented separately in the application. Information presented separately means ...

Drug Product: A finished dosage form, for example, a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients.

The properties of the drug substance can have a significant effect on the physical and chemical behavior of the drug product. A review of the drug substance physical and chemical properties is per-formed in relation to the excipient characteristics. For example, particle shape of the drug substance can impact the bulk properties of a drug product

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body. Note: Also known as Bulk drug or Drug Substance.

“Conformance to specifications” means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

Small molecule drug substance synthesis is relatively straightforward. For small molecule, drug product is a tablet. For large molecules, a platform of monoclonal technology is used. Drug substance and drug product are stable.

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