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GLOSSARY (Q-T)

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Q


QA

Abbreviation of Quality Assurance.

System and processes designed to control each step of pharmaceutical manufacturing. The process ensures that the final drug/substance product meets all the required specifications and quality attributes and that all steps in the manufacturing process are done and documented in compliance with Current Good Manufacturing Practices (cGMP).


Quality

An essential or distinctive characteristic, property, or attribute; the suitability of either a drug or substance for its intended use.


Quality by Design (QbD)

Quality by Design or QbD is a science- and risk-based approach to pharmaceutical development and manufacturing. QbD in pharmaceuticals involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality.

In the past few years, the U.S. Food and Drug Administration has implemented the concepts of QbD into its pre-market processes. The focus of this concept is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

The QbD initiative, which originated from the FDA’s Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products and processes that maximizes the product’s efficacy and safety profile while enhancing product manufacturability.


Quality Risk Management

In line with ICH Q9 Quality Risk Management guidelines provide principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.


R


Radiolabeled

Covalently labeled with a radioactive isotope or substance.


Radiolabeled antibodies

Radiolabeled antibodies are conjugated monoclonal antibodies. Conjugated antibodies have been tagged with radioactive particles. Ibritumomab tiuxetan (Zevalin®; Spectrum Pharmaceuticals) is an example of a radio labeled monoclonal antibody. Ibritumomab tiuxetan is an antibody against the CD20 antigen, which is found on lymphocytes called B cells. The antibody delivers radioactivity directly to cancerous B cells and is indicated for the treatment of patients with:

  • Low-grade or follicular B-cell NHL that has relapsed during or after treatment with other anticancer drugs;
  • Newly diagnosed follicular NHL following a response to initial anticancer therapy.

Treatment with this type of antibody is sometimes known as radioimmunotherapy or RIT.


S


Stroma

The matrix or supporting tissue of an organ, as distinguished from its parenchyma, or functional element.

Source: Dorland’s Illustrated Medical Dictionary. 30th Edition. Philadelphia, Pennsylvania: Saunders, an imprint of Elsevier; 2003:1775.


T


Target antigen

A tumor-specific antigen, usually a protein, found on the surface of a tumor cell that is the binding target for the monoclonal antibody component of an ADC.

Source:  [1]Jaracz S, Chen J, Kuznetsova LV, Ojima I. Recent advances in tumor-targeting anticancer drug conjugates. Bioorg Med Chem. 2005;13:5043-5054.

[2] Chari RVJ. Targeted cancer therapy: conferring specificity to cytotoxic drugs. Acc Chem Res. 2008;41:98-107.


Thioether

A sulfur ether; an ether in which sulfur replaces oxygen.

Dorland’s Illustrated Medical Dictionary. 30th Edition. Philadelphia, Pennsylvania: Saunders, an imprint of Elsevier; 2003:1903.


V


 

Vinca alkaloids
Vinca alkaloids are a class of microtubule inhibitor that prevent polymerization of microtubules by blocking the region involved in tubulin dimer attachment. They have also been shown to induce apoptosis in some solid tumors.

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