Product Development
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In drug product development we want to clarify
- What is the best dosage form for therapy?
- How the absorption site and duration of the drug effect can be optimised?
- How the drug quality can be assured?
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The aim of drug product development is to develop a drug product that releases the drug substance at a predetermined rate at the right location in the body. Different excipients and technologies are used to control the drug release from the product. The route of administration and dosage form are selected based on the treatment needs (e.g. tablet, injection, gel, inhalator etc.).
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During the clinical Phases I-III the requirements for the drug product will be specified and usually the drug product used in the Phase III resembles the final, commercial product.
The manufacturing processes of the drug substance and product will also be developed to be efficient and of high quality. All drug products used in clinical studies, and later in the market, should meet the predetermined requirements.
Therefore, development of the quality control methods for drug substance and drug product is one essential part of this Phase. |
Updated
Dec 17th 2010