Journal of Current Chemical and Pharmaceutical Sciences
ISSN: 2277-2871

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Pharmaceutical Development

 Pharmaceutical development is intended to design a quality drug and a manufacturing process capable of producing the product efficiently with its intended output. A pharmaceutical product should be developed to meet the needs of the patients. The expertise and information gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the design space, requirements, and manufacturing controls developed. A more structured development approach (also known as quality by design) may include, for example, the inclusion of prior experience, the results of studies using experiment design, the use of quality risk management and the use of knowledge management across the product's lifecycle. The process of pharmaceutical development begins by measuring the properties of the drug substance, and by identifying the critical quality attributes of the required drug product. This process will include checking the drug's absorption and stability profile, and the most suitable route of administration (oral, parenteral, or local). It is of great importance that the properties of the drug substance are matched to the formulation needed to meet the clinical and marketing profile. The properties of the drug substance will significantly limit the formulations that can be used, and require comprehensive research to fulfil the profile required. If clinical research is successful, pharmaceutical production of a commercial product is needed by developing a wide understanding of the properties of the drug substance and drug product and its manufacturing behaviour. The end product has to be safe, reliable and efficient.  

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Citations : 3927

Journal of Current Chemical and Pharmaceutical Sciences received 3927 citations as per Google Scholar report

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