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Jun 15, 2002 · In the opinion of the authors, the ‘Selective SIAM’ is that of more importance with respect to new drugs, but for old and established drugs, where significant body of information exists; the use of ‘Specific SIAM’ can do an equally good job during stability sample analysis.
- Monika Bakshi, Saranjit Singh
- 2002
Jan 2, 2018 · Purpose of stability studies is to establish a re-test period applicable to all further batches of the drug substance manufactured under similar circumstances.
Jun 15, 2014 · The main objective of a stability indicating method is to monitor results during stability studies in order to guarantee safety, efficacy and quality. It represents also a powerful tool when investigating out-of-trend (OOT)[2] or out-of-specification (OOS) [3] results in quality control processes.
- Salma Quadri, Lalit Sonwane, Bhagwat Poul, Sharada Kamshette
- 2014
Jun 15, 2002 · This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted.
- Monika Bakshi, Saranjit Singh
- 2002
Dec 30, 2019 · ABSTRACT . The present review. authors discussed stability-indicating HPLC. development but present review focused on different. strategies and conditions of stability-indicating methods. indicating the method is a validated quantitative. analytical procedure to detect the changes in some period of the.
Aug 8, 2019 · Systematic reviews provide a synthesis of evidence for a specific topic of interest, summarising the results of multiple studies to aid in clinical decisions and resource allocation. They remain among the best forms of evidence, and reduce the bias inherent in other methods.
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What are the critical issues related to development of SIAMS?
What is a SIAM?
What is a stability indicating assay (Siam)?
What is a SIAM synthesis method?
Are expert systems used in the development of SIAMS?
What is a 'specific Siam' assay?
Understanding these considerations will enable researchers to effectively present their research question, aim and objective. Implications for practice: To conduct successful studies, researchers should develop clear research questions, aims and objectives. Keywords: novice researchers; nursing research; research aim; research objective ...
