Yahoo Web Search

Search results

1. www.sciencedirect.com › science › articleDevelopment of validated stability-indicating assay methods ...

   www.sciencedirect.com › science › article

   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.

   • Author: Monika Bakshi, Saranjit Singh

   • Publish Year: 2002

2. www.researchgate.net › publication › 322287641(PDF) Stability Indicating Analytical Methods (SIAMS)

   www.researchgate.net › publication › 322287641

   Jan 2, 2018 · PDF | On Jan 2, 2018, Nirav Soni published Stability Indicating Analytical Methods (SIAMS) | Find, read and cite all the research you need on ResearchGate.

3. www.pharmatutor.org › articles › review-stabilityREVIEW ON STABILITY INDICATING ASSAY METHODS (SIAMS)

   www.pharmatutor.org › articles › review-stability

   • Cached

   Jun 15, 2014 · The main contemporary goal of stability indicating methods (SIMs) is to provide information about condition for stress testing so as to establish the stability of drug substances and product. This paper reviews the regulatory aspects for development of stability indicating methods.

   • Author: Salma Quadri, Lalit Sonwane, Bhagwat Poul, Sharada Kamshette

   • Publish Year: 2014

4. ijppr.humanjournals.com › wp-content › uploadsReview on Strategies and Analytical Perspectives of Stability ...

   ijppr.humanjournals.com › wp-content › uploads

   Dec 30, 2019 · Stability indicating analytical method (SIAM) is a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from potential interferences like degradation products,

5. journals.sagepub.com › doi › fullObservations in Qualitative Inquiry: When What You See Is Not ...

   journals.sagepub.com › doi › full

   Nov 28, 2018 · Observation in qualitative research “is one of the oldest and most fundamental research methods approaches. This approach involves collecting data using one’s senses, especially looking and listening in a systematic and meaningful way” (McKechnie, 2008, p. 573).

   • Author: Brigitte Smit, Anthony J. Onwuegbuzie

   • Publish Year: 2018

6. academic.oup.com › jrssig › articleRandomisation: What, Why and How? | Significance | Oxford ...

   academic.oup.com › jrssig › article

   • Cached

   Jul 8, 2010 · One important part of the trial design process is the statement of intention of using randomisation; then we need to establish which method to use, when it will be used, and whether or not it is in fact random.

7. People also ask

   What is a SIAM?

   • As per the FDA regulations, a SIAM is defined as a methodologies for stability studies be stability indicating. There are three components necessary for implement ing a SIAM. 1. Sample generation, 2. Method development, 3. Method va lidation used to develop the SIAM. In simple terms, the goal o f the SIAM is to

   (PDF) Stability Indicating Analytical Methods (SIAMS

   www.researchgate.net/publication/322287641_Stability_Indicating_Analytical_Methods_SIAMS

   See all results for this question

   What is a stability indicating assay (Siam)?

   • 1. Introduction The stability-indicating assay is a method that is employed for the analysis of stability samples in pharmaceutical industry. With the advent of International Conference on Harmonisation (ICH) guidelines, the requirement of establishment of stability-indicating assay method (SIAM) has become more clearly mandated.

   Development of validated stability-indicating assay methods—critical

   www.sciencedirect.com/science/article/pii/S073170850200047X

   See all results for this question

   What are the critical issues related to development of SIAMS?

   • Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of SIAMs for combination products, etc. are also addressed. The applicability of pharmacopoeial methods for the analysis of stability samples is discussed.

   Development of validated stability-indicating assay methods—critical

   www.sciencedirect.com/science/article/pii/S073170850200047X

   See all results for this question

   What is a SIAM synthesis method?

   • STE PS INVOLVED DURING THE DEVELOPMENT OF STABILITY– of its synthesis route. As per the FDA regulations, a SIAM is defined as a methodologies for stability studies be stability indicating. There are three components necessary for implement ing a SIAM. 1. Sample generation, 2. Method development, 3. Method va lidation used to develop the SIAM.

   (PDF) Stability Indicating Analytical Methods (SIAMS

   www.researchgate.net/publication/322287641_Stability_Indicating_Analytical_Methods_SIAMS

   See all results for this question

   How do you determine the accuracy of a SIAM?

   • However, a better method of determining accuracy of a SIAM is by spiking the drug in a mixture of degraded solutions . As far as the precision is concerned, there are no special requirements for stability-indicating methods and the same procedure as advocated for normal assay methods can be applied.

   Development of validated stability-indicating assay methods—critical

   www.sciencedirect.com/science/article/pii/S073170850200047X

   See all results for this question

   Are expert systems used in the development of SIAMS?

   • There are yet not many publications, which have indicated the use of expert systems in the development of SIAMs. However, there are all the chances that they are being used in the development laboratories in the industry.

   Development of validated stability-indicating assay methods—critical

   www.sciencedirect.com/science/article/pii/S073170850200047X

   See all results for this question

8. www.researchgate.net › profile › Nirav-SoniSTABILITY INDICATING ANALYTICAL METHOD (SIAM) - ResearchGate

   www.researchgate.net › profile › Nirav-Soni

   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