34 research outputs found

    STABILITY STUDY: REGULATORY REQUIRENMENT

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    Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions

    STABILITY STUDY: REGULATORY REQUIREMENT

    Get PDF
    Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions

    Evidence that breast cancer risk at the 2q35 locus is mediated through IGFBP5 regulation.

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    GWAS have identified a breast cancer susceptibility locus on 2q35. Here we report the fine mapping of this locus using data from 101,943 subjects from 50 case-control studies. We genotype 276 SNPs using the 'iCOGS' genotyping array and impute genotypes for a further 1,284 using 1000 Genomes Project data. All but two, strongly correlated SNPs (rs4442975 G/T and rs6721996 G/A) are excluded as candidate causal variants at odds against >100:1. The best functional candidate, rs4442975, is associated with oestrogen receptor positive (ER+) disease with an odds ratio (OR) in Europeans of 0.85 (95% confidence interval=0.84-0.87; P=1.7 × 10(-43)) per t-allele. This SNP flanks a transcriptional enhancer that physically interacts with the promoter of IGFBP5 (encoding insulin-like growth factor-binding protein 5) and displays allele-specific gene expression, FOXA1 binding and chromatin looping. Evidence suggests that the g-allele confers increased breast cancer susceptibility through relative downregulation of IGFBP5, a gene with known roles in breast cell biology

    Publisher Correction: Evidence that breast cancer risk at the 2q35 locus is mediated through IGFBP5 regulation.

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    This corrects the article DOI: 10.1038/ncomms5999

    Differential expression of antioxidant enzymes under arsenic stress in Enterobacter sp.

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    Arsenic is a major contaminating heavy metal due to its frequent occurrence and toxicity. Out of different remediation approaches, bioremediation using bacteria has been extensively studied. In this study, 29 bacterial isolates were screened for their arsenic tolerance capacity. One of the isolate, MUM2 showed maximum arsenic tolerance (10mM). Antioxidant enzymes were assayed in this isolate under arsenic stress. Although, the CAT activity was found to increase significantly, the SOD activity showed a significant decrease under 9mM arsenic stress. The results obtained suggest a possible role of CAT in combating arsenic stress. Further studies at genetic level would help in developing highly tolerant strains for remediation of arsenic
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