Posted by admin on Apr 30, 2016 in |
Although plenty of information relating to drug utilization among adults is available, the literature pertaining to children is scarce. The majority of drugs prescribed have not been tested in children and safety and efficacy of children’s medicines are frequently supported by low quality of evidence. This is explained by the lack of clinical research in this population, caused by ethical, scientific and technical issues, besides commercial priorities. Therefore, most of the therapies prescribed to children are on an off-label or unlicensed basis. The off-label and unlicensed use of medicines is widespread and variable depending on the level of health care available, speciality concerned and patient characteristics. In the recent years, various laws and guidelines from the competent authorities have come up regulating the drug use and clinical research among children. This article reviews various pros and cons of the off-label use of medicines in children including various types, incidence rates, reasons, risks, consequences, management modalities, national and international guidelines related to the...
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Posted by admin on Apr 30, 2016 in |
The post approval changes are the changes made to biological products that have received an approval and to provide the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the products. After the approval of NDA or ANDA, the applicant may make post approval changes, provided the changes are reported to the FDA under the appropriate categories. Section 506 A of the Federal Food, Drugs and Cosmetics act and 21 CFR 314.70 provide for three reporting categories of the post approval changes namely: major change, moderate change and minor change. There are many reasons for making changes to pharmaceutical products after the original regulatory approval is obtained. Company change control procedures should detail how changes are evaluated and implemented as well as how the change impacts stability and what data will be needed to support the change. The regulatory group will...
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Posted by admin on Apr 30, 2016 in |
Nanoparticles have attracted the interest of many research groups and had been utilized in an increasing number of fields during the last decades. Various methods can be used to produce nanoparticles such as ionic gelation, solvent evaporation, microemulsion, emulsion cross linking and precipitation. This review covers the general description, preparation and the detailed description of crucial parameters involved in techniques designed to obtain the desired properties of...
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Posted by admin on Apr 30, 2016 in |
Genome engineering field is a new revolution in biological research and to this new field several restriction endonucleases are available. Out of all these, based on easier construction, sensitivity and specificity Clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated (Cas) preferred by scientists for research and industrial purposes. However, off-target DNA cleavage causes limitation to researchers who are interested in using engineered nucleases in gene or cell therapy. To overcome this issue, there is a need to design gRNAs which will produce CRISPR/Cas products with high specificity. Till writing this manuscript, there is no compile details available on such bioinformatics tools. Therefore, in this review we are trying to provide platform of information for research scientist who are working on CRSPR-Cas technology so that they can use these online and offline tools to prevent CRISPR/Cas off-targeting in research and industrial field depending on the type of...
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Posted by admin on Mar 31, 2016 in |
Conventional chemotherapy drugs show lack of specificity, including reduced activity on cancer treatment with higher toxicity to normal cells and develop resistance after prolonged period of administration. Recently, to nullify all adverse effects of cancer chemotherapy nanometer sized carriers came into role for total cure. The advanced research community is focused on smart drug delivery system owing to their vivid biomedical and pharmaceutical applications. This article will provide an in-depth discussion on development of smart nanosized carriers for tumors targeting and highlight important role of QDs in highly challenging area of...
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