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Pharmaceutical Technology, Manufacturing, Quality, Business Transformation & Continuous Improvement Blog

Changes in Drug Application Process to Health Canada!

4/28/2017

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changes in drug application process to health canada


Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. The agency also notes that sponsors can request an exemption from the requirement for individual products, but says it expects companies to provide their "rationale for the exemption as well as an intended plan for converting to eCTD format."
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Shruti Bhat, PhD (Tech.), MBA, Certified Lean Six Sigma Black Belt is Continuous Improvement mastermind for Pharmaceuticals & Medical Devices Industry. She is often called "Profitability expert' More about Shruti at http://www.shrutibhat.com/

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Future of influenza virus seems glum ! Nano technology incredibly employed in anti- viral drug delivery system.

2/17/2015

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Bad news for influenza virus - Nano tech can destroy it now.

As we know currently marketed anti-influenza drugs, including Tamiflu have been reported to only suppress influenza virus and not destroy it.

However, combined play of Pharmaceutical science and Nano technology have allowed development of unique delivery system that contains a peptide that sits on the virus, while the bio-degradable Nano- vesicle attracts this conjugated virus, engulfs it, thereby destroying it completely.

Similar work is also on-going towards treatment options for dengue.

Posted by Technology Watch Cell,
Innoworks Inc. Canada
www.Innoworks.ca
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FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients.

7/7/2010

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Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data. 

The U.S. Food and Drug Administration yesterday announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).  

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times. AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading ... 

Read more at http://www.pharm-education.com/2010/07/fda-approves-first-implantable.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

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Nanotechnology in Pharmaceutical Research- Magnetic fields drive Paclitaxel -loaded nanoparticles to reduce blood vessel blockages.

4/28/2010

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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. 

Scientists and engineers have used uniform magnetic fields to drive iron-bearing nanoparticles to metal stents in injured blood vessels, where the particles deliver a drug payload that successfully prevents blockages in those vessels.  

In this animal study, the novel technique achieved better results at a lower dose than conventional non-magnetic stent therapy.

Conducted in cell cultures and rats, the research is the latest in a series of studies at The Children's Hospital of Philadelphia demonstrating the feasibility of magnetically guided nanoparticles as a new delivery platform for a variety of possible therapeutic cargos: DNA, cells and drugs. The findings may set the stage for a new medical tool, called vascular magnetic intervention....


More at http://www.pharm-education.com/2010/04/nanotechnology-in-pharmaceutical.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10


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Nanotechnology- A new tool in pharmaceutical research?

4/26/2010

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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Who's regulating nanotechnology? 

Nanotechnology and its applications are so small that it can be hard to get your head around, but there are more than 1,000 products with nanomaterials already on the market, so we'd better get a handle on this quick. 

Nanoscale science and technology manipulate matter at the level of 1-300 nanometers (or billionths of a meter) and claim a seemingly amazing array of applications for medicine, technology, energy and food. Pulitzer Prize-winning reporter Andrew Sheider's recent investigative series ...

Nanopatch tipped to replace syringe :  

Researchers have used nanotechnology to discover a far more effective and less painful vaccination technique than the syringe. 

University of Queensland Professor Mark Kendall's bio engineering and nanotechnology team have developed the Nanopatch - which uses 100 times less vaccine than a syringe and is smaller than a postal stamp. The patch is tipped to revolutionise vaccination programs in both industrialised and developing nations, which must overcome issues with vaccine shortages and distribution. Prof Kendall said ... 

More at http://www.pharm-education.com/2010/04/nanotechnology-new-tool-in.html 

References-
http://news.smh.com.au/breaking-news-national/nanopatch-tipped-to-replace-syringe-20100424-tjsl.html

http://www.tcdailyplanet.net/blog/iatp/whos-regulating-nanotechnology

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel :
Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author? 

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    Shruti Baht, pharmaceutical consultant, continuous improvement expert
    Dr. Shruti Bhat

    Pharmaceutical Manufacturing,  Continuous Improvement and Business Transformation Consultant


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