Monthly Archives: February 2015

The Meaning Of Rare Disease Day: Sam Berns, Mindfulness, And Rainbows

The Meaning Of Rare Disease Day: Sam Berns, Mindfulness, And Rainbows.

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ANTHONY CRASTO VENTURES INTO CHINA…..MY KAIXIN BLOG 开心网 ON MEDICINAL CHEMISTRY

ANTHONY CRASTO VENTURES INTO CHINA…..MY KAIXIN BLOG 开心网 ON MEDICINAL CHEMISTRY.

USP Chapter Visual Inspection of Injections published

USP Chapter Visual Inspection of Injections published.

USP Chapter Visual Inspection of Injections published

DRUG REGULATORY AFFAIRS INTERNATIONAL

The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1) for commenting. Read on.

http://www.gmp-compliance.org/enews_4682_USP-Chapter–1790–Visual-Inspection-of-Injections-published_40007,9087,9200,Z-PEM_n.html

The long-awaited USP Chapter <1790> regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41(1) for commenting.

The new chapter is comprised of the following sub-chapters:
1. Scope
2. Introduction
3. Typical Inspection Process Flow
4. Inspection Life-Cycle
5. Interpretation of Results
6. Inspection Methods and Technologies
7. Qualification and Validation of Inspection Processes
8. Conclusions and Recommendations
9. References

This new informative chapter is applied to the manual, the half-automatic and the fully-automated inspection of parenterals. It mainly aims at controlling particles (>50 µm), but also comprises indications to further defects like cracks in primary containers or poorly fitting stoppers. In Chapter 2 there are also general statements regarding the patient risk due to…

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DRUG APPROVAL PROCESS IN INDIA

DRUG REGULATORY AFFAIRS INTERNATIONAL

click below

  • a review on drug approval process for us, europe and india …

    This article focuses on drug approval process in different countries like USA, Europe and India. Keywords: MAA, USFDA, Drug approval, Clinical trial.

     click below
  • NEW DRUG APPROVAL PROCEDURE IN INDIA …

    http://www.pharmatutor.org/articles/new-drugapprovalprocedureindia

    The new drug approval is of two phase process – the first phase for clinical trials and second phase for marketing authorization of drug. Firstly, non-clinical …

    The regulatory scenario in India is changing very fast and DCGI is coming up with precise guideline on each topic. The documentation for product registration in India has become at par with US FDA and seems to objective of DCGI so that data generated in India is acceptable globally. Ever-changing laws and regulations are driving demand for regulatory affairs professionals to…

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Jeans for Rare Genes – Local News Coverage

hopeforheather

Jeans for Rare Genes – Local News Coverage.

This is what 2 of my virtual contacts are doing to raise awareness for Cowden Syndrome.  Check it out!  I am so proud to say I “know” them!

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New, aggressive form of HIV identified in Cuba

Atasteofcreole's Blog

http://www.medicalnewstoday.com/articles/289477.php

In Cuba, a variant of HIV that is much more aggressive than other known forms of the virus has been documented. Patients infected with this new variant progress to AIDS so rapidly that they may not even know they are infected, with AIDS symptoms occurring within 3 years of infection.
HIV attacking cellHIV anchors itself to proteins on the membranes of cells before it is able to penetrate the cell.

If a person contracts multiple strains of HIVtypically by engaging in unprotected sex with multiple infected partners – then these strains can recombine into a new variant of HIV within the host. The new Cuban variant of HIV is one such recombinant version of the virus.

HIV anchors itself to co-receptors – proteins on the membranes of cells – before the virus is able to penetrate the cell. The first co-receptor that HIV anchors to is known…

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SILODOSIN………For treatment of benign prostatic hypertophy

New Drug Approvals

Silodosin.png

SILODOSIN

Urief, 160970-54-7, Rapaflo, KMD 3213, Silodyx, KAD 3213, KMD-3213
Molecular Formula: C25H32F3N3O4
Molecular Weight: 495.53449 g/mol

Alpha 1A adrenoceptor antagonist

Prostate hyperplasia

Kissei Pharmaceutical Co Ltd  INOVATOR

CAS 160970-54-7

2,3-Dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

160970-64-9 (racemate)
169107-04-4 (diHBr)

Properties: [a]D25 -14.0° (c = 1.01 in methanol).
Optical Rotation: [a]D25 -14.0° (c = 1.01 in methanol)
Therap-Cat: In treatment of benign prostatic hypertophy.
a-Adrenergic Blocker.

In February 2008, the FDA accepted for review an NDA for silodosin for the treatment of dysuria associated with BPH . In October 2008, the FDA approved the drug . In April 2009, Actavis launched silodosin for the treatment of the signs and symptoms of BPH .

Silodosin.pngSILODOSIN

1-(3-hydroxypropyl)-5-[(2R)-2-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethylamino]propyl]-2,3-dihydroindole-7-carboxamide

Kissei Pharmaceutical, Daiichi Sankyo…

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ANTHONY CRASTO VENTURES INTO CHINA…..MY KAIXIN BLOG 开心网 ON MEDICINAL CHEMISTRY

New Drug Approvals

KAIXIN



MY EASTERN VENTURE TO PROPAGATE CHEMISTRY……………http://www.kaixin001.com/home/?_profileuid=159073878

CHINA

MY EASTERN VENTURE TO PROPAGATE CHEMISTRY……………http://www.kaixin001.com/home/?_profileuid=159073878

MY EASTERN VENTURE TO PROPAGATE CHEMISTRY……………http://www.kaixin001.com/home/?_profileuid=159073878

MY EASTERN VENTURE TO PROPAGATE CHEMISTRY……………http://www.kaixin001.com/home/?_profileuid=159073878

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Urddad-Foundation Answers Northern Ireland Consultation on Rare Disease Plan

Urddad-Foundation Answers Northern Ireland Consultation on Rare Disease Plan.

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