Friday, April 23, 2010

AspenBio Pharma developed a Medical device diagnosing appendicitis

Medical devicefor diagnosing appendicitis.
AspenBio Pharma a leading biotechnology company has come up with its patented devise which they claim that is usefull in diagnosing appendicitis .

The AspenBio Pharma’s test is a patented assay method which is capable of detects a marker and protein compounds in the blood of patient with a appendicitis the marker antigens and protein compounds are produced by process of inflammation in appendicitis, after the FDA approval for the device, it will the first of its kind diagnostic tool available in the world for appendicitis and it is said that the device will be useful in diagnosing , evaluating, safe, economical and faster diagnostic test appendicitis.
The AspenBio Pharma is in the process of finalizing the out come results of their clinical trial for this device and for submission of 510(k) ( What is 510(k) clearance )
Brand name for this devise is AppyScore and is estimated to fetch about $1 billion globally every year.

This tequnique (AppyScore ) will be cheaper compared to the regular techniques used like CT scans and are less time consuming than CT scans.
AppyScore consists of , a cassette and reader instrument which can give results with more accuracy and rapidly than the ELISA format. AppyScore is said to have many advantages over an ELISA-based test. It can provide results in 15 minutes, it has a built-in electronic interface which can be used to load the test results in the hospital’s computerized Laboratory System.

What is appendicitis

There is a cecum a structure of colon which looks like a pouch. And there tube like blind ended structure avg. 10 cm in length this structure is called appendix its location is near the junction of the small intestine and the large intestine.

Appendix is belived to have immune function as it consist of lymphoid cells , they fight incoming infection in GIT, it also helps in maintaining the beneficial intestinal bacterial floora .

The inflammatory condition of Appendix is known as appendicitis , it result in severe acute abdominal pain , and if left untreated may become life threatening due to peritonitis and shock.

The treatment so for appendicitis is surgical removal of inflamed Appendix ,and early diagnosis is important part in treatment of appendicitis.

Appendicitis becomes critical in case when it ruptures and spreads infection over gastrointestinal organs and body parts , in such cases recovery is slow and may prove fatal , hence many times in emergences preferred treatment for appendicitis is appendectomy, on time diagnosis is also equaly important for appendectomy surgery

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs


Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

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