Advice Pool - Health and Fitness

The experienced eyes of the doctor commonly diagnose genital herpes. Most of the doctors recognize the disease with clinical

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

examination. To confirm the presence different tests are done. Many times the test reports indicate absence of herpes. They n

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

eed to be repeated after some days. All the testing facility may not be available everywhere. You need to discuss with your d

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

octor about the reliability of the test and identification of HSV1 or HSV2. The test reports may be misleading if sample is w

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

thdrawn from old crusted sores. The common tests that are done to find out the presence of herpes are as below.

Viral Cultur

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e-

The common test to confirm the presence of herpes is culture test. In culture test, a small sample of fluid or cells is t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

aken from the suspected sore with a swab. This sample is sent for testing. Many times, the results may be negative but you ma

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

y be having genital herpes. This test is therefore repeated after some time. The test reports of rapid viral test can take 2

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

o 3 days while that of standard culture may take up to two weeks.

Herpes virus antigen detection test- In this test, cells t

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

hat are taken from the sore are viewed under a microscope,. The presence of herpes antigens confirms the presence of herpes i

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nfection. The results o9f this tests are reported in a day.

PCR- this test is done on cells or sores. In this test the DNA o

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

f herpes virus is detected. This test can identify between the two types of Viruses- HSV1 and HSV2. PCR results are reported

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ithin three days.

Blood test-

In blood test, blood is drawn either by a needle or with a pinprick. This blood is tested for

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

the presence of herpes virus. Some tests can identify between HSV1 and HSV2. A blood test can only tell you about the presen

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ce of virus in your body. It cannot tell you if you have an active breakout.

Commonly blood is tested for the presence of an

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ti bodies of herpes virus. Your doctor will inform you about the reliability of the blood test he/she has performed, because

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

any varieties of blood test options are available. Antibody test results are reported within two days.

This article is only

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

for informative purposes. This article is not intended to be a medical advise and it is not a substitute for professional med

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ical advice. Please consult your doctor for your medical concerns. Please follow any tip given in this article only after con

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

sulting your doctor. The author is not liable for any outcome or damage resulting from information obtained from this article

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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