E-Articles - Health and Fitness

Testosterone is a major player in the complex mielu of hormones (cellular messengers) that direct our bodies to function. In men who are over the age of 40, there is a

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

significant drop in this level of this hormone. Until recently it was considered taboo to replace this important hormone. But today forward thinking anti-aging speci

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

Examples of combination products may in

alists realize what scientific studies over the past decade have taught us.

As with women who have gone through the change of life, replacement of their sexual hormone

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

(estrogen, progesterone and testosterone) enact major health benefits such as osteoporosis prevention, heart disease prevention and increases in cognitive function. L

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

ikewise for older male subjects the benefits of the addition of testosterone under careful physician management is a crucial aspect of maintaining good health. I wish

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

Combination pro

n this article to dispel some misconceptions about Testosterone Replacement Therapy and provide a list to readers of the benefits of this simple and safe treatment.

Fi

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

rst of all there is overwhelming evidence in the scientific literature that testosterone does not cause prostate cancer. In actuality it is the unbalanced estrogen exc

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

ess in man that is implicated in prostate cancer.

The caveat here is that once there is prostate cancer, testosterone which is an anabolic (building) hormone can promo

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

e cancer growth, but contrary to the popular belief, even within the medical field, it does not cause cancer. With advancing age Testosterone levels drop while estroge

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

n levels rise and compete for binding sites on the prostate gland as well as other cells in the body causing a hormonal havoc.

Such problems as an increase in adipose

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

issue with midsection obesity, a decrease in muscle mass, generalized hormonal imbalances (growth hormone, estrogen, thyroid), depression, increased cholesterol and lip

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

Following aspects would a

id dysfunction, glucose and insulin imbalance, decreased coronary artery elasticity, elevated blood pressure and loss of a feeling of well being result from low testost

dd to the challenges in developing combination products:

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

erone levels. Supplementing Testosterone in the appropriate candidates reverses these unwanted outcomes, but it is not as simple as taking a pill. There are enzymes i

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

our body that can change exogenous testosterone into other undesirable hormones such as Estrodiol and DHT. Therefore, a physician that understands the balancing act a

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

nd has the ability to monitor these other hormones is best to treat such a disorder.

Along with the correct replacement modality (cream, gel or patch) there are other

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

onsiderations which halt the trend of testosterone conversion and these are usually supplemented along with testosterone. Such supplements are Saw palmetto, Zinc and N

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

Professional from academic institutions, pharmaceutical industries, health care indust

ettle extract to name a few. In a recent study of the Androderm patch after a 12-month period a depression score dropped by nearly one half with testosterone replaceme

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

nt alone. Again men with complaints of fatigue receiving testosterone in one study had symptoms of fatigue drop for 79% to 10%. A Medline medical literature search re

.

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

eals many more positive outcomes of testosterone replacement. For those interested in finding out more about their bodies, there is a non-invasive home testing kit ava

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

Companies that provide selfless information through particip

ilable at the Saleeby Longevity Institute which allows men to evaluate the levels of testosterone in circulation.

Andropause the male menopause
by J.P. Saleeby, M

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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