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Bipolar disorder is a mental condition that can result in self-mutilation or self-injury. The mere thought is alarming enough but the reality is even more so sin

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

ce this disease can result in suicide.

Since bipolar disorder affects the normal functions of the brain, the patient can perform uncontrollable acts that are of

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

Examples of combination products may in

en considered as unhealthy or even fatal. This is due to the episodes of mania and depression which can lead the patient to react strongly over the simplest of t

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

hings.

Sadness that is caused by disappointments can lead to self-mutilation. A patient that feels guilt over something can cause him or her to blame themselves

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

This often leads to self-punishment that usually comes in the form of self-injury.

Here are some of the most common acts of self-injury related to bipolar diso

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

Combination pro

rder:

Cutting of the Sufferer's Own Skin

This often happens in an episode of severe depression, and there are many reasons why the patient does this. One is th

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

feeling of guilt over a certain event that happened recently or even years back. A breakup with a boyfriend or a girlfriend perhaps, or, if the stress is so int

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

ense then the person's only resort is to divert it into physical pain. Another reason could be for mere pleasure. The episode of mania causes the patient to have

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

excessive energy and forcing it out through self-injury is one way to prove it.

Meanwhile, cutting can also be recognized as a plea for help. Since a patient wi

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

th bipolar disorder is often neglected and left unnoticed, he or she creates a venue where other people can notice him or her, this time through self-injury.

In

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

ppropriate Clothing

Another way to punish one self is by wearing inappropriate clothing for a particular season or climate. One reason why a patient wears thick

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

Following aspects would a

clothing during warm weather is to conceal an object or possible even just themselves, shielding them from the world.

Body Piercing & Tattoos

In some cultures,

dd to the challenges in developing combination products:

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

piercing and tattooing are forms of spiritual conversion. Other people on the other hand consider these acts as self-expression. While these reasons are widely

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

cceptable to many, piercing and tattooing can still be considered as ways of injuring one's self. Sometimes, these self-mutilations (others call it transformatio

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

n) become so addictive and so uncontrollable that they become two entirely different problems.

Reenactment of a Previously Painful Experience

A patient with on

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

or more painful experiences of abuse who is suffering from bipolar disorder can reenact those times if they remain unprocessed or untreated. There are two possi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ble reasons why a person does this: one is to let others know that they are still hurting, and the other is to let him or her experience the pain all over again

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

s a gesture of guilt and unforgiveness.

As was mentioned earlier, these acts are clear manifestations of the intention to harm and can lead to suicide. Recogniz

.

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

ing these acts, therefore, can save the patient's life. If you know someone who is depressed and does this, carefully approach the patient and suggest that he or

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

Companies that provide selfless information through particip

she should consult a psychiatrist. If in case you are the one who is practicing these acts, recognize your condition and seek psychological treatment immediately

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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