Advice Pool - Self Improvement

"As human beings, our greatness lies not so much in being able to remake the world ... as in being able to remake ourselves."

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

Mahatma Gandhi

Mahatma Gandhi was one of the most influential figures of the 20th Century. He pioneered the concept of re

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

Examples of combination products may in

istance through civil disobedience which led to the downfall of British rule in India and the birth of the modern nation.

He

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

is recognised as the father of the nation and his birthday is celebrated every year as the festival of Gandhi Jayanti. Gandhi

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

s civil protest movement has inspired movements for civil rights and freedom across the world.

This success quote from Gandh

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

Combination pro

is one of many pieces of wisdom from the great man. It is about his core philosophy that enabled him to make the remarkable

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

achievements that he did.

Gandhi successfully organised a mass movement that bought down oppressive British rule. The Britis

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

attempted to rule by force, imposing their will on the Indian people. Gandhi took the opposite stance and led by consent. Hi

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

inner strength meant that people willing followed him.

Gandhi was recognised by the Indian people as Mahatma (great soul) o

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

Bapu (father). He was able to lead the highly fractious political parties in their pursuit of independence through the stren

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

th of his personality.

A cornerstone of Gandhi’s philosophy was a deep commitment to constantly searching for universal trut

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

Following aspects would a

h. He was also driven by compassion for the suffering of his fellow man, including his fellow countrymen. He spent his whole

dd to the challenges in developing combination products:

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

ife constantly working on improving himself to bring himself closer to that universal truth.

Gandhi led a life of self sacri

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

ice and rigorous self discipline which gave him the inner strength to stand up for his principles in the face of all odds. He

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

was even willing to accept rejection from the whole world to retain his integrity towards his ideals.

Gandhi’s belief system

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

included the principles of human equality, non-violence, strong divine guidance and the need to live a good life. His belief

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

Professional from academic institutions, pharmaceutical industries, health care indust

system give him the strength to organise the civil disobedience campaign in India.

Reflect on this success quote from Mahatm

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

Gandhi. How are you leading your life. Are you trying to achieve success or even greatness through forcing the world to your

.

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

point of view? Do you need to work on yourself to increase your ability to attract people towards you?

Do you want to find m

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

Companies that provide selfless information through particip

re success quotes

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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