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Historically—this is an extremely shortened version of this account— the Lenten season tell us about the time when Jesus, the Christ went to the wilderness to ref

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

lect and meditate. Among other things, he spent 6 weeks, about 40 days, without food and shelter. Just meditating.

Nowadays, if you are a Christian, you know tha

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

Examples of combination products may in

t the Lent season starts after Carnival, or Mardi Gras, and lasts 40 days, culminating with the celebration of Easter. This is a good piece of information even if

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

you are not Christian.

For those who live in the Northern Hemisphere, this is a time when spring is coming, and with it, the sense of renewal or rebirth of natu

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

e. For those who live in the Southern Hemisphere, it is a time when autumn arrives and with it, the quieting of the Earth and the preparation for the darkness of

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

Combination pro

winter. In both cases, nature invites reflection.

Now you may ask: “What do I care about Lent if I am not a Christian? Well, I say that no matter what religion y

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

ou belong to, if any, seeing that nature is also inviting you to become more aware of the seasonal changes, Lent may be the best excuse for you to go into your ca

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

e for a little while and, as others have done before you, to reflect and meditate on your life.

What can you do to take advantage of such a great time for the re

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

newal of your soul as well as the renewal of your body and your life?

Here are some suggestions:

1. Take time off. Go for walks, take hot baths, go for bike rid

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

es, or skiing, etc; preferably alone.

2. Quiet down. Be silent. Turn off the radio. Avoid phone calls.

3. Refrain from watching TV, especially the news. Remembe

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

that there is always someone who will let you know what horrible tragedies are hitting the globe. You will not feel deprived of information.

4. Slow down: deleg

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

Following aspects would a

ate what you can. Put off for tomorrow as much as you can. The world will not end because of that.

5. Eat wholesome, nutritious food. Let go of sugar and junk. E

dd to the challenges in developing combination products:

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

at organic foods and take your supplements.

6. Let go of grudges, resentment, judgment, unkindness. When your mind starts rampaging on someone, immediately turn

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

your thoughts around and send the person to the light. That includes you.

7. Avoid conflicts. Stay away from arguments. Use your manners. Be nice to people. Smil

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

.

8. Pray. Ninety percent of the planet’s population believes in a higher power. No need to ask for anything. God already knows what you need. Just be thankful f

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 your many blessings.

9. Focus on what you want and it will expand and manifest to you. Dream. Dream big.

10. Appreciate everything around you. Bless everyone

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

Professional from academic institutions, pharmaceutical industries, health care indust

you encounter.

11. Care for those who cannot care for themselves. This includes older people, children, and animals.

12. Be gentle with yourself. Use natural p

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

oducts for your body. Move slowly. Practice some Yoga or Tai Chi. Take deep breaths.

13. Cleanse your body. Drink herbal and medicinal teas.

14. Do your journal

.

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. Use mine if you don’t like to write that much.

15. Meditate on your life. Where are you? Where do you want to go?

There. I hope you will pick up on some su

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

Companies that provide selfless information through particip

ggestions and practice them for these 40 days. Come Easter, you will realize how much better you feel and how much you have improved the lives of those around you

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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