Summary - Relationships

Faith is one of the biggest assets. Most of us have faith in God. That means that we always beli

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

eve that god will help us whenever we call on him. That God will be always support us. That god

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

Examples of combination products may in

loves us and wants us to grow. God will never leave us alone. This faith is the greatest strengt

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

hs of many of us. What about your partner? Do you have this kind of faith in him/her?

Many will

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

answer that I have that faith in my partner. That is good. At least they have that faith. Many o

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

Combination pro

f you will not be sure about the answer and quite many know that they cannot have faith in their

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

partner. Does your partner have faith in you? Why don't you ask this question and find out the

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

answer? Please ask him/her - Darling, suppose I have someone else in my life for a short time an

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

then come to you and confess will our relations remain the same? Will you forgive me and forget

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

what I did and accept me? Will we be together as we are today? The answer may differ from perso

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

n to person, but you will rarely find a partner who accepts this.

As you broke his/her faith, h

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

Following aspects would a

ow can you expect that their faith will remain intact? That you can expect them to support you a

dd to the challenges in developing combination products:

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

ter you betray them? That sounds difficult. Faith does not work that simply. Faith works on comm

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

itment. If you are committed to your partner and if your partner is a reliable person of integri

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

ty, you may have faith in him/her to a certain extent. To say that my partner will always be wit

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

h me under all circumstances is difficult to say. Only few are lucky to have such partners.

Wha

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

Professional from academic institutions, pharmaceutical industries, health care indust

should we do? Draw an agreement verbally. Commit yourself fully and ask your partner to have fa

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

ith in you always. Ask him/her to commit that you can have the same faith in them. Give proofs f

.

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

rom time to time and you will win unshakeable faith of your partner. Once you have that faith, y

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

Companies that provide selfless information through particip

ou will feel a great sense of relief because you are sure that your partner will never leave 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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Summary - Do You Have Faith In Your Partner?

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