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Nothing is harder than facing teenagers and having to say no to a variety of things. As parents, however, we all know we have to. We som

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

etimes have to say no to going out with friends and occasional trips. This can lead to problems with our teenagers and the feelings of g

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

Examples of combination products may in

ilt that it is our fault for saying no. The important thing still remains that, even though they are teenagers, they still need our guid

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

ance. If you are looking for some ways to be able to say no and not have the guilt, here are a few ways.

Define boundaries and/or ne

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

otiate them

If you are dealing with older teenagers, there is a great way to be able to say no and not feel the guilt. Sit down wi

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

Combination pro

h your teenager and define the rules of the house and any outings. Be willing to listen and hear your teenager’s side of the story and t

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

heir arguments. They are old enough at this point to think things through and be able to present you with justified and legitimate reaso

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

s for what they are asking. Negotiate the rules. Then, when something comes up that requires you to say no, you don’t need to worry abou

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

the guilt because the boundaries were defined by both parties and agreed to each of the rules.

Don’t say no without a reason

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

Teenagers are not your little children anymore. They are almost adults and can reason like them. Saying no with the reason of 'because I

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

said so' will no longer work and will most likely lead to greater problems. Be willing to give your teenagers justified reasons why you

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

Following aspects would a

re saying no. Also be willing to consider changing that no to yes if they can provide decisive and true arguments to counter act your re

dd to the challenges in developing combination products:

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

asons. It’s good preparation for when they finally become adults.

Be consistent

If you say no for something once and nothing h

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

s changed, make sure to say no every time. Or say yes every time. Being consistent is one of the key factors in parenting that remains,

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

o matter how young or old your child is. Remember to stick to the rules that you’ve made. You can’t expect your teenager to follow them

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

if you don’t or aren’t willing to consistently back them up. The best way to feel guilty about saying no is when you’ve said yes in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ast to the exact same thing.

Parenting is not an easy job but it can be immensely pleasing. Each stage in our children’s development br

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

ngs new challenges. Remember these key points and you won’t have to worry about feeling guilty the next time you have to say no 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

teen. Define the rules or boundaries, don’t say no without a reason and be willing to discuss the reason, and be consistent. Keeping the

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

Companies that provide selfless information through particip

e points in mind and putting them into practice is a good way to form a peaceful co-existence with your child during their teenage years

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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