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These are my five tips to get through the day

Plan for the week and not for the day. One thing I have learnt after having kids is that

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

things don’t always go as planned. Some days my son is just clingy for only reasons he knows or he has a sleepless afternoon or I could be tota

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

Examples of combination products may in

lly exhausted after a sleepless night. Prior to having kids, at the end of each day I would cross off the things I finished that day and then m

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

ove the unfinished tasks for the next day. This worked well because I had child free days and I managed to get most the things on my to-do list

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

crossed off (most of the time). But this approach did not work for me after I had my children. At the end of the day when I looked at my to-do

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

Combination pro

list, most of the tasks were still unfinished. This would leave me sad and a bit depressed. And then one day I decided that things would be b

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

etter if I planned for the week and not the day. This way even if I have a couple of bad days, its okay because I will have a couple of good da

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 in the week when I can finish the tasks. Of course there are some activities (like clearing off my inbox) that have to be done daily.

Hav

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

e ‘child only’ time. Every day in the mornings I spend a few hours with my son. My son and I go out in the mornings to finish all our outdo

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

or errands. This way while I finish my errands, my son enjoys his time out. When we come home, he is usually exhausted and hungry. I feed him a

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

nd then he has a nap for an hour or two. This is when I get into my business work. There are times when I have a deadline looming on one hand a

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

Following aspects would a

nd on the other he is getting bored and is a bit cranky. Though its tempting to attend to my deadline project first, I have learnt that its bet

dd to the challenges in developing combination products:

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

ter to put him first, spend time with him, get him a bit tired and then when he is asleep I can start my work.

There is no better time than

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

‘now’. For household chores don’t accumulate and do them all in one go. I find this takes up more time. As I am walking into a room if I f

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

nd toys lying everywhere, I just spend a couple of minutes and get the toys into the toy box. If I have some spare time I might just chop the v

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

eggies and keep them ready for dinner so that when its time to cook dinner at least I have some of the ingredients chopped up.

Menu Plannin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g saves time. I normally plan my weekly menu on the day that I go grocery shopping. I actually hate planning the menu one week in advance.

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

But if I don’t do it everyday its like what do I do for lunch, afternoon tea and dinner? Planning in advance clears up a lot of your time.

.

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

Take care of yourself. If you are not well nothing gets done and the whole house will be in chaos. It’s important that you take care of you

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

Companies that provide selfless information through particip

r health. I have vitamins everyday. I try to exercise at least 3 times in a week. Have at least one cup of a coffee or tea before it turns cold

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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