Just Answers - Writing and Speaking

It is no surprise that writers can have struggles between raising children and raising books. Both require the fine art of hard work and concentration.

In order to write,

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

you need concentration. So how do you get it with kids around?

Likewise, how do you put in the hard work of writing with children at your feet?

And more to the point, is

; 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 worth the struggle? Why not just hang up your pencil or your laptop for a few years until you get them into school?

No way, you deserve your writing. There is something

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

about writing that makes a person feel whole. If you're a writer down to the tips of your toes (meaning you do not write for the motivation of money but that sure does hel

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

), then you need to guard this part of yourself to maintain your wholeness for your children. Got it? Yin and yang. Balance. We could all use some of that.

Here are som

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

Combination pro

strategies to balance children and writing.

Office Where Everybody Can See You

Put your office where everybody can see it. It should be in your living room or wherever 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

he social gathering is. Even put it in your rec room. No problem. Children can be trained to stay away from the computer. What they cannot do is supervise themselves whi

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 your off in your office somewhere.

The office needs to be where the children are. No question.

It'll also help to remind you that you have children while you are writin

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

which is a good thing.

Plotting Your Time

If you're used to plotting novels, time to try it with your own life. Get your children into the habit that they get the whole

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

morning of your time but you get the afternoon and they are required to find their own trouble to get into during your time. So if you take them out to a playgroup and they

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

have fun all morning or out on long walks, then in the afternoon whether or not they still take naps, you should be at the helm of your writing career and getting the job do

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

Following aspects would a

e. Set a time limit. Usually a three hour jag of writing should do for an afternoon.

Mix and match. One morning is their morning but one afternoon a week is also their a

dd to the challenges in developing combination products:

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

fternoon.

Explaining

Sometimes with us writers, we don't stick up for ourselves which is hilarious considering no decent character or ours would get pushed around.

Explai

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

to your spouse, significant other that you do need time to do this. It's not just work, it's important to you.

Stand up to your children who are screaming at you to come

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

nd play. "This is my time. I am working and I am on a break from you guys. Go play." They tend to respect this type of parent over one that waffles back and forth betwee

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

n writing and playing. There are boundaries. Kids need those and so does your writing.

What You Could Do

Get up with the birds and write a little extra here and there, p

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

Professional from academic institutions, pharmaceutical industries, health care indust

shing your three hour minimum to a five hour minimum.

Some great writers like Mary Higgins Clarke started this way.

What about Visitors

Same as your spouse. Stand up for

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

yourself. Explain that in the morning when it's the kids time they can come over and not in the afternoon when you should be hard at work.

Divide the time that you spend w

.

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

ith friends, spouse and children and cleave off a good amount a day for your writing.

And if for no other reason, think of your characters. They need to be heard. Are you

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

Companies that provide selfless information through particip

going to bottle up that part of you for the next six to ten years before your kids all get into school? Wow, that could lead to character constipation and nobody wants that

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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