Others - Writing and Speaking

I’ve just come back to work after nine glorious, sun-drenched days at home. This year, vacation was the week of July 4th. We stayed home instead of dashing off to a cottage on a lake. A

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

side from saving a few thousand bucks, I had plans! Amazing plans! Projects galore, and the gumption to tackle every one of them!

I planned to weed every garden on the grounds. There w

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

Examples of combination products may in

uld be no stragglers left standing when I was through! I would relocate the strawberry and raspberry beds to new locations. That, in itself, would be no small feat, since they are massiv

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

e. Massive, and loaded with weeds, I might add. I would rototill a whole new border garden by the roadside and move the choked peonies and sundrops to a new home. It would be splendid!

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

Superb! Riotous with color!

And, best of all, I would completely scour my proofs for Upstaged, the second book in the LeGarde Mystery Series. Due “any day now,” I’d been promised that t

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

Combination pro

ey’d arrive just in time for my carefully planned hiatus. When finished with Upstaged, I’d work on Counterpoint, the ninth book, and write until my fingers cramped or I became a mummified

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

author, glued to the laptop with a glazed expression of delight on my ugly mug. I was psyched! I was ready! I was bursting with energy!

On top of the lofty goals for garden and books,

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

I planned to spend every possible second with my grandsons. Julian, two and a half, is a whirling dervish who actually helps me in the gardens and keeps up a constant, delightful chatter

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

that offers true companionship. He attacks the weeds with relish, and has begun to recognize the difference between the bean plants and the pigweed. Gordon, one and a half, toddles aroun

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

happily, playing with the dirt and water and the sandbox until he is covered in mud. Both boys beg for rides on the lawn tractor, and we spend many an hour riding around the grounds, duc

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

ing beneath low hanging branches and plucking ripe gooseberries and blueberries from the bushes that we pass. The boys provide superb inspiration for my characters in the LeGarde mysterie

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

Following aspects would a

s. Gus, the protagonist, is blessed with three grandchildren. I soak up as much detail as possible when I’m with those little ones. Aside from the soul-quenching love that I receive, the

dd to the challenges in developing combination products:

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

keep me hopping.

All right. Back to the plan. How did it turn out? What vacation ever turns out as planned? Who’s ever accomplished all of the things on their long “To Do” list?

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

The gardens were finally weeded to completion. They’ll stay that way for a few weeks. I never did move the major beds or start the roadside flower show. We picked and cooked gourmet fe

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

sts with cukes, zucchini, beans, beets, kale, peas, strawberries, blueberries, raspberries, and more. I spent hours with my little buddies, lolling in the sun, floating in the pool, and d

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

gging in the dirt. Julian learned to jump in the water and go under! Gordon munched on Blue Lake beans and added to his vocabulary. I enjoyed a successful book signing at Borders. And

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

Professional from academic institutions, pharmaceutical industries, health care indust

I wrote like the wind.

Upstaged didn’t arrive – matter of fact, it’s now due tomorrow, the day I return to work! But I polished up Mazurka, which is due to my new publisher soon, anyway.

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

It’s ready to go and should be out in November.

I’ll be back to work in the morning. Glad to see my friends, but cringing at the thought of losing this amazing sense of freedom. As I’v

.

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

e been sitting here writing this, it struck me. THIS is what I want to do when I grow up! Forget about that engineering stuff, I want to stay home! To spend time outside! To write! To

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

Companies that provide selfless information through particip

cook! To love my grandbabies! To create roller coaster stories, ripe with life and endearing characters, to be passionate and alive and free!

Sigh. When I grow up, I want to be… retired

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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Since there are so many franchise opportunities out there it can be difficult to evaluate them all and decide on the best one for you, especially if you are over the age of 50. Fortunately, there are plenty of franchise opportunities for the 50 plus entrepreneur. Perhaps this brief overview will give you some new business ideas that you could research and pursue!

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Recent changes to the UK's quarantine laws mean that it is now possible for you to obtain a pet passport (under the government's 'passport for pets' scheme) and take your family pet away with you on holiday.

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