I Suggest - Home and Family

A few days before Christmas, I was sitting at the computer reading email (reading all the posts from the Yahoo group

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

of waiting moms, of course!), and enjoying some Christmas music playing in the living room.

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

Examples of combination products may in
– “Rudolph the Red-Nosed Reindeer” came on – the original, old Gene Autry version. I burst into tears, crying li
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 a baby.

It was like an out of body experience – I felt like I was hovering over the scene watching myself - b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
wling like crazy, typing away at the computer.

“Hmmm….what is going on here?” (I say as I watch
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
myself, analyzing the situation).

Why on earth would “Rudolph the Red-Nosed Reindeer” make me cry u
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
controllably?

Am I being sentimental about my childhood?

Am I homesick for my family in Texas?
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>
Do I still wish I were 5 years old? (well, honestly – sometimes I do!)

Fast forward about 3 hours. My
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
husband and I are enjoying a delicious dinner (which he cooked!), and it happens again. This time the song is sung b
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
y a precious child with a bit of a lisp - “Happy Birthday Jesus”. I burst into tears and my poor husband looks stunn
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
d!

Doug: “What’s the matter?” “What’s wrong?”

Edi: “Nothing – really, I’m fine, honey. I’m n
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
t sad. Nothing is wrong. I’m happy. I’m just crying.”

Within a minute or two, I AM fine - as if no
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
hing at all happened. My husband sits there, flabbergasted, wondering if aliens have abducted his wife and replac
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ed her with a replacement model which has some wiring defects!

OK, admit it! I know that there are at least
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
few of you out there who can relate to this! Emotions run high during Christmas season, anyway - and when you a
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
d a 'pregnancy' to it - watch out world!

I'd be willing to bet that there are pregnancy-like hormonal changes that
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
appen to us when we are paper-pregnant! Is there a doctor in the house that can confirm my theory? If not a doctor,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
how about another mom or two?

Whether or not there is a scientific basis for my paper pregnancy theory, the fact re
.

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
ains that parents waiting to adopt experience many of the same highs and lows - plus some. Practice giving grace
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
to ALL expectant Moms and Dads - whether there pregnancy creates a bulging tummy, or a bulging file of paperwork.

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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I Suggest - Adoption: Paper Pregnancy Hormones

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