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A topic of interest relates to a dog, Sassy, who I take out walking Saturday's and Sunday's. When I took up the assignment, I was warned about the dog, a Jack Russell Terrier, and her beha

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

vioral problems. Avoid other dogs, hang tight around squirrels, she's very aggressive, and so on. Everything I heard sounded wrong; it didn't sit well with me as I listened to all of these

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

Examples of combination products may in

instructions. Curious and rebellious towards the negative perceptions I decided to observe what was going on with Sassy rather than take everyone's word. This results in a remarkable stor

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

y of transformation.

The first couple of walks I proceeded cautiously, allowing her to experience close-calls with other animals so I could observe what was happening. Then I purposely al

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

lowed contact during subsequent walks, always being cautious and watchful around her behavior. Oddly, with some dogs she reacted and others she didn't. When she did I would assert Alpha do

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

Combination pro

minance - canine pack behavior - and let her know it was wrong and immediately followed that with comfort that everything was fine. This also included me greeting and engaging with the oth

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

er animal so she understood fully from the experience that her safety and my safety were not in question.

In addition to this, this Jack Russell was only managing to get a 30 minute walk,

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

morning and evening, for minimal exercise and a bathroom break. This is insufficient physical, mental, and emotional stimulation for the animal. Even though only paid for 30 minute walks,

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

I took it upon myself to go further, expose her to more stimulii and activity. We discovered she loves swimming in the ocean, she loves chasing balls and sticks - the sticks she loves to

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

chew into bits & pieces too. I even discovered towards the end of our time working together that she manages just fine off-leash and will follow along long walks with rarely a mishap - she

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

is a dog who loves chasing squirrels after all. Sassy, I'm told, is 13 years old and we've all been told you can't teach an old dog new tricks. Well, guess what?

Not only did we experien

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

Following aspects would a

ce the transformations mentioned above, we also watched her confidence and a calmness return to her reality. All she needed was someone to take leadership with her and to observe and under

dd to the challenges in developing combination products:

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

stand the emotional response - flight or fight - that was occuring. Knowing the reason for the emotional response offers insight - not really necessary to bring about change - and patient

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

love and attention turned it around. As all those immediate concerns vanished, we could venture on walks and take on new adventures. This is where, in addition to the transformation she'd

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

already experienced, I began to do some obedience training and to teach her new tricks. In two very short weeks she would roll over on command about 80% of the time. Who says you can't tea

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

ch an old dog new tricks?

People make assumptions and adopt beliefs all the time about what is happening in reality. Just because there seems to be a justification for the situation (the

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

Professional from academic institutions, pharmaceutical industries, health care indust

Jack Russell had been viciously attacked in her younger years), there is always a cause and effect at play that can be challenged and transformed. This experience resulted in a remarkable

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

story of transformation that is really nothing like a transformation at all. It's more of a coming home and being as a dog is meant to be. This causes me to think of what it means to be hu

.

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

man, what we're meant to be, and what might happen if people really had the freedom in their lives to be that picture of freedom and playfulness, or authenticly being. Better yet, what if

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

Companies that provide selfless information through particip

we slowed down enough to offer the attention and authenticity with each other, our families, our children, and our colleagues? Enough with the meds already!

More another time. Peace & Lov

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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