Thesaurus - Self Improvement

Clutter? What clutter? My friend Chris eliminated a major portion of the deeply entrenched clutter in her mountain home, something she has intended to do for years! How did she do it? By doggedly, persistently, taking small, do-able steps over

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

the course of about 6 weeks. She eradicated the piles of papers on her floors and recycled the extra furniture and clothing that she no longer liked or used. She bought color-coded storage systems – drawers and bins and folders – and labeled and

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

Examples of combination products may in

used them. She completed items on old lists and got rid of the lists; she kept newly cleared surfaces clear. As she persisted in this project, week after week, something new emerged.

Her intention to "get rid of clutter" was replaced by an energ

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

zing desire to bring beauty and harmony into her home. This powerful positive inclination toward order, simplicity, and esthetics took on life and momentum of its own. The universe kicked in and began to cooperate with her. She became even more m

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

tivated and effective with this additional energy.

Huge accomplishments are the result of a long series of small steps.

Individually, these steps look and feel quite humble. But do not be fooled!

The Mighty Baby Step is THE essential building

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

Combination pro

lock of personal transformation, growth, and change. It is enormously powerful and available to each of us, every day.

The most important step in any project is always the NEXT one. That's where your power is; that's why I named my first n

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

ewsletter "Next Steps News." STAY PRESENT WITH THE TASK AT HAND. Honor the Mighty Baby Step in front of you and honor your intention to complete it. Resist the temptation to get overwhelmed by the bigger picture: just don't let yourself go there!

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

During my cycling training, I tended at first to be overwhelmed by big hills. As I'd start uphill, I would look up and think, "Whoa, that's steep! And long!" Being daunted by the hill made my actual ascent more difficult than it had to be; I wou

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

d struggle all the way up. I learned to stop looking at how steep and how long the hill was, to keep my attention glued to the present. "THIS pedal stroke is fine, I can totally do this. I have breath and stamina in reserve; no problem, really. I

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

even have a couple more downshifts in reserve if I need them. . . . And now THIS pedal stroke is fine. . . ." And so forth. After a short while I was just pedaling up the hill, breathing into my level of exertion, noticing the wildflowers on my r

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

ght, appreciating the breeze, wondering whether I'd overtake the rider ahead of me. Letting go of the fear helped me just DO the next step.

I also tended to get daunted by the big picture. I would think, "54-year-old slightly overweight non-at

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

Following aspects would a

hlete woman will ride a 2-day cycling endurance event. How likely is that?" When my mind went off in that direction, my job was to bring my attention back to the immediate challenge. On any given training day, I wasn't DOING the 2-day endurance ev

dd to the challenges in developing combination products:

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

nt. I was doing TODAY's 30-mile ride or today's hill drill. Or watching TODAY's food intake. That's all. And today's challenges were always manageable.

The next step inevitably has its own challenges - you don't need to add negative emotion to it

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

That kind of emotion just creates more work. Clear the clutter from your head, and JUST DO THE TASK. Left, right, left, right. As much as you like to analyze . . . there comes a time to just do it, thank you, Nike. Once in motion, you are likely

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

to generate positive emotion and energy which can inspire, fuel, and profoundly support your continued action.

WHAT ARE YOU WORKING TOWARD? Is your goal better health? Every step you take in that direction makes a difference. Every time you fo

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

ego salty fried food in favor of lean protein or lightly prepared veggies – every time – you move forward toward your goal. Every time you go for a brisk evening walk instead of sitting around, you are taking a Mighty Baby Step. These small moves

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

Professional from academic institutions, pharmaceutical industries, health care indust

are cumulative, and over time they land you closer to your goal than if you had not taken these steps at all.

COACHING TIPS

1. Know what your goal is. Put it into your own words.

2. Know what the next step toward that goal is. Go as small

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

nd local as you need to! (For me, this was, "Do today's ride." Or closer-up: "Get up this hill." Or even closer: "Take this pedal stroke.")

3. Take that next step.

4. Go back to 2 if you can, or if you've forgotten what you're doing

.

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

go back to 1.

5. Support yourself along the way:

a) Keep yourself un-daunted.

b) Credit yourself for being in the game.

c) Know that every step counts. Remember the tortoise and the hare.

d) Honor where you are in the process, and do

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

Companies that provide selfless information through particip

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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