References - Home and Family

Another Easter and another family gathering has come and gone. It reminds me why we don’t do it more often. I don’t know who was worse this time around. Crazy Aunt Janet or Mysteriou

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

s Uncle Earl. By the way, the names have been changed to protect the insane. But there they are, doing what they do best. Making a mockery of everything that’s good and wholesome in

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

Examples of combination products may in

the human race. I look at other family members that appear normal and think to myself. Does every family have the dysfunctional side? The answers seems to be a resounding yes.

I’ve

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

een to other family picnics, barbeques, and weddings. Invariably, someone will pull me aside and point out their “pariah.” It can be the “gay cousin,,” the “anti-social brother” the

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

“gossipy-aunt” or the “grandfather –from-hell” that hates everyone. They then proceed to tell me the latest incident which made them infamous and had them earn their nickname. They a

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

Combination pro

e probably wondering if their family is the only one with wacko relatives.

But the larger the family, the more likely there will be one or two or more. I cringe when mine gets toge

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

ther. It can also include the bizarre in-laws. I have a few that I could write a book (or article) about. They are rude, obnoxious, arrogant, and distasteful. But they are also fairl

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

y rich so that makes it okay. After all, don’t the wealthy get a free pass? They can screw up and say the most outrageous things and get away with it. It reminds me of Mel Gibson or

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

omeone famous that tears apart a whole segment of society. But they are just being “insensitive” or a little “politically incorrect,” so what the heck? Look at all the money and fame

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

they have that makes it all okay to say what ever comes to mind?

One family member was recently convicted of shoplifting. They were caught red-handed by the store detective but hir

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

d a high-powered attorney for half a million or so and got off with just a stern warning. I guess they just pleaded “I’ve got lots of money, your honor” and got the “get-out-of-jail-

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

Following aspects would a

free” card handed to them. But it’s not being rich that can get you respect. If you’re a doctor or attorney, you can make an absolute ass of yourself at a family social event and bar

dd to the challenges in developing combination products:

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

ely get a glance. After all, it’s Dr. Greg or Jerry-At-Law. They must be really smart and so let’s overlook the fact they have the social graces of a howler monkey in heat.

I feel s

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

rry for some of my lousy relatives because I don’t think they know how pathetic they are. My dad, who passed away a few years ago, was one. He said the most insensitive things and hu

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

rt me many times, He was a liar, a lout, but, because he was from England and still had his British accent (although he came to America over 50 years ago) he appeared smart, courteou

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

, and incapable of a snide remark. Yet he was abrasive and abusive and did his best to put down every American he came in contact with. Which was 99.9% of the time. I don’t miss him

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

Professional from academic institutions, pharmaceutical industries, health care indust

one bit, but wish I could have straightened him out during his lifetime.

My point is that we shouldn’t have to put up with relatives that either hurt us, make fools of themselves or

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

are an embarrassment to themselves and family. They should be told and admonished. We owe it to the other relatives to help smooth over the rough edges and attempt to make future fa

.

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

ily occasions a more happy event. That way, we don’t have to focus on Nutsy Uncle Ned farting all the while and Curious Aunt Helga asking me why I’m so fat every time we meet. Instea

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

Companies that provide selfless information through particip

d I can enjoy my family celebrations and go back to just looking down the blouses of the well-endowed female relatives and whistling different bird calls I’ve learned over the years

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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Consider the following: As a trader you are in a business. Your strongest opponent has plenty of capital. He follows a program and he does it without emotion...

From time to time during the life of our home business, each of us will find ourselves in a rut of boredom, disinterest and frustration. We seem to lose that excitement we once had, and find ourselves feeling tired, irritable and unmotivated. We want to hide under the covers rather than face the day. Perhaps you're frustrated because you're not seeing the progress you hoped to, or you are feeling overwhelmed by the number of tasks on your To-Do list. Perhaps you just need to infuse your business with a breath of fresh air.

So what gets into the minds of these guys to make them go out and try and set a world record like this guy who failed by two lives from reaching his goal? Who gives him the idea to do such wicked things. I place the blame squarely on the media for using the term world record and the blood is on the hands of the government leaders who allow the media to use such reporting. Let me discuss.

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References - Do You Have A Crazy Aunt As Well?

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