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Recently I come across the following scale in a national research report to grade each state’s education performance within numerous areas. Do you see anything questiona

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

ble about this scale?

Grading Curve: A (93-100), A- (90-92), B+ (87-89), B (83-86), B- (80-82), C+ (77-79), C (73-76), C- (70-72), D+ (67-69), D (63-66), D- (60-62),

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

Examples of combination products may in

F (0-59)

If you aren’t scratching your head yet, please allow me ask another question. If you are an employer, a human resource or a quality control manager what expect

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

tions do you have toward the performance of your employees? In other words, do you expect your employees to know 50%, 60%, 75%, 80%, 90% or 100% of their job skills or job

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

escription? At what level of knowledge and years on the job, would you consider that employee’s performance to be sub-standard and would not entitle her or him to a promoti

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

Combination pro

on or a raise and might be within the area of specific discipline strategies from suspension to termination?

Now you might be thinking what is this lady talking about. Com

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

on sense dictates that every employee should know at least 75% or 3 out of every 4 requirements of their job and within a certain time frame progress to 100%. Errors are co

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

tly in business and employees’ errors are extremely expensive as they have a cascade affect within the organization.

Even though the above scale is for a national research

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

eport on education in America, this scale is present in many classrooms throughout this country. What has happened is that the low expectations within the classroom have mig

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

rated up and now are affecting research organizations that consider 60% as passing. F is failing and everything above F is passing. From a simple performance perspective,

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

if we don’t fail, we have success because success has been defined at 60%.

These low expectations have contributed to the low results that have been documented through

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

Following aspects would a

uch research as the National Assessment of Educational Progress where for example reading scores collective

dd to the challenges in developing combination products:

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

y for 17 year olds over the course of 33 years have not changed.

The high standards of 40 plus years ago where anything less than 75% was failing are non-existent in the ma

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

jority (that being over 50%) American schools. NOTE: As a former school board trustee, I continually fought to raise the bar to 75% as passing, but that outraged t

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

achers, parents and students who argued such standards would prevent the students from playing sports. For playing sports was no longer a privilege, but a right.

Many y

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

ung people experience 12 years of conditioning where doing less than your personal best is OK. And guess what? You even get rewarded by a promotion to the next

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

Professional from academic institutions, pharmaceutical industries, health care indust

grade. How cool is that? Now, these same young people go into the workforce with a belief that it is OK to just get by as long as you don’t fail. Duri

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

ng my 20 years in management, I saw this on a regular basis with many of our new hires.

If we, as business owners, truly desire to improve the performance of today’s employ

.

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

es, we need to raise the standards within both the schools and the organizations that report on the schools’ and states’ performance. Until we stop this cycle of mediocrity,

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

Companies that provide selfless information through particip

we will continue to receive employees who expect the world without working hard at acceptable levels of performance. And these employees will continue to view 60% as success

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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Everyone has tried to save money by not hiring a professional graphic designer to produce their newsletter, business cards, or any other print material. Well, there are reasons why they don't turn out as well as you had hoped.

Most directory ads have various flaws and reasons they fail. It's your job to find out what they are.

Most of us spend more time AT WORK then elsewhere. If you're like the rest of the working stiffs... it's about 60% up to 70% or more of your time either traveling back and forth plus 8 to 12 hours on the job for your employer. We call that full-time.

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