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Autism. I heard the diagnosis but my heart raged against what my mind knew to be true. I was aware of the possibility as the signs were clear, but still I was devastated. But such was the situation that despite being a world renowned brain specia

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

list and an expert in communication problems, I faced a blank wall becoming simply another mother faced with a difficult diagnosis.

I clearly remember the day I was in the hospital about to give birth to my third child. The contraction inducing dr

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

Examples of combination products may in

gs had been administered and I excitedly looked forward to meeting my new baby. I focused on my breathing, the doctor's instructions and the fetal heart monitor. Suddenly, the room cleared and the doctor spoke. "The umbilical cord is wrapped aroun

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

the baby's neck four times…listen carefully to my instructions," he paused. "Cheri, this is the hardest thing you will ever be asked to do." A few months later, I was beginning to suspect that wasn't true.

Whitney seemed to have no emotional resp

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

nses. While the other older children would cuddle with me, their youngest sibling was lost in his own world. It was as if he was a shell for whom his parents or siblings did not exist.

Having worked with thousands of stutterers, apraxics and strok

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

Combination pro

patients as well as children with delayed language, I was faced with a major question. Did Whitney have a disease that would need a cure or did Whitney have a group of symptoms that could be trained. If I could figure out the symptom clusters as

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

had done with the other communication disorders, then perhaps, Whitney could learn to become symptom free.

I discerned a pattern—Whitney, had a knack of returning to places he had been to earlier. He was also always ripping apart his toys and exa

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

mining their working. Most importantly, he was problem solving. This was no mentally retarded boy. He seemed to accessing his visual memory and his visual mechanical thinking.

My 15 years of research before Whitney’s birth had fine tuned my mind

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

o catch the pattern –this would be the way to pierce the walls of silence surrounding my darling son. My other children, Vanessa and William and I worked together to reach William through his silent visual world.

Soon a new educational system soon

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

evolved. The educational tools were pictures, videos, logos. I discovered that many children with symptoms of autism were also highly visual and have at least one highly visual parent.

Both parent and child think in a color world of images rather

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

han words. The parents are in fields like engineering, architecture, medicine, computers, art, and business. They are extremely capable of intelligent thought and communication but they think in pictures first and then convert to words. The autist

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

Following aspects would a

c child of the visual parent may have visuals that are over-working to the point that language in under developed or as in Whitney’s case non-existent.

This inability to process and produce language can lead to onset of as many as 50 symptoms in b

dd to the challenges in developing combination products:

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

havior, coping and communication. From Whitney’s change profile, I isolated symptoms that characterize prognostic predictors of becoming symptom free.

Our goal for Whitney was to help him become symptom-free and to enable him to become his own adv

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

cate. Soon my son was telling a committee, and winning his argument, that he no longer needed special education support. Whitney was right. By high school he was one of the bright kids of the school, playing championship football for an outstanding

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

team, winning state honors in science and acting and producing plays.

Now Whitney is studying for his degree in Chemical Engineering in New York City. To hear Whitney tell his own story go to www.ebrainlabs.com

The mother in me struggled agains

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

the doctor in me when considering -whether to share my family’s traumatic experience with the world or let it be a closed chapter. This was particularly so as the topic was unpleasant to Whitney. The mother wanted to protect my child and honor hi

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

Professional from academic institutions, pharmaceutical industries, health care indust

wishes but what of the other mothers who were enduring this challenge?

Whitney, himself, reconciled this dilemma for me as he feels strongly that his story should be used to help others. He and his siblings helped me write a book Maverick Mind. T

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

e book’s revelations of my path breaking discovery were hailed by the scientific community and harried parents alike. The visual thinkers or Highly Visual Minds are now called Mavericks.

In the video, Understanding the Maverick Mind (www.ebrainlab

.

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

.com), Whitney’s older brother William explains the method, “The visual thinking system is so strong that we harness it by training that it can be completely independent of language. Mavericks improve when we are able to teach the visual and verbal

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

Companies that provide selfless information through particip

thinking systems to work together in synergy, molding the two systems to function as companion partners. As the harmony between these systems increases, we can teach the verbal system to work alone, which allows the Maverick to become symptom free.

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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The FDA needs to reduce its rules and regulations to help the market place participate in capitalism and help the consumer and the American people so they can enjoy lower prices, better quality products and safer foods.

The first step to becoming the confident guy you've always wanted to be is to close your eyes and imagine every aspect of his character. Without a very vivid picture of who you want to become, you'll never become him.

First of all, we have to abandon all our misconceptions about life, so that we will be able to learn the truth about human nature and the world we live in. We have to understand that what we consider as being logical may actually be absurd- we may not be able to perceive this because of our ignorance.

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