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Do you know how much energy is required to sit and be alone with yourself? It is very easy to say, but have you ever been able to sit with clarity and hear your truth?

I live with two men of Italian heritage. Larry, 26 years my senior and, Jimmie, my 18 year-old, track and field phenom, step-son. Three dogs, 2 boys: Coco 15, Rocco almost 2, and female, Sasha, the 12 year-old, whin

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

ing, spoiled, adored by all, sweet, German Shepard. Three cats: Kieran (yes, that is a boy's name), Keeva and Keegan. I am exhausted.

I used to be a computer professor. I quit that job which infuriated and/or frustrated everyone in my world. Larry, Jimmie and I have been diagnosed and are beyond any shadow of doubt, ADD. No excuses, please, I despise blame placing. Just try to ima

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

Examples of combination products may in

gine for a moment the whirlwind of thoughts and stimulus that is thrown at you daily, understanding, but not grasping and trying to keep up the only way you know how- scattered. Now, imagine two men and one woman living together, each with their own strengths and weaknesses, each scattered and trying to live up to the really good people they always intend to be.

Finally, finding a

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

n answer to the processes of my brain, chemically managing it (I will debate that issue in another article), nearly killed me. Self-knowledge can be detrimental when learned alone. Raising myself up from the mess of a life unprocessed and ill-organized, bringing up puppy, Rocco Pacifico, with zero experience: mothering a teenage boy, wife-ing, cleaning and cleaning and cleaning(th

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

e most exhausting). Nausea, fear, anxiety, denial, fix this over here, run to fix that over there, defining boundaries and rules as an individual, family and business woman; strong enough to make changes happen for everyone, always succeeding in the past, but now I was too weak to find any insurance of progress. Yes, just thinking of going back to that plush job, teaching something

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

Combination pro

I didn't want to teach- "Professor Patty teach us this, teach us that, you're the best"- No! I can't take anymore. Going back to more work would have killed me.

Real life work nearly did the same. Going somewhere other than a room in your home to work is tangible and understood. Mothering, wife-ing, managing a house, creating and managing a business, dogs, cats, local celebrity

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

and all the wonderful gossip that entails, making numbers work, each day finding a way to resolve and organize so many things others don't see, including all my personal mismanagement, is not tangible and difficult for others to understand and appreciate. I believe completely, that my years of choices lead to my inflamed gall bladder which seeped enormous amounts of fluid covering

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

all my core organs- no history of any issues and a complete shock and mystery to my surgeon. Then came an extended recovery- Doc: "You got so much abdominal muscle and little fat that it was difficult to get to your gall bladder and your recovery will be twice as long." Even keeping in shape slapped me in the face. Of course, life didn't slow down, infection set in, four weeks afte

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

r surgery it was starting into my kidneys. Intense back pain and panic attack led me to the emergency room doctor who dismissed me as a low-life sending me on my way with muscle relaxers and pain pills. The next day, my wonderful family practitioner took care of me like a human being and now all my physical pain is gone. But, I'm still exhausted and yes, it is all my fault. More im

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

portantly, it's all my choice, and they have been enlightening and educational. They taught me how humans find hope and perseverance.

Teaching was never a work issue. It is my gift. The subject I was paid to teach was not what I really wanted my students to learn. I see ideas and words, not numbers. Numbers- God, please no more numbers! Even when I would teach binary math, those n

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

mbers used to stress me out. I can't do math in my head and I have to check and re-check all my written equations. I would always goof my math in front of my students. It was good for laughs and levity of a dry subject. Now, I constantly have numbers on my mind- age, debt, hospital bills, dog prescriptions, gasoline, website traffic- numbers, numbers, numbers. People like numbers o

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

Following aspects would a

n paper. It is something they can see; something tangible and proof from which they can learn and associate. Bank statements, paychecks, coins, paper money. Proof of numbers that show tangibles and worth- seeing is believing. Like I said, my mind doesn't see numbers, it sees ideas and words. This leads to my persecution of not being grounded and practical. However, it is an idea an

dd to the challenges in developing combination products:

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

d words that start the process of tangibles and numbers and there are many practical ways that lead to the showing of numbers.

Every self-help book, website and individual will give you a hundred different ways to get to the same answer- your truth. I have my bible-thumpers who judge me for my growing up and change- me for who I am and should become. To them I say:

P1581:1, 140:8

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

.14 The family occupied the very center of Jesus' philosophy of life -- here and hereafter. He based his teachings about God on the family, while he sought to correct the Jewish tendency to over honor ancestors. He exalted family life as the highest human duty but made it plain that family relationships must not interfere with religious obligations. He called attention to the fact

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

that the family is a temporal institution; that it does not survive death. Jesus did not hesitate to give up his family when the family ran counter to the Father's will. He taught the new and larger brotherhood of man -- the sons of God. In Jesus' time divorce practices were lax in Palestine and throughout the Roman Empire. He repeatedly refused to lay down laws regarding marriage

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 divorce, but many of Jesus' early followers had strong opinions on divorce and did not hesitate to attribute them to him. All of the New Testament writers held to these more stringent and advanced ideas about divorce except John Mark.

Parents, sons, daughters, wives and husbands, every moment, day and year of your life you make decisions based on what you believe and know at t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he time. Sometimes you make those decisions with so much clarity and knowing, that life works itself out- even when there were/are rough spots along the way. Sometimes, what you know now would have worked life out differently. Now that I have lost my rose-colored glasses, everywhere I go I see people stuck in the decisions they wished they could change, the idea of someday doing wh

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

at they say, but mostly saying all the things they will never do. They are all smarter than they think. They just have to simply find their religion- continuously doing what they know and feel is right inside, where family exists and extends to those who are of our blood or not- our real family.

I have climbed my way out of my ditches- dug by my choices, reactions and lack of know

.

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

ledge. I am still climbing out, getting kicked constantly by damned numbers. Yet in all my judgement, labels, fear, sin, and the thoughts of "crazy" I hear from my friends and family, I have taken the time and immeasurable amount of energy to sit alone, hear and fight to accept my truth.

It's very easy to say, extremely difficult to do- you will face nearly every fear and the har

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

Companies that provide selfless information through particip

dest battle of life is with yourself. With all my "doing" I realized I was still just talking about other things I want or need to do, and not saying the one thing my world needs to do, so the world can discover a teacher who will find, study and learn all the different ways to see, so she can finally teach what she wants- "Get off my ass! I'm living honestly. Why don't you listen?

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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Have you ever purchased a coffee from Starbucks? How come they can charge you five times what it’s worth and we still go and buy it? Ever wondered what’s going on here? Well, the reason is: they are not just selling coffee – they are selling us a lifestyle.

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