One of the most frightening things about melting from a normal, Solid, ego-based lifestyle, to a more Liquid, dynamic, spiritual one is that some concepts that you always assumed to be sound and good and true, start to lose their solidity. The very glue that h
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
olds together this solid, stable world begins to lose its cohesion. For example, take the simple concept of "self-control." You have control of yourself. You are in charge of your Destiny, the Captain of your Fate, the Master of your Mind...
Aband
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
n all hope, ye who enter here. Beyond these words lies madness. Madness to the Ego - Danger to the Me Story that you hold so dear. The very foundation of the dam is starting to crack. Do you really wish to stress it more? To destroy the dam will free the River of your Soul, but the dam, once in ruin, can ne
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
er be rebuilt.
Control. A simple enough concept, but let us look a little closer, let us brush away the dust and cobwebs from this ancient box. Let us lift the lid and peer inside. Let us find the secrets hidden within. Let us look closely at an assumption
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hat is as old as the hills - the assumption of self-control.
Why do you continue reading? Before proceeding, answer this question truly. Why are you reading this article?
What controls your actions
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
not "re-actions," but conscious, "I decided to do this" actions? Without a thought you answer, "I do." Now thousands of philosophers have tried to deconstruct the "I" in "I do." So let us not waste our time with that old, and ineffective argument. Let us take a more direct approach. Let us simply watch our
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
thought process. First - Remember a decision you recently made. You chose "A" over "B". Take your time and remember it. It may have been a difficult decision, you may have had a number of arguments for each side of the problem, but if you look closely, you'll realize you decided to pick "A" over "B" becaus
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
... you wanted to. Something in you "felt" this was the best decision. Simple as that. All the practical reasons, all the logic, all the rational arguments were used by your mind to make yourself "feel" better about "A" than about "B". You chose "A" because you liked that option better than "B".
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
font-family: "Times New Roman"; font-size: .9em'>Why are you reading this article? In your answer, were there the words, "I want"?
Desire. Desire IS Life. It is what motivates the body, mind, and soul. Without desire, we would just watch - there would be no
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
eason to do anything. I want. I want. I want. Desire drives the mind. Desire drives the body. Desire is the captain of our soul.
Behind your eyes, behind your thoughts, behind your desires, your hopes and your dreams, there lies a stillness, an aw
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
reness, an opening. Still, aware and open - no action, no trying, no doing - no wanting. Within this stillness there lies only... a Watching.
Decisions are made because they feel right. They feel right because you were raised with certain values, you have ce
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
rtain lusts, you have compassion and selfishness and anger and envy. Can you help what you want? Do you control what you love? Can you make yourself happy while watching an animal suffer? Desires arise from our primal nature - filtered through our value system they drive our emotions and thoughts. Desires a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
e uncontrollable. We may think we control our actions, but all we are doing is satisfying one desire in lieu of another.
I want a relationship and I want my independence. I want to eat chocolate and I want to lose weight. I want to live the good l
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
fe and I want to quit my job. Desire pulls, desire motivates, desire inspires - Desire controls. I want to be responsible and I want to be carefree. I want to make my family happy and I want to be alone. I want to be selfish and I want to be compassionate. I want, I want, I want.
As difficult as it may be to hear, every decision you have ever made, you chose the option that felt better. Even the most horrible, awful, painful decisions - you chose "A" over "B" because "A" made a part of you (the compassionate, loving part?) feel better than choosing "B". Look at
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
any decision you have made. Look at any reaction you have experienced. Look at every movement of your body. All movement, all actions, all Life, is driven by a desire for something better.
You're not in control. Nor is your neighbor, or boss, or l
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
over, or your dog or the driver cutting you off in traffic. All creatures act on an inner pull, the tug of their desires. We cannot help the way we feel - we cannot help our urges. Our minds rebel, our egos fight, but these, of course, are just more desires.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
What controls your actions? What controls your thoughts? What controls your deepest emotions?
I want, I want, I want - The Blessing of Life. The Foundation of the Ego. The ripples upon the still and Ethereal Lake.
Can you watch the natural desires arise? Can you see them twitching the strings of your life? They pull a string and you turn left. Another and you buy a house. Another and you sit upon your meditation cushion. They are not you, they are what happens to your body - to your story. They are no
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
you, they are the life that You experience. They are the ripples upon Your lake.
Watching the desires arise, the sage relinquishes control and, like an autumn leaf upon a forest stream, floats happily upon the gentle currents of his worldly life.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
When you shop for a mortgage loan you have several options for the type of mortgage lender you choose. It is important to shop from a variety of mortgage lenders and brokers to find the most competitive loan offer for your financial situation. Here are the basics of mortgage lenders and where to shop for the best mortgage.
The Iranian President met with Iraqi leadership and offered full support in establishing security stating the Iraq's security is Iran's security? But why would a leader of a nation state, which sponsors international terrorism and who is in super hot water with the United Nations and Free World make a promise that he cannot keep.
Obesity has become a health hazard in masses of all ages, there are several ways to prevent it or cure, hereby I am discussing few points regarding obesity cure.
