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I would like to tell you the story of a very special little Chihuahua girl. Her name is Lexie (short for Alexa) and I call her my "grand-puppy. " She came to me through a series of miracles that I believe were orchestrated by my son, Brian Mich

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

ael, before his passing on February 22, 2003. Lexie has brought more comfort and love to me than I can even describe. She has been my constant companion and my live connection with Brian.

Around Christmas time of 2002 Brian started talking ab

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

Examples of combination products may in

out getting a dog to keep him company. He lived alone in my house in North Carolina that he rented from me since I moved to Michigan 7 years ago. Brian had a friend with a Chihuahua, so he started talking about getting a Chihuahua for himself.

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

Brian had asthma and allergies to animals and we had heard many times that Chihuahuas are really good for people with asthma and that they do not affect people with allergies like most animals.

So just before Christmas in 2002, Brian called me

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

in Michigan and told me that he had a new Chihuahua puppy. I didn't believe him and he just said "you'll see when you get here." My husband and I always drive down to NC on Christmas Eve night and I could hardly wait to get there this year to

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

Combination pro

see that new puppy - although in the back of my mind I kind of thought Brian was just kidding with me. It was a long drive!

When we arrived on Christmas morning I ran into Brian's bedroom where he was sleeping and pulled back the covers a litt

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

le to see if there was a little puppy sleeping with him. Not! Brian just grinned his beautiful grin and I knew that he had gotten one over on me - again!

My husband Dennis and I stayed with Brian for about two weeks after Christmas and then D

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

ennis flew home to Michigan and I stayed for a few more weeks. During that time Brian kept suggesting that I buy him a Chihuahua. So, one day my sister and I were shopping and I had an urge to start looking for a Chihuahua. We were in one sto

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

e and they had little doggie beds on sale and I was just compelled to buy one. I told the woman at the counter I was thinking about getting a Chihuahua and she said that her sister breeds Chihuahuas - and her sister was in the back of the store

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

.

Her sister came out and gave me her telephone number because she did not have any puppies available at that time. Through a series of calls to her, one thing led to another and soon I had found a local breeder with puppies available. The br

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

eder brought two puppies to Brian's house for me to see. It took about an hour to choose the puppy, and I knew which one to choose when the very pale colored puppy crossed her front legs.

You see, I had a chocolate labrador named Coco for many

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

Following aspects would a

years and she always crossed her legs when she was lying down. So I took that as a sign from Coco that this was the right puppy for me. She weighed one pound and I could put her in my pocket or in the sleeve of my coat. She was so adorable.

dd to the challenges in developing combination products:

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

When I brought her home to Brian he was thrilled and right away named her Alexa and said we will call her Lexie. He could hardly wait to get home from work every day to play with Lexie. We bought teddy bear sweaters for her to keep her warm -

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

even they were too big. My favorite was a pink sweater and when we put it on her, she just fell right over because the sweater weighed more than she did!

Over the next week it became apparent that this little puppy might require more time and

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

attention (like 24 hours a day!) than Brian had to give and we were already considering bringing her home with us to Michigan temporarily until she was a little older and did not require so much attention.

As it turned out, Brian passed over on

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

February 22 (you can read the story of Brian here - http://www.BrianMichaelGuthrie.com) and we did eventually bring Lexie home with us to Michigan.

I know that Lexie is a gift from

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

Professional from academic institutions, pharmaceutical industries, health care indust

Brian to me - the only "granchild" he would ever be able to give. Brian was 26 years old and had not yet married, so with him went the chance of grandchildren. When I mourned for Brian I also mourned for the grandchildren I will never have.

I

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

am eternally grateful that Brian orchestrated the events that led to Lexie coming into our lives to provide love and comfort. We have since added another Chihuahua to our family name Mikey and he is also a joy and comfort. Lexie loves having

.

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

little brother!

So, that's my story of how Lexie came into our lives and one of the miracles that have occurred before and since the passing of my eternal son, Brian Michael.

Pay attention to the events in your life and always remain open to

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

Companies that provide selfless information through particip

Divine direction.

I stay divinely connected by, among other ways, going outside and lifting my open arms to the sky and saying out loud, "I am open to receiving Divine direction."

Thank you for caring and sharing the Miracle of Lexie Chihuahua

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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