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There is nothing more embarrassing than waking yourself up with a loud snore. A full night's sleep became a thing of the past and was replaced with morning headaches and fatigue. I was tired all day long

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

and getting through a ten hour work day was getting to be a chore.

I decided to make an appointment with my primary care doctor. I was finally asking for help. My doctor listened to all my symptoms and c

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

Examples of combination products may in

omplaints and looked up from her lap top computer and said that I had sleep apnea and wanted to make an appointment for a sleep study as soon as possible. My doctor explained that sleep apnea was a seriou

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

s medical condition that was characterized by snoring and day time sleepiness. People who had sleep apnea complained of being sleepy and tired. They would snore and stop breathing in their sleep. Frequent

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

y, the spouse wakes up because of the snoring. My husband would wake me up and ask me to roll on my side.

The sleep study was an overnight stay at the hospital in a special area where you were placed in

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

Combination pro

a room that looked very much like a bedroom. They mailed a list of requirements one week before your sleep study appointment. You were to be at the hospital by 6 p.m. and bring either pajama top and bott

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

om or a sweat pant and a loose top. You could bring toiletries and bring your own pillow.

I was admitted to the Sleep Study area of the hospital and was taken to my bedroom. The nurse came in and expl

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

ined that I would be given time to relax by reading or watching television. You could also bring in light snack food and bottled water. About 8 p.m. the nurse came into my room and told me she had to prep

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

are me for my sleep studies. She placed electrode patches on various places on my scalp, face, arms and legs. Then long wires were attached to these electrodes and finally connected to a small bedside mon

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

itor. She also let me practice with a breathing device which was placed over my nose. This device was attached to long plastic tube which was connected to a CPAP (Continuous Positive Airway Pressure) mach

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

ne that was placed at my bedside. The nurse explained that the CPAP machine would flow pressurized air through my nose and keep my airway open when I laid down to sleep. I would also be monitored by a ca

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

Following aspects would a

mera all night and a call light was placed at my bedside, as getting out of bed was difficult due to the wires that were attached to your arms and legs.

Falling asleep wasn’t as easy as I thought it wou

dd to the challenges in developing combination products:

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

ld be. But I drifted off to sleep after a few episodes of tossing and turning. At about 12midnight, I was awakened by the nurse and given the nose piece to put on. This nose piece was held in place with a

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

elastic strap placed over my head by my ears. Falling back asleep with this device attached to my nose was the hardest thing I ever had to do. I had to concentrate on keeping my mouth closed because as s

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

on as I started to fall asleep my mouth breathing habit would take over and I would wake up with the air rushing out through my mouth. After a few episodes of mouth breathing, the nurse returned to my roo

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

m and placed a chinstrap that kept my mouth from opening. I struggled with that chinstrap and needless to say it was a long night. In the morning the nurse gave me some information about my oxygen level

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

Professional from academic institutions, pharmaceutical industries, health care indust

without the breathing device. The normal oxygen level is 90-100%. I was at 65% oxygen level and that is not a good level.

Within a week of the Sleep Study I was using the CPAP machine every night and af

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

er one month of changing nose pieces I found that I could not tolerate the CPAP machine. I was placed on oxygen with the nasal cannula tubing which did not require the pressurized oxygen.

I also learned

.

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

that sleep apnea is a sleep disorder that could lead to other problems such as heart problems. The risk factors related to snoring are heart attack, high blood pressure, stroke, heart failure, and increas

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

Companies that provide selfless information through particip

ed tiredness and sleep apnea.

Do not be afraid to let your doctor know about your abnormal sleeping habits. It could help prevent future health problems and give you a good night's rest and peace of mind

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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