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"I'm really frightened about my upcoming hysterectomy. I'm anxious and have butterflies in my stomach all the time. What is wrong with

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

me?"

Fear is a natural emotion that is hard-wired into human beings. Having any surgery can be a scary proposition, so it stands to re

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

Examples of combination products may in

son that you would feel nervous about having a hysterectomy. You are not strange, weak or unusual if you are afraid to go to a hospital

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

for the purpose of having your body cut open to remove organs. If you are experiencing pre-op anxiety, you are 100% normal.

There is n

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

o sure-fire remedy for eliminating pre-op jitters and sizzling nerves. But we do have ideas for managing the “waiting time” in a number

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

Combination pro

of different ways….ideas shared with us by members of the Hyster Sisters community: Clean your house from top to bottom…that is to say

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

really clean it! Prepare “meals for the freezer” for re-heating and consumption in your early post-op weeks. Set up your recovery ro

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

om and make it as comfy and convenience-filled as possible. Socialize with family and friends. Go out and physically “do” things like

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

walking, boating, bowling, dancing, etc. Physical activity can help to relieve stress and promote a good night’s sleep. It is comforti

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

g for some women to pray, attend worship services, and request prayers from members of their congregation. And, although it can seem mo

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

bid to some, quite a few Hyster Sisters have relieved a bit of their anxiety by writing letters to their children and others loved ones

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

Following aspects would a

, to be opened “just in case.”

It’s natural for hysterectomy patients who are mothers to try to “protect” their children (even if they

dd to the challenges in developing combination products:

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

are adults) from developing their own fear and anxiety about Mom going to the hospital to have an operation, so consequently they may c

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

nceal their emotions from their children. Other women don’t feel comfortable sharing their fears with their spouse, siblings, or anyone

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

. They don’t want to worry or burden anyone, so they downplay everything. This concern is very understandable, but it would be much mor

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

emotionally healthy to share your fears with even just one “confidante.” Don’t keep it all bottled in. You need to talk about it openl

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

Professional from academic institutions, pharmaceutical industries, health care indust

with someone…even if it is just one person.

If you are suffering terribly from pre-op anxiety, and can’t seem to calm down from tryin

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

g the remedies we suggest, do talk to your doctor about what you are experiencing. It won’t be the first time your doctor has heard abo

.

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

t this from patients facing surgery! Perhaps you can be prescribed a light sedative to take “as needed” until your journey to the Castl

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

Companies that provide selfless information through particip

. Don’t suffer needlessly. You need to be well-rested and as emotionally-fit as possible when you embark on your journey to good health

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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