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Since I gave up my job eighteen months ago and became a stay at home parent to my son, I have been a member of a wonderfully supportive online forum. We chat about many things but our children, being

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

such a big part of our lives, are probably the main topic of our discussions. Every day there are posts about first smiles, first steps, cute things they have done – all the little things that make

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

Examples of combination products may in

otherhood wonderful. But the anonymity of the internet encourages a frankness and honesty that you wouldn’t necessarily encounter in ‘real life’ and there are also plenty posts about the less enjoyab

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

le side of parenthood. From this I have noticed one thing that all mums have in common. We feel guilty an awful lot.

Being bored

Caring for a baby or child can be a lot of fun but there’s no

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

denying it can also be incredibly monotonous. Changing nappies (diapers), feeding your baby, trying to get them to sleep and singing endless nursery rhymes day after day can get repetitive, and leave

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

Combination pro

many parents feeling a little bored. And that is when guilt can set in. Surely you should love being with your child?

Think about a job you are doing now or have done in the past. Did you enjoy it?

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

If you’re lucky the answer is yes. But even then there were almost certainly days you were bored, wished you were elsewhere or decided you needed a holiday. Parenthood is much the same. Needing a br

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

ak sometimes doesn’t mean that on the whole you aren’t enjoying parenthood and it certainly doesn’t make you a bad parent.

Baby bumps his head

Not much makes a parent feel worse than when t

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

heir child has a bump or fall that could have been prevented. For instance you may have carefully placed your non-crawling baby in the middle of your bed thinking they would be fine but three seconds

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

after turning your back there is a thud and a lot of screaming. If this happens, check your child does not seem badly hurt and keep an eye on them for a while to check they do not become nauseous or

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

nusually sleepy.

The huge majority of children, however, are absolutely fine after a little fall and there is neither physical nor emotional damage. It is also a very common occurrence. I’m not sayi

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

Following aspects would a

ng that it happens to every parent, but it certainly has to every one I’ve ever met. You’re bound to feel bad, but don’t dwell on it. Unfortunately accidents are always going to happen.

Shouting

dd to the challenges in developing combination products:

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

t your baby

Obviously shouting and swearing at your children on a daily basis is not acceptable behaviour. But losing your temper once in a while is going to be unavoidable. For instance, if the

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

y are being completely honest, a lot of mothers will admit to the rare occasion when they have shouted at their screaming baby at four o’clock in the morning, after they have been up all night becaus

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

their baby just won’t sleep. The guilt is almost instantaneous; after all, the baby is already distressed and isn’t deliberately trying to annoy its parents.

But again, this is not something you sh

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

uld dwell on. The baby probably didn’t notice, certainly won’t remember and it definitely hasn’t emotionally scarred them. Unless you are superhuman or a saint, a baby is going to push you to your li

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

Professional from academic institutions, pharmaceutical industries, health care indust

mits sometimes and you need to accept there will be moments when you will lose your temper. However, if you become so stressed you are afraid you may harm the baby contact a helpline such as Cry-sis

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

nd talk to one of their advisors for help.

These are only a few of the examples I have come across – and experienced – of parental guilt. Next time you are feeling guilty and like you must be a terr

.

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

ible parent, ask yourself this – why are you feeling guilty? Is it because you want to do everything you can to make sure your child is happy and well cared for or you want to be a perfect parent to

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

Companies that provide selfless information through particip

hem? A guilty parent is a good parent, because they really care about their children. So next time you are feeling bad, remember what a fantastic parent you are and also that you are not alone

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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You'd think that something so important to one's eternal future as to the who, where, when, how and why's of Jesus, would be more easily understood and clearly known. Some would say it is, as all you need to do is read the Bible and do what it says. Of course, millions do that and manage to come up with thousands of ways to be or not be, and things to do or not do based on the same text. Let's face it. Where two or three who want to do what Jesus wants' them to do are gathered together, there is confusion and arguments. It has been that way since Judas kissed Jesus in the Garden between those who speak for Jesus. One thing is sure. We will look back on the Da Vinci Code as a movie that was not really entertainment, but rather, an open door to question what so many suspect but dare not say or think. By the many, I mean the average church going seeker.

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