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It is difficult to find active birth teachers where I live, they get booked up quickly, so I thought I’d give the local clinics antenatal class a try. I

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

t left me furious for a week and I decided never to return! Why the anger? I knew I wanted a drug free home birth, and I knew the best way to get what I

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

Examples of combination products may in

wanted was to trust in myself. The class set up such a fear of labour that one woman was wincing every time the word itself was mentioned. The emphasis

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

as on how to control and stop the pain with drugs.

Labour is nothing to fear, Websters dictionary describes it as ‘to do one's work under conditions wh

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

ch make it especially hard’. It is hard work and it can hurt a lot, but being scared of it will only make it hurt more. Dr. Grantley Dick-Read coined th

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

Combination pro

phrase ‘fear-tension-pain cycle’ in the 1930’s and that’s exactly what happens. You fear being hurt, you tense up and blood and oxygen is drawn away fr

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 organs that are not needed to flight or fight. Dr Dick-Read said that a scared woman in labour has a white uterus, and a blood free womb just doesn’t

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

have the energy of a nice rich red one, so it hurts.

I don’t know why I wasn’t scared, it might have been just sheer contrariness. It may have been tha

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

I was immune to birthing horror stories, because it seemed as if every mother on my street wanted to tell me about their 48-day labour, or how the midw

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

fe had to chainsaw them open to get the baby out! I was probably not scared because I truly believed that normal childbirth is a natural process instead

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

of a medical one. I was also busy being truly terrified of how to deal with the baby itself when it arrived.

I think I discovered the fear-tension-pain

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

Following aspects would a

cycle for myself at the dentist after a root canal job. I realised afterwards that I had made the whole thing so much worse for myself by being so stre

dd to the challenges in developing combination products:

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

sed. The next time I went, actually to have the tooth out, I recited in my mind the Litany against Fear from Frank Herbert’s book ‘Dune’

I must not

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

fear.
Fear is the mind killer.
Fear is the little death that brings total obliteration.
I will face my fear.
I will permit it to pas

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

over me and through me.
And when it has gone past I will turn the inner eye to see its path.
Where the fear has gone there will be nothing.
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

> Only I will remain.

It worked, I kept myself calm and the tooth came out with a slight twinge.

I am not saying that childbirth for me was just

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

Professional from academic institutions, pharmaceutical industries, health care indust

a twinge, I had a quick labour but there wasn’t much time for me to collect myself between contractions. It did hurt, and at times it was nasty but it

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

asn’t a terrifying pain. It felt hugely productive and as soon as the baby was out, all sensations other than overwhelming love and bewilderment were fo

.

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

gotten. And I’m not good with pain, I cry if I bump my elbow, get stung or trip up. I am self-confessed wuss! But I trusted in myself and in the amazing

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

Companies that provide selfless information through particip

resources and stamina a woman giving birth can have. It was a beautiful birth, an amazing thing to do and it turns out I'm not scared of the baby either

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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