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The location of the Pretoria Hilton is unique. On one side you have the interminable plains of the southern Savannah, on the other the majestic range of the Transvaal and all around it, the luscious

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

valley irrigated by the Olifants and the Krosolbal rivers. The hotel is indeed one of the finest in South Africa.The exquisite furnishings and appointments are matched by an excellent cuisine and imp

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

Examples of combination products may in

ccable service. Herr Aleck Van Michelsen runs a tight ship.

There was a knock at the door of my suite on the 25th floor. Without waiting for me to invite whoever was at the door to come in, the door

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

opened and in walked someone I did not expect to see:

"Jesus, Mandela" I exclaimed.

"No, no, Nelson. Nelson Mandela" he replied and laughed.

It had been a few years since Mandela and I had shared

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

a cell in a place that, I was sure, we were both trying to forget. I got up and we embraced, while his Biri Biri body guards stood outside by the door.

"What happened to your beard" he asked while h

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

Combination pro

looked at me with affection. I returned the look and asked:

"What happened to your black curls? You are as gray haired as Richard Gere!"

He proceeded to tell me about his problems with the various

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

coalitions, the new labor laws and the pressures from the white separatists. But he referred to them in a very objective way but not devoid of passion. At the end he said:

"I heard you were in Preto

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

ria and I knew I would have to come and see you in spite of the crazy schedule my people keep me under. I want you to come with me for lunch at the Pretoria Lawn Tennis and Country Club. You know, th

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

t club used to be a milk white facility. He sort of rubbed that one in. He knew I had been a member. What he did not know was that at the time I was madly in love with two of the member's wives, and

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

he club with its manicured forests, gentle hills and its discreet and inviting guest suites was a perfect place for illicit love affairs.

"I'll be delighted." I replied while I pulled out the miniat

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

re Phillips recorder from my attach? case and set it on the coffee table. He looked at it and with some resignation and observed:

"I see you still pushing a pencil. What happened to book number 6?"

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

Following aspects would a

He was referring to the book I worked on when I was in jail.

"Book number 6 came and went. You remember it was all about the situation in South Africa in the seventies. A French publisher picked it

dd to the challenges in developing combination products:

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

p and it did well, judging by the checks I get once in a while. But, I am not going to ask what you been up to. You Nobel prize winners are all the same. You run up to Stockholm, fill up with smorsga

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

bord and acquavit, get your medal pinned on your new suit, verify the numbers on the check and hightail it to warmer climates. "

He laughed and produced some Callard and Bowser Mint toffees from his

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

pocket. I took a couple and we toasted each other as we removed the familiar green wrapper. It had been a ritual in jail.

"You got to keep things in perspective" he observed in a sober tone.

"It t

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

ok the human race several million years to learn how to walk on two feet. And it has taken less than twenty years to recognize the rights that some people have in their own land. We are happy about o

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

Professional from academic institutions, pharmaceutical industries, health care indust

r accomplishments in South Africa "

I added: " Nelson, it is only the beginning. We all have much to learn still. Especially about tolerance. Incidentally, where did you get the mint toffees? I can

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

t seem to find them anywhere in Pretoria"

"Our Ambassador in London sends them by diplomatic pouch. I call it getting even for all those years without them! Now, let us go to the Club"

We took the

.

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

levator down to the lobby. His bodyguards led us to the front door of the hotel.

"Gee, this is a nice bus" I said. It was a 450 hp Mercedez Benz equipped in Italy with air conditioning, bar, lavator

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

Companies that provide selfless information through particip

es and reclining seats.

"Where do I sit" I asked Mandela.

He turned to one of his lieutenants and listened for an instant. Then he turned to me and said:

"This time you sit in the back of the bus!

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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