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To cull or not to cull? I am of the opinion that in an Island reserve such as Pilansberg or Madikwe, if you cannot translocat

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

e the excess Elephant there is no other alternative but to cull in order to maintain the ecological integrity of the Reserve

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

Examples of combination products may in

However this is not the case with the Kruger National Park Elephant situation.
I, after spending many years l

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

ving in Timbavati side by side with Elephants and interacting with them on a daily basis, have formed a different view.

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

National Parks and Reserves should be audited to ascertain whether the Reserve in question could sustain a Elephant populat

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

Combination pro

on crash and if so, Elephant populations should be allowed to climb and crash as the natural cycles dictate.The natural r

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

ythms of Nature have evolved over millions of years and mans imperfect judgements have not a patch on that kind of intellige

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

ce.

The Kruger National Park has recently become a Transfrontier Park.An additional Million hectares has now been fen

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

ed in with the KNP.The KNP is now three million Ha in extent.Larger than than Wales or Israel!

This res

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

rve could possibly sustain Elephant populations indefinitely as occurs with Wildebeest populations in the Serengeti.

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

There needs to be a paradigm shift in the thinking of Conservationists who support culling and consider it the only the altern

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

Following aspects would a

ative.Nature has looked after its self for millions of years, Conservation is a new science and has only been practised as "educ

dd to the challenges in developing combination products:

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

ted guesses" for about 80 years or so.

We need to comprehend that culling is only one option of many and each

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

ituation is unique.To cull at this time while the park is expanding is premature.KNP Management is still trying to push Elephant

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

into new areas - if they are doing this it only goes to proves that there is still plenty of space. Elephants have an in-bui

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

t genetic Intelligence that will ultimately come to the fore if allowed.

If we cull we will miss the opportunity

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

Professional from academic institutions, pharmaceutical industries, health care indust

o witness and learn from that.

The Elephants and other wild life are stimulus- response organisms and will responded to

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

any stimulus in their environment.
Culling will lead to more prolific breeding.Over population will lead to some Elephants

.

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

oving into new areas without having to be forced.
Allow them to do their thing and I sure we will learn a thing or two and

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

Companies that provide selfless information through particip

e pleasantly surprised.

My vote goes to applying a flexible, accountable approach to the situation.Viva the Elephants

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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