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Hot dry summer weather brings about heat and drought stress on summer annuals. Stressed plants such as the forage sorghums can occasionally

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

accumulate dangerous concentrations of nitrates. These high nitrate plants, either standing in the field, or fed as hay, can cause abortio

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

Examples of combination products may in

n in pregnant cattle, or death if consumed in great enough quantities. Nitrates do not dissipate from suncured hay (in contrast to prussic

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

cid), therefore once the hay is cut the nitrate levels remain constant. Therefore, producers should test summer annual hay fields before th

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

ey cut them for hay. Stop by any County Extension office for testing details. Testing before cutting gives producers an additional option o

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

Combination pro

f waiting and allowing for the nitrate to lower in concentration before harvesting the hay. The major sources of nitrate toxicity in the So

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

th and Southwest will be summer annual sorghum type plants, including sudan hybrids, sorgo-sudans, sorghum-sudans, millets, and Johnsongras

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

s.

Some of the management techniques to reduce the risk of nitrate toxicity (Note: the risk of this poisoning cannot be totally eliminated

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

), include:

Test the crop before you harvest it. If it has an elevated concentration of nitrates, you still have the option of waiting for

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

normal plant metabolism to bring the concentration back to a safe level. And experience tells us that we cannot estimate nitrate content ju

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

st by looking at the field.

Raise the cutter bar when harvesting the hay. Nitrates are in greatest concentration in the lower stem. Raisin

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

Following aspects would a

g the cutter bar may reduce the tonnage, but cutting more tons of a toxic material has no particular value.

Cut in the afternoon or early

dd to the challenges in developing combination products:

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

vening hours. Some research has indicated that nitrate accumulation increases during the night time when photosynthesis is not occurring. A

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

fter several hours of daylight, the plant begins to grow and utilize the nitrates for protein synthesis.

Know the extent of nitrate accumu

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

lation in the hay. If you still have doubt about the quality of the hay, send a forage sample to a reputable laboratory for analysis to get

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

an estimate of the nitrate concentration. This will give you some guidelines as to the extent of dilution that may be necessary to more saf

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

Professional from academic institutions, pharmaceutical industries, health care indust

ely feed the hay.

Allow cattle to become adapted to nitrate in the hay by feeding small amounts of the forage along with other feeds such

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

as grass hay or grains, cattle begin to adapt to the nitrates in the feed and develop a capability to digest the nitrate with less danger.

.

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

roducers should avoid the temptation of feeding the high nitrate forage for the first time after a snow or ice storm. Cattle will be stress

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

Companies that provide selfless information through particip

ed, hungry, and unadapted to the nitrates. They will consume unusually large amounts of the forage and be in high risk for nitrate toxicity

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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