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Certain responsibilities lie with the shipper for all LTL and TL shipments. These responsibilities apply across the board with all

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

freight carrier companies. Proper packaging, address labeling, shipment loading and unloading, and proper shipment documents (BOL

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

Examples of combination products may in

provided to you by us) are required by all carriers and are the responsibility of the shipper. These are things that your shipping

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

agent will assist you with, but you can get a good idea here of what to expect, along with some resourceful ideas on packaging an

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

other need-to-know info.

Packaging

Packaging, in most cases, will be the main protection (insurance) against shipment da

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

Combination pro

mage (unless factory new/factory packed). All the insurance in the world won't protect an improperly packaged shipment from damage

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

The main thing to remember is to use your best judgment when packaging an item for shipment. Delicate items should be packed on

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

a stable base and covered in a way to eliminate exposure to scratching or dinging. Crating, pallets, and heavy gauge cardboard sho

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

ld be considered for delicate items. Heavier, tougher items (like a cast iron stove, for example) wouldn't need to be packed so c

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

arefully, but mobility must still be kept in mind. Your best judgment applies to packaging all the many millions of items current

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

y being shipped across America.

Address Labeling

Proper address labeling is not that big of an issue; anyone who has ever

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

Following aspects would a

mailed anything through the US Postal Service knows how to properly label a shipment. It's as simple as where it is coming from an

dd to the challenges in developing combination products:

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

d where it is going to.

Shipment Loading and Unloading

Shipment loading and unloading is also the responsibility of the s

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

ipper. When using commercial or terminal locations with a loading dock, this is not an issue. But for residential pickup and/or de

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

livery this is a detail to be considered. In many cases you may want to plan on having friends, relatives, or neighbors on standby

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

to help with the loading and unloading. In some cases additional services such as lift gate may be required, but the additional co

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

Professional from academic institutions, pharmaceutical industries, health care indust

sts are to be considered. Always remember a "truck driver" does just what the title implies: drive the truck. The driver is never

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

esponsible for loading or unloading, although under reasonable circumstances he or she may help. It all goes back to using your be

.

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

st judgment.

Shipping Documents

Proper shipping documents, presented to the driver at the point of origin, are also the r

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

Companies that provide selfless information through particip

sponsibility of the shipper. These documents, along with simple instructions, will be made available to you by your shipping agent

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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