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When traveling with children, you must Plan Before You Stand! When you dress your children for travel, remind yourself that they too need to wear clothes with little or no metal. Overalls will

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

alarm. Small children will be asked to remove their shoes, so have them wear slip on shoes.

If your child is traveling alone, parents are allowed to walk them to the gate with an escort pass

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

Examples of combination products may in

from the airlines. Just show your escort pass to the metal detector screener. Ask for a supervisor if the screener questions the pass.

Primary screening is hard enough for children, especiall

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

y if the screener requests the parents to divest the child’s security blanket or favorite stuffed animal. Children don’t understand why; all they know is that something they treasure and love

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

as been stripped away from their tiny hands, and now they are upset. By this time they are pitching a fit. They are in the middle of a breakdown. As the child throws a tantrum, the parent is t

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

Combination pro

ying to get him or her to walk through the metal detector. The child just stands there and cries. At this point they pick up their child and walk through together. They both alarm. They go bac

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

k and check to make sure that all of their metal items have been divested, and they walk through again. They alarm again. Now there is a bigger problem as they are both required to go to secon

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

ary screening, and the child is even more upset. The crying turns into screaming.

Remember the child started crying at the metal detector and now is in secondary screening. They both alarmed,

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

so the parent holding the child has to be screened too. You cannot pass the child off to the other parent until both child and parent have been cleared.

I have seen three things happen when a

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

child is screaming at the top of his or her lungs. One is that the parent and the child go into private screening, which enables the child to calm down in a private place. The second is that

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

he parent allows the child to scream while the screener performs secondary screening on the child. At this moment, the child usually starts to hit the screener. The third is the parent calms t

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

Following aspects would a

e child down first and screening begins. Ideally, private screening would be the perfect place for an over stimulated child to calm down. This is not the appropriate place for a timeout.

In e

dd to the challenges in developing combination products:

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

very case, the screener should clear the child first. Then the child can sit in his or her stroller and recover from such a dramatic experience while the parent is cleared. Some children don’t

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

have a problem with undergoing secondary screening, even if they don’t understand what’s going on. The reason is collaboration between the parents and the screener. A parent must be present in

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

order to conduct secondary screening on your child (under 18 years old). The parent will need to explain the process to their child, and if the child is too young, it is up to the parent to ea

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

se the child’s fear of the process.

Strollers, car seats, and baby carriers in any form must go through x-ray.

TIPS

■ An infant will either have his or her own boarding pass or there

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill be a stamp on one of the parent’s boarding passes. Check your tickets before leaving the ticket counter.

■ Carry your baby or small child through the metal detector to avoid stress.

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

■ Make sure your children are not placing their hands on or near any part of the x-ray belt to avoid injury.

■ Once you are through the metal detector, pick up your items and mov

.

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

e down. Leave room for others to come through too.

■ Place all carry-on items, including baby blankets, toys, and food, in a bin or bag.

■ When going through the maze (roped area

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

Companies that provide selfless information through particip

leading to the x-ray machine) keep your children close to you. This is for safety and security reasons.

■ Ask the airlines for an escort pass if your child (under 18) is traveling alone

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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