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Lying, we all do it.

For those of you, giving a vigorous shake of the head right now or eyebrow lift or head tilt....YES, you too.

Think about it. We all come with guises that force us into deceitful positions of varying deg

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

rees. We lie about Santa, Easter Bunny, birds and bees, confidential information, trade secrets, people's appearances. If you have kids or nieces or nephews or just kindergarten friends, study their gestures as they tell littl

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

Examples of combination products may in

fibs. They tend to have obvious non verbal cues as to the lack of veracity. They may cover their mouth, look away from you, scratch various parts of their bodies. These movements tend to be pretty obvious to the adult and gen

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

erally we are on to them in a flash. What does the child do? He or she learns to stop lying? I do not think so. No your little angels learn to modify their body language so that you cannot detect when they are lying.

Of cours

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

most times the people closest to us know when we are not telling the truth, the quiver in our voice , the one blink too many, whatever it is. But what do we do when the liars are not people we grew up with all our lives? This

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

Combination pro

is when we need to acquire analysis skills that collect data on the potential liars’ body language and draw reasonable conclusions.

We call lying all sorts of names: fantasy, tact, comic relief, sensitivity, secrets, vows, k

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

ndness. These euphemisms serve to make our lies more convincing as they rationalize our untruths. But if you are not telling the truth, you are lying. Liars possess varying degrees of skills, and it should be understood our sk

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

ill in lying depends on purpose, conviction and amount of practice.

Skill Levels:

Level one: Fibbers,

Level two: Scammers,

Level three: Paths (Pathological Liars)

Here are some verbal and non-verbal signs to detect lying.

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

SPATIAL CHANGES:

Liars are generally uncomfortable facing those they lie to. Creating space between them and the victim makes lying easier. There may be different rationale for these. If you cant see clearly, you can not tel

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

l I am lying, you cant see my mouth as clearly, you cant see the other parts of the body that indicate I am lying or you feel guilty about doing something that hurts another.

HIDING

Hiding behind objects, desks, doorways, co

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

nters etc. this is quite similar to Spatial Changes but it is also the adult equivalent of blocking their mouth or hands behind the back.

SPEAKING NO EVIL

Direct mouth covering to lightly touching areas around the mouth, ste

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

Following aspects would a

pling on the lips etc see Bill's picture at the senate hearing to determine if he had sex with that woman.

FIDGETING

Nervous tapping, foot shaking, collar adjustments, lint picking, organizing items....this is mostly done by

dd to the challenges in developing combination products:

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

unskilled liars or Obsessive Compulsives who are quite innocent but annoying, or so Ive been told.

POSTURING

Crossing legs, tensing of shoulders. Many of us cross our legs and may tense up in speaking at difficult times. Ma

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

e sure that other cues are considered along with this.

AVOIDING - EYE CONTACT

Eye shifting and not looking directly at counterpart is a good indicator but the direction of the shift can be even more useful: Up-Right (Creatin

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

g a visual lie) Right (Creating auditory lie) Please note down right is recalling feelings, not lying. Down-Right (Kinesthetic)

SMILING Plastering a smile on faces, giggling Smiling with lips only eyes not smiling. I am a te

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

rible giggler when it comes to lying, but I also do it when I am nervous.

PACE CHANGE

Walking and speaking slower Walking and speaking faster.

DEVIATION FROM NORM

Any extreme changes in behavior could possibly a sign of ly

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing. (suddenly picking up a book when they normally detest reading, giving unusual gifts,etc.)

EMOTION SEQUENCE DELAY

Not displaying the appropriate emotional behavior when making statement, but a few seconds afterwards. Oft

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

n cutting the emotion short after it is displayed. " No it was funny, really"....smile....stop smiling.

DEFENSIVENESS

Displaying defensiveness behavior instead of offensive behavior, particularly when confronted.

SPEECH PAT

.

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

TERNS

Avoiding using direct statement or direct quotes. Answering with questions Using humor to deflect Giving far more detail than necessary

Okay my last tip, don't go accusing the first person you meet of lying cause they

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

Companies that provide selfless information through particip

ooked right while pulling lint of their jacket. No the best part of having insight into a liar's intent, is to build your dossier and define the appropriate strategy to follow. The next move is yours.

Submitted by Kathy Thoma

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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