Delicious - Home and Family

Pregnancy week by week brings new development in woman’s body. Pregnancy period of 40 weeks can be divided into 3 tri

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

mester (which means three months long). First trimester includes the period from week 1 to week 12. Second trimester

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

Examples of combination products may in

s from week 13 to week 26 while third trimester commences at week 27 and continues to term (which is the 40th week).

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

Week 1 to week 12

In this trimester of pregnancy week by week child grows rapidly and forms all organs and bo

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

y structures, though very tiny. To put things into perspective - the baby is tinier than a grain of rice!!! Week 4 ma

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

Combination pro

kes the woman realize that she is pregnant. Within a week, heart of the baby starts beating.

Week 13 to Week 26
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
>

Thirteenth week onwards, pregnancy enters into the second trimester and there are further developments in pregnanc
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
week by week. Baby further develops and gradually, vocal chords begin to form, the nervous system starts to function
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
and the reproductive organs become fully developed. Baby’s hair, eyelids, eyebrows, eyelashes, nails, fingers and toe
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
s also get formed. This is a period where one can see on ultrasound whether it is a boy or a girl. By week 20 one can
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
feel the baby moving. Within next 3-4 weeks baby’s skin is reddish in color, wrinkled with veins visible through baby
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
s translucent skin. This is also the period when the baby may start responding to sounds.

Week 26 to Week 40
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
This is the trimester during which pregnancy week by week enters into its culminating stage. During this period the f
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
at starts depositing on the baby. His/Her hearing is fully developed and can move with the rhythm to music. By week 2
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
babies can even cry. By Week 29 of pregnancy the senses of sound, smell and taste are also developed. Week 32 is the
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
time when baby spends most of its time in sleeping. Lungs are almost fully developed, baby can open and close the eye
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
and can also grasp firmly. During these weeks the baby position changes to prepare itself for delivery. The baby dro
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ps down in the pelvis with its head facing down towards the birth canal.

As one shall realise by now, pregnancy is b
.

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
far the most sophisticated process in the human body. Pregnancy week by week undergoes marvelous changes – changes w
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ich have till date left even the most scientifically equipped human amazed at this intricate accomplishment of nature

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Delicious - Your Friendly Guide to Pregnancy Week by Week

Related Articles: