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  • Delicious - 3 Essential Things in Your Pregnancy

    When you are expecting baby, you need to take many critical decisions. Below are three things that you must think about during your pregnancy.

    1. Choosing the Right Healthcare Practitioner

    Depending
    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
    on health and type of pregnancy you have, you need to go to a family physician, an obstetrician, perinatologist, or a certified nurse-midwife.

    - Obstetrician/Gynecologist: These practitioners speciali
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ze in woman’s health; care during pregnancy; labor and baby’s delivery.

    - Perinatologist (Maternal-Fetal Medicine Specialist): They have a special training to handle high risked pregnancies.

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

    Physician: is an M.D., who has studied family practice medicine, which covers treatment of people of all ages and sex and hence can take care of a pregnant woman and deliver a baby.

    - Certified Nurse
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    -Midwife: Is a nurse and midwife with appropriate credentials in both areas. These practitioners can take care of pregnant women and are there during labor and delivery.

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

    Combination pro
    you choose to go for, it is equally crucial there is a positive doctor-patient relationship. Your doctor should welcome your queries and concerns giving you satisfactory and acceptable answers. Your re
    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
    lation with him/her should be honest, open, frank, and affable one.

    2. Routine Medical Check-Ups

    Receiving prenatal care soon after you get pregnant and its continuation throughout your pregnancy is
    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
    imperative to your and your baby’s health. You will possibly need one checkup every month during trimester. During the first visit, your doctor will take your thorough medical history and details of yo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ur lifestyle (e.g. if you smoke, drink or take any illegal drugs and so). This is to evaluate pregnancy risks, if any. Thus, you should give honest answers, even if they are embarrassing.

    You will hav
    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
    e a thorough physical examination including measurement of your height, weight, blood pressure; an internal pelvic examination; Pap smear for cervical cancer or infections.

    You will then be asked to g
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    o for certain medical tests, including Rh incompatibility test; blood tests to detect if there is any of these infection: hepatitis B, rubella, syphilis, and HIV; urine tests for detecting diabetes, in
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    fections; cervical culture for detecting any traces of sexually transmitted diseases (STD), e.g., Chlamydia and gonorrhea. If you are above 35 years, you will be asked to get a genetic screening test.
    dd to the challenges in developing combination products:

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

    Your doctor will discuss the type of diet and supplements you need to take, will talk about the substance you are to abstain from, which may be alcohol, tobacco and caffeine. He/she will also describe
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the importance of exercise to keep you fit during pregnancy.

    If all is well with your health and pregnancy, you need to see your practitioner only once a month during the first 28 weeks. During which
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    , your blood pressure and weight will be measured; your urine will be examined and you will be checked for any swelling or varicose veins.

    From 28th week to 36th week, you will be required to see 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
    practitioner once every 15-20 days,

    From 36th week until delivery, you need to go to your practitioner every week.

    It is to be noted that the above schedule may vary, depending on your doctor and if
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    you have any complications with your pregnancy.

    3. Monitoring Baby's Movements

    From second trimester onwards, you can feel your baby’s movements; an arm pushing or punching you, a leg that is passing
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    or kicking you. These movements are at the peak during 28th week, there after slow down because of increase in your baby’s size and there being limited space available for baby’s movements.

    Monitorin
    .

    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
    g baby’s movements is a good index of assessing baby’s well being. Sometimes, you may be asked to note down the number of movements felt per hour or doctor may do it himself using hospital facility. No
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rmally there are about 10 movements /hour. However, this number might vary from baby to baby. You need to concern if, all of a sudden, the number of movements greatly reduces than that you usually feel


    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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