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  • Digg It - Double Enders using Skype and Audacity: Some Tips And A Few Things To Watch Out For

    Having done my first double ender I thought I would give out some hints and tips based on my experience.

    For those new to podcasting let me quickly explai
    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
    n that a double ender is where two people, at distance, use either a normal telephone or Skype to hold a conversation, but each records themselves locally
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    with a high quality mike. One person then sends the other their recording. The two voice tracks are then merged to give the effect of both parties being to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ether in a studio.

    Here are some things to be aware of.

    Use the same mike at both ends – or, at least, a mike that has the same sound characteristics. On
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    my first attempt, I made the mistake of having my remote guest use a Samson C01U USB condenser mike while I used a Shure SM58 at my end. They’re both grea
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mikes but they have very different sounds. When I merged the two recordings I sounded all warm, rich and sightly muted in an SM58 kind of way, while my co
    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
    lleague’s voice had the characteristic detailed top end, with clinically smooth midrange and bass characteristic of the Samson. While this was an interesti
    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
    ng acoustic experience it didn’t exactly give the impression that we where in the same studio.

    Understand that people converse differently when on the pho
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e. This is especially true when using Skype, because of the small delay you usually get. Try to remember to allow the other person to finish speaking befor
    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 you cut in – it’s very easy to speak over someone for several seconds without realising it when using Skype. This sounds terrible when you come to merge
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    he two voices. It’s better to allow your partner to speak at relative length, ensure they have finished, then come in with your, relatively long retort.

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

    Following aspects would a
    se the 1-2-3 clap trick to synchronise the two tracks. When both of you have fired up Audacity (or whatever you are using to record your voice), the first
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    thing you should do, in absolute synchronization, is shout out 3 times in succession, “one… two… three… “ [then clap]. Why. This will produce three very ch
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    racteristically shaped spiky waveforms on each recording – ideal for aligning the two tracks when you come to merge them. If you get these three spikes lin
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ed up, you know everything else is lined up too. It’s a bit like when film makers use the clapper board at the beginning of each scene to synchronise the s
    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
    und with the picture.

    Be prepared to spend time shortening pauses in post production. Because Skype has a slight delay, you may well notice longer than us
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ual pauses between speaking turns. Be prepared to shorten these to give the show a better pace.

    And finally, while you’re doing all this editing, be caref
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ul to include both tracks. When you are dealing with two or more tracks in Audacity, it is very easy to accidentally only highlight one when you meant to h
    .

    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
    ghlight two. Be careful, for example, when cutting a section out, that you do so from both tracks. If you cut it from only one, guess what, you’ve lost you
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r synchronisation – and that sucks!

    So, in summary, the double ender is a brilliant technique providing you keep your wits about you.

    Happy double ending


    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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