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    Harriet*’s face had been etched into a mask of anxiety and pain by the years spent putting herself last while she tried to make bad relationships work. She came up to me o
    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 the last day of the course I’d been running on Domestic Violence Recovery to tell me how far she had come along her journey.

    She said she’d learned so much that she’d wi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    hed she’d known before. She also said that in recent years she had made better relationships. She’d been through domestic violence and wasn’t going there any more. Her l
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    test relationship, which had ended during my course, had not been abusive, but her partner had been ‘difficult’, the kind of man who pulls you down.

    He was, she said, alwa
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s negative, with no energy, someone who needed her to support him emotionally the whole time. She had found him a drain. He was someone who didn’t say or do very much. H
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    relied on her to lift his spirits and do all the caring. He didn’t lift a finger around the house, or even buy the occasional bottle of wine to ‘show willing’.

    But still,
    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
    she had been sad when it had ended because he was ‘a lovely person’; he was just a little depressed and depressing – her judgement not mine.

    Then, as she continued to thi
    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
    k about her lovely ex, Harriet’s face changed completely. She said, more to herself than me: “Actually, you know, he was abusive. It is abusive to pull your partner down
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nd contribute nothing to a relationship, but take, take, take.”

    She ran quickly through his behaviours and attitudes again registering his constant lack of respect and con
    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
    ideration of her feelings and re-evaluating her entire relationship.

    And then she said it: “Thank God he’s gone” - the very phrase that became my refrain after my own unl
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    vely partner’s departure.

    Harriet had started to see all the limitations that a depressive, inconsiderate partner imposed on her life – and all the opportunities and optio
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ns that lay before her without him there to blight them.

    It wasn’t that she envisaged a future of wild days and nights partying with beautiful people in exotic places.

    Wh
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t she saw was being able to return home after a day’s work, free to do exactly what she wanted. She saw the simple pleasures of being able to cook herself a meal - or not
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    chat to a friend, flop in front of the television, or soak in a hot tub without the constant need to worry about and lift another person’s mood.

    She saw herself actually
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    aving the space to put herself first for once – and even love herself first. Instead of last.

    She saw herself as blessed by his departure, rather than proved to be a fail
    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
    re as a woman and a partner.

    She saw it as the start of a new and rewarding period in her life – her relationship with herself – rather than the end of her last hope of ev
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    er being in a relationship.

    She saw it as the door slamming on a miserable past, rather than slamming on any hope of ever creating a worthwhile future.

    She saw that his p
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    esence, rather than his absence, diminished her.

    She saw that she had a far greater chance of dreaming, and achieving her dreams, without him than she had ever had with hi
    .

    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
    .

    And instead of bemoaning the failure of the relationship and her single status, she rejoiced in the promise of her future.

    “Thank God, he’s gone”. Thank God, Harriet c
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    n see that anyone who brings her down and disregards her feelings is abusive – and that life will be far, far richer without him.

    *not her real name

    (C) 2006 Annie Kaszin


    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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