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    Trauma, stress and memory

    The word 'trauma' originates from the Greek 'wound', and it refers to both psychological and physiological aspects. Trauma occurs as a result of a serious event and it has deep roots in various levels of the human mind and behaviour.

    What causes trauma? Psychological trauma is a broad concept, and its origins are co-related with two well-kn
    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
    own mechanisms of the human mind: stress and memory.

    Albeit commonly associated with negativeness, stress is an evolutionary advantage. The stress triggering mechanism allows most people to react to dangerous situations prior to consciously detecting it - also known as 'fight or flight' response. The level of a stress response generally dictates the intensity of psychologic
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    al trauma in an individual.

    Memory and trauma are interrelated processes - without the memory of a traumatic event, psychological trauma is non-existent. In addition, memory also plays an active role in the incidence and intensity of stressful responses. Once stress is triggered by an event (a stressor), several processes instigate the assessment of the situation by higher
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    functions of the mind (prefrontal cortex - responsible for decision-making).

    If the situation does not constitute danger, the stressing mechanism will gradually shut down and the body will return to normal functioning. If the situation reflects danger, the individual will need to decide what to do - and in that process - the amygdala (a part of the limbic system which plays
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    a key role in human emotions, particularly fear) directs the hippocampus (a central region of human memory) to imprint that information differently from other events. This long-term storage of the memory is explained by its emotionally-attached significance.

    Such a mechanism is another 'smart' human feature. Next time the same stressor (or similar) is identified, that memo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ry will be instantly retrieved in order to assist in the individual's reaction. At a subconscious level, there will be an overstressed response to the event. At a conscious level, comparison and previous experience will induce better decision making.

    Trauma and Health

    Trauma is inevitable in our lives. From the birth of a child, to all stages of its development - tr
    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
    aumatic events are common and also part of the 'human experience'. However, the level of trauma caused by an event dictates the short and long-term effects of that occurrence.

    For instance, trauma can be related to several mental illnesses. Conditions such as Schizophrenia, Depression, and Bipolar Disease can be triggered by traumatic events. One condition in particular, 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
    directly related to trauma and very common in the counselling context: Post Traumatic Stress Disorder (PSTD).

    Post Traumatic Stress Disorder (PSTD) occurs when an individual develops a set of behaviours and reactions based on a traumatic event. The traumatic experience interferes with normal functioning, causing the affected person to present avoidance behaviour.

    This cond
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ition can occur at any age and traumatic stress can be cumulative over a lifetime. Responses to trauma include feelings of intense fear, helplessness, and/or horror. This condition has roots in the relationship between stress, trauma and memory.

    It is perceived that PTSDs are originated from a 'defect' in the brain's memory processing functions. As previously described, emo
    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
    tionally attached events are stored differently (at a 'deeper' level). These memories include stressful and traumatic events, particularly those which resulted in some kind of harm and emotional distress to the person.

    Upon the identification of the same stressor (or similar) that caused a reaction for the previous situation, the body would instantly trigger an overstressed
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    response. However, in most cases, the new event will not constitute a threat. For instance, a noise could be a stressor from a situation in which a person ended up being assaulted. The same noise, or something similar, could occur in other situations which are harmless. Unless that stressor is reinforced (results in danger over time), your brain will adapt to the stimulus a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nd gradually reduce the stressful response. This process is called 'extinction' (Pavlov's Theory).

    If extinction fails to take place, the individual will continue to react (stressfully) to the original stimulus, or similar ones. This is the case for PTSD sufferers. Because the human body is not prepared to maintain stressful status continually, side effects will appear. The
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    se effects are both physiological (Coronary Heart Disease, ageing acceleration, etc) and psychological (fear, avoidance, etc).

    This explains the occurrence of PTSD in war veterans who were exposed to stress over a long period of time and accident survivors who have been exposed to a highly stressful and traumatic situation.

    Trauma and Counselling

    The effects of tra
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    uma may vary greatly among people. The extent, frequency and intensity of each event are presented according to each person's mindset and previous experiences. And because traumatic events are cumulative over life, it can be quite difficult to provide a treatment that comprises all problems derived from separate traumas.

    Most people adapt to trauma in their lives, and throu
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    h the extinction process, do not experience much psychological harm derived from past events. However, for patients with PTSD, and other stress-triggered conditions, the situation requires further attention.

    Currently, counsellors use three major treatments to combat PTSD. These treatments are largely based in psychotherapy, introspection and conditioning:

    Cognitive Beh
    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
    aviour Therapy (CBT) is a form of psychotherapy that focuses on modifying an individual's behaviour by changing their thinking. Therapists believe that by focusing in the individual's perspective, it is possible to bring about behaviour change, and therefore, cope with the trauma. This form of treatment is recommended by the World Health Organisation and it is widely use
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d to combat PTSD symptoms.

    Debriefing is single section-based treatment which occurs shortly after the traumatic event. The debriefing process evolves on the 'traumatised' individual's verbal expression of the event. It is suggested that by 'letting out' those memories and feelings, the person is more unlikely develop suppressed emotions, which reduces the effects of
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    trauma. Debriefing is widely used for professionals that deal with traumatic events on a daily basis (e.g. paramedics).

    Eye Movement Desensitisation and Reprocessing is a technique based on a psychophysiological approach. According to the theory, the overload of emotions derived from traumatic events interferes with the individual's information processing episode. T
    .

    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
    hat interference, at a physiological level, produces 'flawed' pathways of memory retrieval, which in turn, results in the non-logical perception of the event. For instance, a victim of rape, albeit aware that the fault was of the perpetrator, continually invokes self-blame for the incident. The process of desensitisation and reprocessing would serve to reprogram those pathwa
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ys, resulting in the extinction or partial extinction of negative symptoms.

    © Australian Institute of Professional Counsellors.

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    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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