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    1.1 INTRODUCTION TO THE STUDY

    Stress is a factor, which is present in every individual however a right dosage of stress is essential to help people to do better at their work. But unfortunately areas stress is determined both to personal and work. The expected problems due to excess stress are,

    a) In personal life


    1. Poor health


    2. Heart diseases


    3. Endocrine disorders


    4. Psycho ­ problem


    5. Nerve disorders
    b) In work life


    1. Poor Concentration


    2. More mistakes


    3. Flow at work


    4. Relatively poor interest


    5. Poor grasping capacity


    The above haws been clearly indicated in the finding too.

    • Extr
    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
    a work and work being delayed by others and for whose cause they are also getting delayed.
  • Family related problems


  • Excess work at home


  • Poor food practices


  • Excess noise


  • have been found to be stress additives to any individual.

    However the problems get worse at work as there issues make them commit more mistakes especially,

    • the fear of doing things right


    • constant pressure from the boss


    • the feeling of being supervised


    • Family problems.


    Which become a vicious circles of stress which has to maintained at a balance to argument the right work levels.

    1.1.1 ABOUT THE STUDY

    The spice of life or a loss of death, stress is always
    ; 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 us. Some stress is healthy and stimulated people to adapt to challenge. However, reposts the European foundation for the improvement of living and working condition Dublin occupational stress at rates, which indicate that it threatens to cripple modern society.

    Stress is a most widely spread single occupational health problem. It is the problem for almost all employee. This phenomenon is also increasing globally. It is affecting all countries occupational and categories of people at work. Its cost is rising to the individual to industry and to the society. It can no longer be considered as an occupational and personal problem to be remedied by treating the individual. Stress preventions must deal with root causes.

    As pointed out by Prof.Lennart Levi,
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    Dept of stress research the karolinska institute approximately one in four of the 150 million workers in the European Community work constantly to tight deadlines. The same no of workers is engaged is short repitive tasks more than one in every three workers has no chance of changing task of work methods, the same proportion is not able to influence their speed or rate of work. He also indicated that the workers have a high workload and how decision Latitude; frequently they have no social support from their colleagues. There factors when especially combined form major risk for work stress. For the employee work stress usually leads to absenteeism, low productivity and excessive health care expenses.

    Stress challenges the traditional categorization of work rela
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ted illness because it bridge physical, mental and social well being. The difficulty arises from the fact that every individual can tolerate a different level of stress. Factors beyond the domain of work place may also influence his or her ability to cope with work. Excessive stress will cause physical illness and psychological disorders. From chronic fatigue to depression, the steps along this path might include insomnia, anxiety, lumbago and rheumatic attack or tobacco and alcohol abuse. It can eliminate in heart attack, accidents and even suicides.

    Stress can feel to high rates of absenteeism, work force turnover or other forms of withdrawal from work, which can lead to high production cost, reduced competitiveness and human performance below its potential
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    So far as society is concerned, the effects are equally damaging. Impoverished personal and family life, low self esteem, low job satisfaction and a withdrawal form participation in communal life are some potential results.

    What is Stress?

    The term stress is derived form the Latin term “String ere” which means “to clutch compress or bind”. In the 15th century the term was used to describe troubles or pain. A century later, the term was used to describe burden force or pressure, especially on a person’s body or soul. In the 17th centuries, stress denoted ‘hardship’ pressure, strain or strong effort.

    Stress is a dynamic condition in which an individual is confronted with an opportunity, constraint or demand related to what he or she desires and for which the
    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
    outcome is perceived to both uncertain and important.

    Wolf and Goodell considered stress as inherent characterizes of life. They indicated that living creature is certainly in a state of more or less stress ­ a dynamic state within an organization stemming in response to a demand for constant. Adoption they further populated that different stress had divergent meanings for individuals in terms of their part experiences.

    A European foundation describes stress as a process. Stressors are present both at work and home. Stress is a person’s reaction to such factors and it can cause both acute and chronic diseases. Stress is a body’s reaction to stressors and also the way we experience it. Different people react differently stress is not entirely negative. Under
    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
    certain conditions it can be stimulating, helping people mobilize their resources to meet challenges.

    Measurement of stress

    Stress can be measured in various ways. Some researchers we the diary method, some we questionnaire and some we the technical method, where a subject is asked to estimate his or her stress level, on different sealer. Stress can also be measured in an individual’s blood or urine. Stress hormones reveal the nature of stress while blood pressure and pursue rate reflect the level of stress. Researchers can also obtain information from field studies of the actual working conditions at a work place.

    Different stress situations active different parts of an individual’s endocrine system. If the cortical level rises, It is a signal that an indi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    vidual is mobilizing resistance to stress. A blood sample provider information on stress levels at particular moment, where as urine sample are frequently used for monitoring the stress level during an entire working day.

    Blood pressure, pulse rate and the electrical signals from the brain can also use to measure stress levels. They reflect variations in stress instantaneously and efficiently.

    Gender and Stress

    Female workers report stress related symptoms more than men do. In some occupations women have a significantly risk of health problem due to psychological factors than men. These occupations relate to jobs in the manufacturing industry, postal assistants, telephone operators and cashiers, nurses and sewing women. Studies on women showed that social s
    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
    pport might have a negative effect on health. To women a large social network means obligations to other people and may functions at a stress increasing factor women are mentally active as men and their stress responses are less pronounced. Women react less to performance demands than men do. This is the reason women live longer, however, this gender differences is decreasing as men and women’s work roles become equal.

    Overtime has proved to have a more stressful effect on women. Even half-an hour’s overtime may be extremely stressful for a women because it intervened with her family obligations females ex are particularly stressed by their dual rate.

    Organisational factors

    There are no shortages of factors with in the organization that can cause str
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ess. Pressure to avoid errors complete tasks in a short duration a demanding and insensitive less and unpleasant coworkers are a few examples.

    We have categorized these factors around task, role and interpersonal demands Organizational structure; organizational leadership and the organizational life stage.

    Task demands

    Are factors related to a person’s job? They include the design of the individual’s job (autonomy, task, variety, degree of automation). Working conditions and the physical layout working in an over crowded room or in a visible location where interruption are continuous can increase anxiety of stress.

    Role demands Related to pressure placed on a person is a function of the particular role he or she plays in the organization. Role conflict crea
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ted expectations that may be hard to reconcise or satisfy. Role overload is experienced when the employee is expected to do more than time permits. Role ambiguity is created when role expectations are not clearly understood and the employee is not sure what he or she it to do.

    Interpersonal demands

    Are pressured created by other employees lack of social support from Colleagues and poor interpersonal relationship can cause considerable stress, especially among employees with a high social need.

    Organizational Structure

    Defined the level of differentiation in the organization the degree of rules and regulation and where decisions are made. Excessive rules and regulation and lack of participation in the decisions that affect an employee are examples of struct
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    re variables that might be potential sources of stress.

    Organisational Leadership

    Represents the managerial style of the organization senior’ executives some chief executive officers create a culture characterized by tension, fear and anxiety. They establish unrealistic pressure to perform in the short run; impose excessively tight control and relatively firing employees don’t “measure up”

    Individual factors the typical individual works about 40 to 50 hours a week. National survey consistently shows the people hold family and personal relationship dear. Marital difficulties due breaking of relationship and discipline troubles with children are examples of relationship problems that can create frees.

    Stress symptoms expressed on the job may actually originate i
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n the person personality.

    Individual differences

    There are five variables they are as follows:

    • perception


    • Job experience


    • Social support


    • Belief in local of control


    • hostility


    Employee reacts in response to their perception of reality rather than to reality itself. Perception there fore will moderate the relationship between the potential stress condition and the employee’s reaction to it.

    The evidence indicates that experience on the job tends to be negatively related to work stress. Why to explanations have been offered. First is the idea of selective withdrawal. Voluntary turnover is more probable among people who experience more stress. Second people eventually develop coping mech
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    nism to deal with stress. Because this takes time, senior member of the organisation are more likely to adopt and should experience less stress. there is increasing evidence that has social support is collegial relationship with co-worker or supervisor can buffer the impact of stress.

    Local of control is a personality attribute. Those with an internal local of control believe they control their own destiny. Those with an external local believe their lived are controlled by outside forces. Evidence indicates that internal perceive their jobs to be less stressful than do external.

    Some people personality includes a high degree of hostility and anger. These people are chronically suspicious and mistrustful of others.

    Consequences of Stress

    Stress shows itsel
    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
    f in a number of ways for instance an individual who is experiencing a high level of stress way develop high blood pressure, ulcer, irritability difficulty in making routine decisions and the like. These can be subsumed under three general categories physiological symptom, psychological symptom and behavioral symptom.

    Physiological symptoms Most of the early careers with stress was directed at physiological symptoms. Stress could create changes in metabolism, increase heart and breathing rates, increasing blood pressure brings head aches and induce heart attack.

    Psychological symptoms Stress can cause dissatisfaction. Job related stress could cause job satisfaction. It is “the simplest and most obvious psychological effect” of stress. But stress shows it s
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    lf in other psychological state-for instance tension, anxiety, boredom and procrastination.

    Behavioral symptoms It includes changes in productivity, absence and turnover as well as changes in eating habit, increase in smoking or consumption of alcohol, rapid speech and disorder.

    Managing Stress

    Individual Approaches An employee can take personal responsibility for reducing his as her stress level Individual strategic that have process effective include implementing time management techniques increasing physical exercise and relaxation training.

    Non competitive physical exercise such as aerobics, walking, jogging, swimming and bicycle have long been recommended by physicians as a way to deal with excessive stress level. These forms of physical exercise incre
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ase heart capacity provide a mental diversion from work pressure etc.

    Individuals can teach themselves to reduce tension through relaxation techniques such as meditation, biofeedback. The objective is to reach the relaxation where one feels physically relaxed and detached from body sensations.

    Expanding your social support network can be a means for tensions reductions it provides you to someone to hear your problems and to offer a more objective perspective on the situation. That is high support reduces the likelihood that heave work stress will result in job burnout.

    Organizational Approaches

    Several of the factors that can cause stress. Particularly talk and role demand and organizational structure are controlled by management. As such they can be modifie
    .

    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
    as changed. Strategic that the management might want to consider are.

    • Improved personal selection and job placement.


    • Use of realistic goal setting


    • Redesigning of job<


    • Increased employee involvement


    • Improve organizational communications


    • And establishment of corporate wellness program


    While certain jobs are more stressful than others we know for example that individual with little experience or an external leave of control tend to be more prove to stress. Selection and placement decisions should take these facts into consideration obviously management should not restrict hiring to only experienced individuals with an internal leave.

    Individuals perform b
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    etter when they have goal setting. They can do better when they have specific and challenging goals and receive feedback on how well they are progressing towards these goals. The use of goals can reduce stress.

    The Stress Audit

    In many organizations today, managers find that they must be more sensitive than in the past to potential sectors in their organizations, to maintain productive involved employee. They must recognize that employees may try to minimize stress even at the expense of promotions or significant pay increased. Managers and employees must be necessary for creative and productive work. We can evaluate the extent of dysfunctional stress in the situations by performing a stress audit, which helps to identify the symptoms and the cause of stress


    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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