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Pharmaceutical Manufacturing and Packing Sourcer
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Medical packaging must comply with an increasingly complex set of requirements imposed by both regulation and the demands of product managers. Often, ease of use requirements are either ignored or seen as being at odds with other, more critical requirements, such as the requirements for child resistant packaging. An ageing population has caused renewed interest in designing medical packaging that is more ‘elderlyfriendly’ and generally easier to use. Human performance research has contributed greatly to knowledge bases and has led to a better understanding of how to meet the medical packaging needs of older adults, but many gaps remain. A user-centred approach during the design and optimisation of packaging solutions can lead to an engineered result that meets packaging requirements and the needs of consumers (1).
Medical packaging that is too difficult to open is a common source of consumer dissatisfaction (2). The demand for ease of use in medical packaging is expected to increase as the population ages. Agerelated functional decline in strength, dexterity, and visual ability directly impacts packaging ease of use (3-5). With an ageing population comes an increase in the prevalence of arthritis, which is the number one cause of disability in the US (6). The need for easy to use packaging for medical products designed to treat arthritis is clear. Consumers seeking relief from the symptoms of arthritis should not have to suffer while accessing their medication. Additionally, arthritis is a common comorbidity with other chronic diseases such as diabetes and heart disease, suggesting a compelling reason for addressing ease of use issues in all medical packaging (7).
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Sphere Fluidics expands into additional facility at Granta Park in Cambridge, UK
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Key to Outsourcing Method Development and Validation: A Pragmatic Approach
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In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation.
As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP).
Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
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