What is the primary objective of product life cycle management?
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To convert ideas into candidate drugs for development and candidate drugs into products for registration and sale.
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What is the primary objective of product life cycle management?
To convert ideas into candidate drugs for development and candidate drugs into products for registration and sale.
What is the primary strategy to achieve the longest possible market exclusivity?
Ensure the best patent protection.
What are some major hurdles to successful product registration and sale?
Novel compounds, unmet medical needs, safety, tolerable side effects, and robust clinical trial processes.
What can companies introduce to extend the life of a product and maintain revenue?
New indications, formulations, manufacturing processes, devices, and general technology that are patent protected.
What factors contribute to the lengthening of drug development?
Increase in preclinical phase duration, clinical and regulatory period for marketing approval.
What is a significant challenge facing the pharmaceutical industry regarding sales growth?
Increasing competition and threats to maintaining continued sales growth and income.
What is a significant risk associated with a minimum development programme?
High costs of retrospective fixes due to poor product/process design and potential product recalls.
What is causing the cost of drug discovery and development to escalate?
There are no easy targets left, and the cost of development and goods sold is increasing.
How can companies improve profitability in drug discovery?
By reducing the total time-frame from drug discovery to market.
What is the trend regarding the source of drugs?
A shift from low molecular weight chemicals to more complex macromolecules (biologicals).
What does the product life cycle refer to?
All phases in the life of a product from initial development through marketing until discontinuation.
What are sophisticated drug delivery systems developed to overcome?
Limitations of conventional forms of drug delivery, poor drug absorption, and patient non-compliance.
What is the goal of product lifecycle management (PLM)?
To maximize early growth, sustain peak sales during the patent period, and delay post-patent expiry decline.
How does electrophoresis improve drug delivery?
It allows for rapid and controlled drug absorption of peptides and proteins.
What challenges do pharmaceutical companies face in bringing new discoveries to market?
Increasing costs of drug discovery and development, and delays in product registration and launching.
What is the purpose of breath-actuated aerosols?
To coordinate drug delivery with the patient's inhalation for efficient lung delivery.
What is a key consideration in the drug development process?
Selectively screening and eliminating compounds earlier based on results from small-scale studies.
What are bioerodible polymers used for?
To administer drugs from a matrix that degrades over time without requiring retrieval.
What is the trend regarding documentation for regulatory submissions?
More comprehensive documentation is required to demonstrate compliance with cGMP & cGLP.
What is the pressure on companies regarding product submission?
To submit early and develop the product 'right first time'.
