Nemera
Key insights for a successful device development to achieve bioequivalence requirements - Video
The most common use of multi-dose nasal sprays is for allergy-related symptoms, such as allergic rhinitis. This market is dominated by nasal preparations for the administration of locally acting drugs such as steroids, where the delivery system is a critical element for therapeutic efficacy.
Moreover, the majority of big pharmaceutical drugs came or are coming off patent. We observe new trends for regulatory strategy and commercialization of nasal sprays:
1. Generic companies inquire for an equivalent delivery system to the Reference Listed Drug,
2. Innovator companies switch to Over-The-Counter status to protect from market erosion due to generics.
Speakers will cover several subjects related to the nasal spray development from different perspectives.
A detailed review of the device influence in terms of nasal spray characteristics and performances will be presented.
The bioequivalence requirements, as well as region-specific regulatory strategies, will be discussed.
Also, we will demonstrate how fundamental the control of the testing methods and statistical computation are to ensure reliable bioequivalence assessment.
Recognized as a world leader in design development and manufacturing, Nemera will provide useful advice for a successful development with respect to bioequivalence requirements.
Presented by
Pascale Farjas - Global Category Manager
Alain Regard - Technology Product Manager
Céline Petitcolas - Customer Technical Support
Moreover, the majority of big pharmaceutical drugs came or are coming off patent. We observe new trends for regulatory strategy and commercialization of nasal sprays:
1. Generic companies inquire for an equivalent delivery system to the Reference Listed Drug,
2. Innovator companies switch to Over-The-Counter status to protect from market erosion due to generics.
Speakers will cover several subjects related to the nasal spray development from different perspectives.
A detailed review of the device influence in terms of nasal spray characteristics and performances will be presented.
The bioequivalence requirements, as well as region-specific regulatory strategies, will be discussed.
Also, we will demonstrate how fundamental the control of the testing methods and statistical computation are to ensure reliable bioequivalence assessment.
Recognized as a world leader in design development and manufacturing, Nemera will provide useful advice for a successful development with respect to bioequivalence requirements.
Presented by
Pascale Farjas - Global Category Manager
Alain Regard - Technology Product Manager
Céline Petitcolas - Customer Technical Support
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