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L13 Recent trends in pharmacoeconomics: Needs and unmet needs
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e u r o p e a n j o u r n a l o f p h a r m a c e u t i c a l s c i e n c e s 3 4 S ( 2 0 0 8 ) S7–S24
ness, but it also gives information about the sample shape. Photoacoustics combines light and sound. Photoacoustics evaluates film coating properties. A YAG laser pulse (duration) generates acoustic waves in the film coating. Propagating Rayleigh surface waves are affected by the film properties. The surface wave is non-destructively and non-contactingly detected with, e.g. a laser Doppler vibrometer. An ultrasonic pitch-catch method with broadband piezoelectric transducers embracing the sample estimates the drug granule size distribution. The spectrum of a broadband wave propagating through the interstitial air between the granules (fluid mode) or through the force chains formed by them (solid mode) is affected by the granule shape and size as well as by the mechanical properties of granules in case of the solid mode propagation. A miniscule mark left by the photoacoustic excitation in the coating serves as a ‘tested’ seal. Physics based process control provides narrower tolerances, and individually tested products realizing the concept of designing quality into the process. Improved understanding of the manufacturing process increase its yield and effectiveness saving raw materials. doi:10.1016/j.ejps.2008.02.026 L12 Particle size determination during fluid bed granulation— Challenges and opportunities
CORE COMPETENCES IN PHARMACOECONOMICS L13 Recent trends in pharmacoeconomics: Needs and unmet needs Alan Lyles University of Baltimore, USA Pharmacoeconomics arose to meet decision-makers needs: in industry, deciding among specific research and development alternatives; in government, determining program benefits and prices paid; in the private sector, designing insurance benefit coverage. Some still see it as “pharmacoaccounting”—tallying prices, but stopping short of actual economic considerations. Yet, it is maturing methodologically as a discipline and in practice as an applied decision-making tool, but wide disparities in views continue: what it is, how to interpret it and how to use the analytic results. The main challenges for pharmacoeconomics continue to be: (1) establishing guidelines or standards of practice, (2) creating a cadre of trained producers and consumers of pharmacoeconomic work, (3) continuing education on the relevant features of this discipline for practitioners, government officials, private sector executives and (4) stable funding to support applied pharmacoeconomic research. This session examines the main needs and unmet needs of this evolving applied discipline.
¨ anen ¨ Tero Narv Orion Pharma, Espoo, Finland Fluid bed granulation (FBG) is widely used in pharmaceutical industry. FBG is a good example of a multivariate process where effective and reliable process control tools are important to ensure end product quality. Traditional process measurements, such as temperature, relative humidity, pressure difference and air flow rate can be monitored during the process, and the critical process parameters can be identified. Although, process analytical technology (PAT) tools have been developed and applied in FBG environment, the determination of particle size distribution during the granulation is still challenging. The starting materials can be sticky by nature, and the moisture level of the mass can be high during the spraying phase. Consequently, monitoring of the particle size is not straightforward, because windows and in-line probes are prone to coating during the granulation. Due to the challenges related to in-line particle size measurement in FBG, on-line and at-line techniques have also been developed and applied. We have studied the particle size determination during granulation in a bench-scale FBG (Glatt WSG5), using in-line, on-line and at-line measurement techniques. In this presentation, the scientific findings of these studies will be summarised and some practical examples will be shown. Additionally, a novel on-line sampler and a 3D image analysis method for particle size determination during FBG will be presented. doi:10.1016/j.ejps.2008.02.027
doi:10.1016/j.ejps.2008.02.028 L14 Cost-effectiveness making
in
Swedish
reimbursement
decision
¨ Andreas Engstrom LFN Pharmaceutical Benefits Board, Sweden In Sweden, the Pharmaceutical Benefits Board (LFN) is responsible for reimbursement decisions for all new pharmaceuticals. The LFN also conducts reviews of entire pharmaceutical groups. Decisions are to be based on national prioritization guidelines, where societal cost-effectiveness is a key decision parameter. Cost-effectiveness is also weighed against other criteria such as disease severity. No formal threshold value exists for a QALY but there is a higher willingness to pay for more severe conditions. An overview of how health economic analyses are used in the decision making process and how cost-effectiveness is balanced against the other criteria will be presented. doi:10.1016/j.ejps.2008.02.029 TUESDAY, JUNE 10 MODIFICATION OF l-DOPA AND DOPAMINE METABOLISM AS A BASIS OF DRUG THERAPY OF PARKINSON’S DISEASE: KEY FINDINGS DURING THE LAST 20 YEARS
e u r o p e a n j o u r n a l o f p h a r m a c e u t i c a l s c i e n c e s 3 4 S ( 2 0 0 8 ) S7–S24
ness, but it also gives information about the sample shape. Photoacoustics combines light and sound. Photoacoustics evaluates film coating properties. A YAG laser pulse (duration) generates acoustic waves in the film coating. Propagating Rayleigh surface waves are affected by the film properties. The surface wave is non-destructively and non-contactingly detected with, e.g. a laser Doppler vibrometer. An ultrasonic pitch-catch method with broadband piezoelectric transducers embracing the sample estimates the drug granule size distribution. The spectrum of a broadband wave propagating through the interstitial air between the granules (fluid mode) or through the force chains formed by them (solid mode) is affected by the granule shape and size as well as by the mechanical properties of granules in case of the solid mode propagation. A miniscule mark left by the photoacoustic excitation in the coating serves as a ‘tested’ seal. Physics based process control provides narrower tolerances, and individually tested products realizing the concept of designing quality into the process. Improved understanding of the manufacturing process increase its yield and effectiveness saving raw materials. doi:10.1016/j.ejps.2008.02.026 L12 Particle size determination during fluid bed granulation— Challenges and opportunities
CORE COMPETENCES IN PHARMACOECONOMICS L13 Recent trends in pharmacoeconomics: Needs and unmet needs Alan Lyles University of Baltimore, USA Pharmacoeconomics arose to meet decision-makers needs: in industry, deciding among specific research and development alternatives; in government, determining program benefits and prices paid; in the private sector, designing insurance benefit coverage. Some still see it as “pharmacoaccounting”—tallying prices, but stopping short of actual economic considerations. Yet, it is maturing methodologically as a discipline and in practice as an applied decision-making tool, but wide disparities in views continue: what it is, how to interpret it and how to use the analytic results. The main challenges for pharmacoeconomics continue to be: (1) establishing guidelines or standards of practice, (2) creating a cadre of trained producers and consumers of pharmacoeconomic work, (3) continuing education on the relevant features of this discipline for practitioners, government officials, private sector executives and (4) stable funding to support applied pharmacoeconomic research. This session examines the main needs and unmet needs of this evolving applied discipline.
¨ anen ¨ Tero Narv Orion Pharma, Espoo, Finland Fluid bed granulation (FBG) is widely used in pharmaceutical industry. FBG is a good example of a multivariate process where effective and reliable process control tools are important to ensure end product quality. Traditional process measurements, such as temperature, relative humidity, pressure difference and air flow rate can be monitored during the process, and the critical process parameters can be identified. Although, process analytical technology (PAT) tools have been developed and applied in FBG environment, the determination of particle size distribution during the granulation is still challenging. The starting materials can be sticky by nature, and the moisture level of the mass can be high during the spraying phase. Consequently, monitoring of the particle size is not straightforward, because windows and in-line probes are prone to coating during the granulation. Due to the challenges related to in-line particle size measurement in FBG, on-line and at-line techniques have also been developed and applied. We have studied the particle size determination during granulation in a bench-scale FBG (Glatt WSG5), using in-line, on-line and at-line measurement techniques. In this presentation, the scientific findings of these studies will be summarised and some practical examples will be shown. Additionally, a novel on-line sampler and a 3D image analysis method for particle size determination during FBG will be presented. doi:10.1016/j.ejps.2008.02.027
doi:10.1016/j.ejps.2008.02.028 L14 Cost-effectiveness making
in
Swedish
reimbursement
decision
¨ Andreas Engstrom LFN Pharmaceutical Benefits Board, Sweden In Sweden, the Pharmaceutical Benefits Board (LFN) is responsible for reimbursement decisions for all new pharmaceuticals. The LFN also conducts reviews of entire pharmaceutical groups. Decisions are to be based on national prioritization guidelines, where societal cost-effectiveness is a key decision parameter. Cost-effectiveness is also weighed against other criteria such as disease severity. No formal threshold value exists for a QALY but there is a higher willingness to pay for more severe conditions. An overview of how health economic analyses are used in the decision making process and how cost-effectiveness is balanced against the other criteria will be presented. doi:10.1016/j.ejps.2008.02.029 TUESDAY, JUNE 10 MODIFICATION OF l-DOPA AND DOPAMINE METABOLISM AS A BASIS OF DRUG THERAPY OF PARKINSON’S DISEASE: KEY FINDINGS DURING THE LAST 20 YEARS