Regulatory Affairs
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Jul
6
sandeepsd
Janssen’s Fruitful Continuous Manufacturing Collaboration
Pharma News, Regulatory Affairs
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Jun
25
ragupathyrenganathan
Price regulation and relative delays in generic drug adoption
Regulatory Affairs
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Jun
16
sandeepsd
Formulation factors affecting acceptability of oral medicines in children – ScienceDirect
Formulation Discussion, Regulatory Affairs
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Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required to demonstrate acceptability of new paediatric formulations in target age groups as an integrated part of the development of these products (Kozarewicz, 2014). Two questions arise when trying to tackle this task: “which dosage form to choose for each target age group?” and “how to formulate it once the dosage form is decided?”. Read more …

Jun
16
sandeepsd
A science based approach to topical drug classification system (TCS) – Courtesy of Science Direct
Formulation Discussion, Regulatory Affairs
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The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in drug industry and regulatory approval has shown significant progress. This has been the case primarily because BCS was developed using sound scientific judgment. Following the success of BCS, we have considered the topical drug products for similar classification system based on sound scientific principles. Read more …

Jun
5
sandeepsd
Global Specialty Enzymes Industry 2015
Pharma News, Regulatory Affairs
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Jun
4
ragupathyrenganathan
Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
Formulation Discussion, Regulatory Affairs
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Jun
4
ragupathyrenganathan
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
Formulation Discussion, Regulatory Affairs
0
Jun
1
ragupathyrenganathan
Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
Regulatory Affairs
0
Jun
1
ragupathyrenganathan
Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
Regulatory Affairs
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Jun
1
ragupathyrenganathan
Do cost-sharing and entry deregulation curb pharmaceutical innovation?
Regulatory Affairs
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