UNIT 1 New drug discovery and development PRS(anuj sahu)
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Bpharmacy 8 semester pharmaceutical Regulatory science bp804T Unit I New Drug Discovery and development Stages of drug discovery, Drug development process, pre-cinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
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Regulatory Approval Process
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UNIT 2 Regulatory approval process and Regulatory authority and agency.pdf
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approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)
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Ocular Drug Delivery Systems NDDS.pptx
ODDS (Ocular Drug Delivery Systems) provide novel approaches for instilling drugs onto the eye's surface or inside the eye. Common ODDS include gels, ointments, microspheres, and nanoparticles, and they offer benefits like increased dosing accuracy, sustained drug release, and improved ocular bioavailability. However, they also present disadvantages such as inability to stop treatment during emergencies and potential interference with vision. The eye has multiple barriers that limit drug penetration, including the tear film, cornea, conjunctiva, sclera, and blood-retinal barrier. Physical methods like iontophoresis, sonophoresis, and microneedles can enhance drug transport across these barriers. A
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This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.
“Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
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Includes:
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Like Non-effervescent system, Effervescent system, Raft forming system,
High Density system, Expandable system, Muco-adhesive system,
Super porous hydrogel system and Magnetic Systems, etc.
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hatch-waxman act@amendments
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9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
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