presentation_dimendra_mar 30,2011
TRANSCRIPT
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Dimendra patelBaroda college of pharmacy
Mar 30, 2011
CONCEPTS & APPLICATION
FOR REGULATORY
SUBMISSIONS TO
REGULATED MARKETS
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INVESTIGATIONAL NEW DRUGS (IND)
NEW DRUG APPLICATION (NDA)
ABBREVIATED NEW DRUG APPLICATION
(ANDA)
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NDA & IND
NDA (New Drug Application) : Cost Benefit Analysis :
Safety vs Risk
Package Insert Appropriateness GMP & Controls - ISPQ
IND (Investigational New Drugs) :
First Step for NDA
Establishes safety for test on Humans
Investigator Initiated & Sponsor Initiated
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NDA
Phase I :
Healthy Volunteers
Acute Toxicity
Phase II : Dose Determination
Phase III : Double Blind Placebo Controlled Trials
Phase IV : Post Approval Trials
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COMPARATIVECOMPARATIVE
Brand Name Drug Generic Drug
NDA Requirements ANDA Requirements
1. Chemistry 1. Chemistry
2. Manufacturing 2. Manufacturing
3. Controls 3. Controls4. Labeling 4. Labeling
5. Testing 5. Testing
6. Animal Studies
7. Clinical Studies 6. Bioequivalence
8. Bioavailability
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WHY ANDA??:
To decrease the price of drug
To decrease the time of development
Increase the bioavailability of the drug in comparison
to reference list drugs.
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Critical Factors for Understanding
Guidelines
ICH (International Conference Harmonization)
GMP (CDER Centre of Drug Evaluation Research)
RLD (Reference Listed Drug) / Innovator
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NEW PRODUCT CUSTOMER
REGULATIONSNEED PRICE
Satisfaction of
Need Affordability
Claim Quality &
Stability
Technology / Process
EffectivenessAssurance
(cGMP & Systems)EHS
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WHY NEW PRODUCT ??????WHY NEW PRODUCT ??????
Supply / Demand Gap
Shortage
Demand Potential
Distribution Limitation
Manufacturing Feasibility (Technology Transfer)
Facility
Location
Innovation
Substitutes
New Application
NCE / NBE
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PREPRE--INVESTMENT REVIEWINVESTMENT REVIEW
i SWOT of New Products
i Market Survey
Niche Identification Product Positioning
Target Market Share
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PREPRE--INVESTMENT REVIEWINVESTMENT REVIEW
(contd.)(contd.)
Pre-Launch
Launch
Promotion
Budgeting
Contribution
Analysis
Capital Costs
Human Resource
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NEW PRODUCT MANAGEMENTNEW PRODUCT MANAGEMENT
PHASESPHASES
Screening of Product
Product Development
Formulation Development
Packaging Development
Stability Studies & Analytical Development
Regulatory Approvals
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NEW PRODUCT MANAGEMENTNEW PRODUCT MANAGEMENT
PHASESPHASES (Contd.)(Contd.)
Line Decisions
Marketing Mix
Product Promotion
Distribution Price
Test Marketing
Product Launch
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NEW PRODUCT MANAGEMENTNEW PRODUCT MANAGEMENT
PHASESPHASES (Contd.)(Contd.)
Monitoring Market Share
Monitoring Competitors Strategies
ME Too Competitors
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Review of Market Share & Strategies
Changes in Marketing Mix
Extension of Product Line
Backward Integration
Forward Integration
POST LAUNCH STAGESPOST LAUNCH STAGES
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PRODUCT LIFE CYCLEPRODUCT LIFE CYCLE
Growth
Stagnancy
Decline
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Communication & Training
Customer
Intra - Organization
Human Management
Sales Force
Market Research
R & D
IMPORTANT ELEMENTS OFIMPORTANT ELEMENTS OF
PRODUCT MANAGEMENTPRODUCT MANAGEMENT
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THE SUCCESS ELEMENTSTHE SUCCESS ELEMENTS
Vision & Entrepreneurship
Resources
Generation
Optimization
Operational Management
Systems & Sub - Systems
Succession Plans
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WINNERS ARE
Pro- Active Minds
Fast & Agile Workers
Leaders
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