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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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