MODULE 2: PRODUCT LIFE CYCLE AND PRODUCT LIFE CYCLE MANAGEMENT

Product Life Cycle

the length of time from a product first being introduced to consumers until it is removed from the market.

Product Life Cycle

are used by management and marketing professionals to help determine advertising schedules, price points , expansion to new product markets , packaging redesigns , and more.

Product Life Cycle Management

These strategic methods of supporting a product are known as product life cycle management.

Product Life Cycle Management

They can also help determine when newer products are ready to push older ones from the market.

1. Introduction

2. Growth

3. Maturity

4. Decline

4 stages of Product Life Cycle

1. Discovery/Development

2. Preclinical Research

3. Clinical Research

4. Data Review

5. Post-Market Monitoring/Life Cycle Management

Drug Discovery Process (5)

Introduction

This product life cycle stage involves developing a market strategy, usually through an investment in advertising and marketing to make consumers aware o f the product and its benefits.

Introduction

This stage usually involves the product development

Introduction

At this stage, sales tend to be slow as demand is created. Products can fail at this point, meaning that stage two is never reached. For this reason, many companies prefer to follow in the footsteps of an innovative pioneer, improving an existing product and releasing their own version.

Growth

At this point competitors may enter the market with their own versions of your product – either direct copies or with some improvements.

Growth

Branding becomes important to maintain your position in the marketplace as the consumer is given a choice to go elsewhere.

Growth

Product pricing and availability in the marketplace become important factors to continue driving sales in the face of increasing competition.

Maturity

Established in the marketplace. Cost of producing and marketing the existing product will decline.

Maturity

Beginning of market saturation

Maturity

Many consumers will now have bought the product and competitors will be established, meaning that branding, price and product differentiation becomes even more important to maintain a market share.

Maturity

Retailers will not seek to promote your product as they may have done in stage one, but will instead become stockists and order takers.

Decline

Eventually, as competition continues to rise, with other companies seeking to emulate your success with additional product features or lower prices, the life cycle will go into decline.

Market Saturation

Too many similar products are available.

Changing Customer Preferences

New technologies or trends replace old ones.

Intensifying Competition

Competitors offer more appealing alternatives.

● Product advertising

● Rebranding

● Price skimming

● Revamp the Product’s Features

● Target a New Market

● Create Product Variations or Extensions

● Promo

Product Life Cycle Strategy and Management (7)

R&D (Stage 1)

• Monopoly

• Idea → Promotion

Growth (Stage 2)

• Competition

• First Competitors

Maturity (Stage 3)

• Competition

• Competitors

• Innovating firm

• Mass production

Decline (Stage 4)

• Competition

• Obsolescence

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

● All serious adverse reactions

● All adverse reactions related to newly introduced medicines and vaccines

● Medication errors, lack of efficacy, overdose, and off-label use that resulted to serious adverse reaction

● Adverse reactions suspected to be related to a product defect

What to report? (4)

● Result in death

● Are life-threatening

● Hospitalization or prolonged hospital stay

● Involve a persistent disability or incapacity or congenital anomaly

● Other medically important event (require medical intervention to prevent any of the above outcomes)

5 Serious ADRs

1. evaluated

2. upgraded

3. renewed

4. cancelled

Based on Pharmacovigilance studies, the drugs should be 1. & can be 2., 3., or 4.

Drug Stability

Essential factor of quality, safety and efficacy of a drug product.

1. physical

2. chemical

Insufficient stability of a drug product can result in changes in ________ (like hardness, dissolution rate, phase separation, etc.) as well as in ________ characteristics (formation of high-risk decomposition substances).

1. more

2. less

Drug stability is biased towards ____ stressful rather than ____ stressful conditions.

○ Long-term & Accelerated

○ Stress Testing

Determine the shelf-life: (2)

Climate I
1. Temperate

2. 21 C

3. 45%

ICH Climatic Zones:

Climate I
1. Type of Climate?

2. Long Term Testing Temperature (C)

3. Long Term Testing Humidity (RH)
   

Climate II
1. Subtropical and Mediterranean

2. 25 C

3. 60%

ICH Climatic Zones:

Climate II
1. Type of Climate?

2. Long Term Testing Temperature (C)

3. Long Term Testing Humidity (RH)

Climate III
1. Hot and Dry

2. 30 C

3. 35%

ICH Climatic Zones:

Climate III
1. Type of Climate?

2. Long Term Testing Temperature (C)

3. Long Term Testing Humidity (RH)

Climate IVa
1. Hot and Humid

2. 30 C

3. 65%

ICH Climatic Zones:

Climate IVa
1. Type of Climate?

2. Long Term Testing Temperature (C)

3. Long Term Testing Humidity (RH)

Climate IVb
1. Hot and Very Humid

2. 30 C

3. 75%

ICH Climatic Zones:

Climate IVb
1. Type of Climate?

2. Long Term Testing Temperature (C)

3. Long Term Testing Humidity (RH)

1. “Do not refrigerate or freeze”

2. “Do not freeze”

3. ‘Protect from light’

4. “Store and transport not above 30 C”

5. “Store in dry conditions”

Limiting Factors:
1. Drug Products that cannot tolerate refrigeration

2. Drug Products that cannot tolerate freezing

3. Light-sensitive Drug Products

4. Drug Products that cannot tolerate excessive heat (e.g. suppositories)

5. Hygroscopic Drug Products
   

1. Conditions

2. 60 C

3. 75% RH or greater

4. 0.1N HCl

5. 0.1N NaOH

6. 3% H2O2

7. Metal hallide, Hg, Xe lamp, or UV-B/Fluorescent

8. 0.05M Fe2+ or Cu2+

Typical Stress Conditions:

1. Stress factor

2. Heat

3. Humidity

4. Acid

5. Base

6. Oxidative

7. Photolytic

8. Metal ions (optional)
   

Impurity Detection

Impurities are unwanted components in pharmaceutical products arising from manufacturing and storage.

Impurity Detection

The impurity profile accounts for the types and amounts of impurities present in a product.

Pharmacovigilance

In impurity detection, it involves detecting and assessing drug-related problems, ensuring drug safety and effectiveness.

1. Known impurities (specified impurities) arise from raw materials and manufacturing processes

2. Unknown impurities

3. Sources include drug substances, excipients, and contamination during manufacturing or storage.

Type and Sources of Impurities (3)

1. incosistent

2. consistent

1. Unspecified impurities of unknown structure

2. Specified unidentified impurities

Guidelines on Impurities

• Guidelines are provided by pharmacopeias (USP, EP, BP, JP), regulatory agencies (FDA), and ICH.

• Specific chapters detail control measures for organic impurities, residual solvents, and elemental impurities.

Analysis of Impurities

● Analytical methods include chromatography, spectroscopy, and other techniques for detecting and quantifying impurities.

● The impurity profile is established during the initial investigational new drug (IND) filing and monitored throughout the drug's lifecycle.

● Detailed knowledge of the preparation of the drug substance

● Starting materials, reaction intermediates, reagents and solvents should be controlled at each stage of the synthesis

● High-quality starting materials

● High-quality reagents

● Knowledge on how the drug substance degrades

● Tight control of process conditions

● Additional purification steps

○ Crystallization for synthetic drugs

HOW TO CONTROL PROCESS IMPURITIES FROM DRUG SUBSTANCE (OR API) (7)

● The focus of Drug Product impurities is usually limited to degradation products

● Knowledge of the formulation process should be essential

○ Are there solvents involved, heat, water, etc.?

● Most of the potential impurities in formulation arise during the formulation process and its subsequent degradation

HOW TO CONTROL DEGRADATION PRODUCTS FROM DRUG PRODUCT (OR FINISHED DOSAGE FORM) (3)