Generic drug approval is a regulatory process that allows for the production and sale of drugs that are equivalent to brand-name drugs in dosage, safety, strength, route of administration, quality, performance characteristics, and intended use, but at a lower cost. This process ensures that generic drugs meet the same rigorous standards as their brand-name counterparts, facilitating access to affordable medications while maintaining public health safety.

Generic Drug Approval

Regulatory Process

Production and sale of drugs

Brand-name drugs are special medicines made by big companies that have unique names and are protected by rules so others can't copy them for a while. These drugs are often more expensive, but they are trusted because they have been tested a lot to make sure they are safe and work well.

Brand-Name Drugs

Dosage refers to the specific amount of a medication or substance to be taken at one time or over a specified period, crucial for achieving the desired therapeutic effect while minimizing side effects. Accurate dosage is determined based on factors such as age, weight, and medical condition, and is essential for both efficacy and safety in treatment.

Dosage

Safety is the condition of being protected from harm or other non-desirable outcomes, often achieved through preventive measures and risk management. It encompasses a wide range of disciplines, including engineering, psychology, and public health, to ensure the well-being of individuals and communities.

Safety

Strength is the ability to exert force and withstand pressure, encompassing both physical capacity and mental resilience. It is a multifaceted attribute that is crucial for overcoming challenges and achieving goals, requiring a combination of muscle power, endurance, and psychological fortitude.

Strength

The route of administration refers to the path by which a drug, fluid, poison, or other substance is taken into the body. It significantly influences the drug's absorption, distribution, metabolism, and excretion, thereby affecting its efficacy and safety profile.

Route Of Administration

Quality

Performance Characteristics

Intended use refers to the specific purpose or function that a product, system, or service is designed to fulfill, which guides its development, marketing, and regulatory compliance. It is crucial for ensuring that the product meets safety and performance standards and aligns with user expectations and legal requirements.

Intended Use

Lower cost

Affordable medications

Public Health Safety involves the prevention of diseases, prolongation of life, and promotion of health through organized efforts and informed choices of society, organizations, public and private sectors, communities, and individuals. It requires a collaborative approach to ensure the well-being of populations by addressing social, economic, and environmental determinants of health.

Concepts

Relevant Degrees

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