Drug Development

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Which term refers to the dose that produces the desired effect in half the subjects?

TD50

Acute toxicity

Subacute toxicity

ED50 (correct)

What is the time frame for subacute/subchronic toxicity?

Six months or more

Two weeks to three months (correct)

Three months to six months

Within two weeks

What is the term for dose-dependent toxicity?

Chronic toxicity

Tolerance (correct)

TD50

ED50

What is the term for the dose that produces a specified toxicity endpoint in half the subjects?

TD50 Signup and view all the answers

What is the time frame for chronic toxicity?

Six months or more Signup and view all the answers

What is the primary focus of safety and toxicity considerations?

Additives, route of administration, dosage, frequency, drug interactions Signup and view all the answers

What is the term for exposing individuals to a milder form of disease?

Variolation Signup and view all the answers

Who is often considered the 'father of modern vaccination'?

Edward Jenner Signup and view all the answers

Which group of people practiced variolation before it was adopted by Westerners?

Turks, Arabs, and all of the Orientals Signup and view all the answers

Why is animal experimentation considered indispensable to drug development?

Cannot do these experiments on humans Signup and view all the answers

Which step in vaccine production involves adding components to stabilize, kill, and improve immunogenicity of the antigen?

Performing steps of purification Signup and view all the answers

What is the current state of vaccine manufacturing in the Philippines?

There is local capacity to make vaccines Signup and view all the answers

Which step in vaccine production involves transferring bulk antigen into discrete units of pre-filled syringes or vials?

Performing steps of purification Signup and view all the answers

What is required for the first two steps of vaccine production?

Intensive resources and thorough planning Signup and view all the answers

What is the primary purpose of conducting testing and quality control in vaccine production?

To ensure the quality of the vaccines Signup and view all the answers

What is the main reason why there is no present local capacity to make vaccines in the Philippines?

Lack of bulk antigen production Signup and view all the answers

What is the purpose of packaging pre-filled syringes/vials in vaccine production?

To distribute the vaccines Signup and view all the answers

What are the key steps involved in making vaccines?

Producing the bulk antigen, shifting/transfer bulk antigen into smaller containers, and packaging pre-filled syringes/vials Signup and view all the answers

What is the purpose of adding components to the antigen in vaccine production?

To stabilize, kill, and improve immunogenicity of the antigen Signup and view all the answers

What is the purpose of concentrating the harvested virus into a bulk antigen solution in vaccine production?

To produce the bulk antigen Signup and view all the answers