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Pharmacology: Medications from Production to Prescribing

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Pharmacology: Medications from Production to Prescribing

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Questions and Answers

What is the primary purpose of involving several thousand volunteers with a disease or condition?

To regulate the biopharmaceutical industry
To monitor the efficacy of a newly approved drug
To ensure the long-term safety and effectiveness of a drug (correct)
To promote the development of the pharmaceutical industry

What is the main objective of the SFDA?

To ensure the safety, efficacy, and quality of pharmaceuticals (correct)
To restrict the availability of pharmaceuticals
To regulate clinical trials only
To promote the development of the biopharmaceutical industry

What is one of the key functions of the SFDA?

To grant licenses to pharmaceutical companies (correct)
To conduct clinical trials
To prescribe drugs to patients
To manufacture pharmaceuticals

What is the purpose of post-marketing surveillance by the SFDA?

To ensure drug safety (B) Signup and view all the answers

What is included in the Prescribing Information (PI) content?

Indications, dosage, contraindications, warnings, and adverse reactions (A) Signup and view all the answers

How often should the Prescribing Information (PI) be updated?

Regularly to reflect new scientific information (B) Signup and view all the answers

What is the purpose of the DEA's Controlled Substances Prescriptions Standards?

To ensure valid prescriptions (C) Signup and view all the answers

What is required for a prescription to be considered valid under the DEA's standards?

A patient name, drug name, and prescriber signature (B) Signup and view all the answers

What is an example of a special circumstance covered by the DEA's regulations?

Both A and B (C) Signup and view all the answers

What is the role of the SFDA in clinical trials?

To regulate and monitor clinical trials (C) Signup and view all the answers