E02_01 Drug Regulation Flashcards
2017_Drug Regulation
Drug regulation, to be effective, must have the following except:
A. Legal framework B. Support from the public C. Adequate funding D. Executive administration under regulatory capture E. Competent staffing
D. Executive administration under regulatory capture
2017_Drug Regulation
Approval of new prescription drugs must have the following except:
A. Benefits outweigh the risks
B. Of proven safety and efficacy
C. Evaluation based solely on promise of economic potential
D. Manufacture complies with good quality standards and Good Manufacturing Practice
E. Adequate labeling
C. Evaluation based solely on promise of economic potential
2017_Drug Regulation
The most critical data related to proving that a new drug entity is really effective is:
A. Phase I clinical trials (first time in humans)
B. Phase II clinical trials (first time in patients)
C. Preclinical studies
D. Phase IV clinical trials
E. Phase III clinical trials (pivotal studies)
E. Phase III clinical trials (pivotal studies)
2017_Drug Regulation
All are components or descriptions of clinical trails except:
A. A test or experiment on human subjects
B. Bridges preclinical studies and the use of new drugs
C. First promulgated by the UD FDA, the first modern drug regulatory agency
D. Must comply with ethical criteria which include voluntary consent given by subjects
E. Good clinical practices and Helsinki Declaration
C. First promulgated by the UD FDA, the first modern drug regulatory agency
2017_Drug Regulation
Historical examples of harm caused by marketed regulated drugs and products except:
A. Melamin-tainted infant milk, 2008
B. Radionuclide contaminated milk following Chernobyl nuclear plant meltdown
C. Radionuclide contaminated milk following Three-Mile Island nuclear plant meltdown
D. Sulfanilamide Tragedy of 1937
E. Intussuception caused by First rotavirus vaccine
C. Radionuclide contaminated milk following Three-Mile Island nuclear plant meltdown
2017_Drug Regulation
The following describes the present-day national drug regulatory agency in the Philippines except:
A. Is directly under the Office of the President, similar to the FDA of the United States
B. Mandated by the Constitution of 1987 and EO 175 of May 22, 1987
C. Strengthened by RA 9711, known as the FDA Strengthening Law
D. Headed by a Director-General
E. Regulated food, drugs, cosmetics and a wide array of products
A. Is directly under the Office of the President, similar to the FDA of the United States
2018_Drug Regulation
Agreed arrangement of technical documents for systematic drug evaluation
A. ASEAN Common Technical Requirements
B. ASEAN Common Technical Dossier
C. ASEAN Implementing Rules and Regulations for Drug Regulation
B. ASEAN Common Technical Dossier
2018_Drug Regulation
The relationship between solubility, permeability, and the available concentration of the drug in the blood
A. BA or bioavailability
B. BE or bioequivalence
C. BD or biodegradable
D. AOTA
A. BA or bioavailability
2018_Drug Regulation
APEC declaration of ethical marketing of biopharmaceuticals
A. KL Declaration
B. Mexico [City] Declaration
C. Manila Declaration of 2015
D. APEC Declaration
B. Mexico [City] Declaration
2018_Drug Regulation
SSFFFC pertains to
A. Substandard, Spurious, Falsely-labelled, Falsified, Fraudulent, and Counterfeit medications
B. Special, Spurious, Falsely-labelled, Falsified, Fraudulent, and Counterfeit medications
C. Substandard, Spurious, Falsely-labelled, Fossilized, Fraudulent, and Counterfeit medications
D. AOTA
A. Substandard, Spurious, Falsely-labelled, Falsified, Fraudulent, and Counterfeit medications
2018_Drug Regulation
Principally talks about ethical marketing practices for biopharmaceuticals
A. KL Declaration
B. Mexico City Declaration
C. Manila Declaration of 2015
D. APEC Declaration
B. Mexico City Declaration
2018_Drug Regulation
True or False: The FDA Risk Management Protocols provide a guide for how companies should engage with regulators, especially in times of crisis
A. True
B. False
A. True
