Pharmaceutics I Exam 1 Practice (FIncher)

Which establishes requirements for 503a traditional compounding pharmacies and for 503b outsourcing facilities?

Which created 10 or 11 digit National Drug Code (NDC)?

Which of the following concepts does NOT relate to pharmacokinetics?

Which created the Abbreviated New Drug Application (ANDA) ?

Which of the following describes the release of a drug from the body through the kidneys or other routes?

___________ are drugs with no accepted medical use, or other substances with a high potential for abuse

Recall: use of or exposure to a violative product may cause temporary health issues or low chance of health consequences

Which of the following describes the process by which drugs undergo chemical reactions in the body catalzed by enzymes?

Which enacted to decrease the # of medically uninsured & improve quality/reduce overall costs of health care in the US?

Which is credited with creating a more rapid application review process and faster approval of new drug products?

________ must be submitted to the FDA before human trials & must contain all information currently known about the drug

Which of the following can be found in the United States Pharmacopeia (USP)?

Which of the following is considered the study of what the drug does to the body?

ExpIND trials in 1000-5000 patients that last 1-4 yrs & study safety, effectiveness & dosage; 25-30% successfully tested

ExpIND trials in 100-500 patients that last several months - 2 yr & study effectiveness; 33% drugs tested successfully

Which of the following is not a quantitative measurement?

Which created distinction btw “Rx Only” or Legend drugs and over the counter products. Established prescription refills?

If 80 mg of a drug with a t_1/2 of 4 hours is given by IV injection, what conc. of the drug remains after 8 hours?

Which of the following describes the uptake of a drug into the bloodstream?

_________ is an active ingredient that has never before been marketed in the US in any form

Drugs taken by which route of administration always have 100% bioavailability? (The only ROA that has this ability)

____ are drugs w accepted medical uses & high potential for abuse; may lead to severe psychologic or physical dependence

Which of the following describes the release of the drug from its dosage form?

Which of the following is true regarding the FDA's stance on dietary supplements?

Which regulatory framework administered by the DEA established 5 Schedules of Drugs?

________ is the volume of blood plasma cleared of drug per unit time

________ examines the physiochemical properties of drugs and dosage forms as it relates to dosage form design

_________ is an indicator of how well the drug is either retained in the blood plasma or distributed in the body

Non-systemic = localization or not effecting the entire body. Which of the following areas is considered non-systemic?

ExpIND trials in 20-100 patients that last up to 1 year and examine drug safety; 70% of drugs successfully tested

How do we get drugs to their site of action?

Which provides tax credits and marketing exculsivity as incentives for costly research on rare diseases?

In general, how do drugs work?

Systemic = all over or effects the entire body. Which of the following areas is NOT considered systemic? (Non-systemic)

Permits the use of an investigational drug in patients with life-threatening diseases who are not enrolled in the study

Which created an Investigational New Drug Application (IND) that must be approved before an NDA can start?

Which of the following can be found in the National Formulary (NF) that cannot be found in USP?

________ is the time required for plasma concentration of a drug to decrease by 50%

Which regulates manufacturer’s claims of therapeutic benefit with passage of the Sherley Amendment?

______ is the proportion (% or fraction) of an administered dose of unchanged drug that reaches systemic circulation

Which route of administration does NOT match the administration site?

Which is usually filed for duplicates (generic copies) of drug products already approved under a full NDA?

Which created the FDA and requires that drugs must be approved by the FDA upon submission of an NDA?

Recall: use of or exposure to a violative product is not likely to cause serious adverse health consequences

Examines the relationship btw physicochemical properties of drugs, dosage form, & ROA on drug absorption into the body

ExpIND trials in very limited patients (< 15) before dose escalation & tolerability studies; usually, < 7 days exposure

Which can be filed by the drug manufactorer following three successful phases of clinical testing?

_____ studies the movement of drugs w/in the body & examines the fate of drugs in the body upon release from dosage form

Which route of administration does NOT match the administration site?

Recall: use of or exposure to a violative product could cause serious adverse health issues or death

What is one major disadvantage of the oral route of administration?

Which of the following is considered the study of what the body does to the drug?

Which of the following describes the process by which drugs are delivered to various parts of the body?

What are the two most common ways to measure drug amount/concentration in the body?

_________ are medications developed to treat rare diseases, which are defined as affecting <65/100,000 people

Which required drugs marketed interstate to comply with their claimed standards for strength, purity, and quality?