BCPS – Regulatory QUESTIONS & ANSWERS(LATEST UPDATE 2024)CORRECT 100% EXAM BUNDLE

What are the types of Discrete Data? Give examples. - ANSWER Nominal and ordinal What are the types of Continuous Data? Give examples. - ANSWER interval and ratio

FDA office of commissioner - ANSWER top office senate confirmation overall agency coordination FDA office of chief counsel - ANSWER legal affairs FDA office of regulatory affairs - ANSWER largest office all inspection and enforcement center for drug eval and research - ANSWER CDER

OTC medications in Hep C patients - ANSWER cirrhosiseither acetaminophen or NSAIDs can be used in patients without evidence of cirrhosis. Patients with cirrhosis should AVOID NSAIDs because they increase complications of cirrhosis with risk of bleeding and renal insufficiency as well as carry th...

Which health literacy assessment tool is available in both English and Spanish? - ANSWER Test of Functional Health Literacy in Adults-short version (s-TOFHLA) *7 min to take *assess literacy and numeracy USPSTF - ANSWER U.S Preventitive Services Task Force Which organization would have th...

What does the Practice of Pharmacy include? - ANSWER Interpretation, evaluation, dispensing, and/pr implementation of medical orders, and the initiation and provision of Pharmacist Care Services What are Pharmacist Care Services - ANSWER Provisions of patient care activities with or without the d...

New drug approval pathway - ANSWER NDA (New Drug Application) Generic drug approval pathway - ANSWER ANDA (Abbreviated New Drug Application) FDA's duties - ANSWER 1. Review and approval of NDA and ANDA 2. Determine if REMS is necessary

Unpaired T-test - ANSWER Continuous data 2 independent samples Paired T-test - ANSWER Continuous data 2 paired samples ANOVA - ANSWER Continuous outcome data Categorical exposure data 3+ independent variables

What are the three core elements required for a controlled substance diversion prevention program? - ANSWER core administrative elements, system level controls, and provider level controls What are the 4 components of a system level control? - ANSWER automation and technology, HR management, moni...

FDA office of commissioner - ANSWER top office senate confirmation overall agency coordination Food and Vet medicine (baby food animals) Global reg. operations and policy (reg stuff) Chief scientest (tox reserach

Independent/Dependent variables - ANSWER Independent= intervention Dependent= outcome of interest, change in response to an intervention Discrete variables - ANSWER only take a limited number of values within a given range, qualitative values Two types: nominal and ordinal Types of random va...

JCo requirements for a hospital formulary - ANSWER criteria must include inidcations, effectiveness, interactions, potential for errors and abuse, ADE's sentinel event advisories, populations, other risks, costs DUE - ANSWER Process used to assess the appropriateness of drug therapy by evaluatin...

ARDS Criteria (PaO2/FiO2): Mild 200:300 Moderate 100:200 Severe: <100 - ANSWER ARDS Criteria Mortality: Mild: 27% Moderate: 32% Severe: 45% CYP450 Inducers - ANSWER Carbamazepine Rifampin Barbiturates

What is primary literature - ANSWER reports of original research, theories, ideas and opinions - most current info at time of publication What is secondary literature - ANSWER indexing and abstracting databases used to organize primary and tertiary resources -- search yield list of citation...

____ is the most appropriate answer because there are no drug-drug interactions or contraindications / cautions in HIV - ANSWER Bictegravir n patients with persistent neutropenic fever despite anti-pseudomonal coverage, what should be considered? - ANSWER empiric antifungal therapy should be cons...