Expanded trials Study guides, Class notes & Summaries

SOCRA EXAM TEST 2023 -| QUESTIONS and ANSWERS, Latest Update Graded 100%. When must an IND amendment be submitted and which section outlines this? - correct answers(21 CFR Part 312.31) -If there are changes to the protocol that affects safety of subjects, scientific quality of study, or scope of investigation -If a new Investigator is added to the study -Information amendments must be submitted for chemistry/microbiology, pharm/toxicology, or clinical Other submissions: --IND safety rep...

SOCRA Exam Review Questions and answers, Verified/ When isn't an IND application needed? - -IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR 312.23) - --Form 1571- cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research- literature review -Additional information (drug depende...

DDS Exam 1 Questions With 100% Correct Answers define indication specific use for a drug -its labeled use [FDA approved] 2 other names for psuedopolymorphs hydrates or solvates 2 requirements for FDA approval to market a drug product -show safety and efficacy -shop process control and validation (will they work the same every time) 2 main stages of drug development process are preclinical and clinical (study done in humans) 4 steps of drug discovery 1. "target" identification and ...

What is a statute? - correct answer -A law What is administrative law? - correct answer -Rules and regulations created by administrative agencies such as the FDA and Indiana Board of Pharmacy What was accomplished by the pure food and drug act of 1906? - correct answer -Prohibited adulteration and misbranding of foods and drugs in interstate commerce (does NOT include that misbranding includes false or misleading efficacy claims) What was accomplished by the food, drug, and cosmetic act...

DDS Exam 1 Questions With 100% Correct Answers verified by Expert Drug Development Pipeline - answer1. Drug Discovery 2. Biological Characterization and Preformulation Studies 3. IND 4. Clinical Trials, Final Development, Long Term Toxicity 5. NDA 6. Post-Marketing Target - answerUsually receptor Hit - answerMolecule that interacts with targets Lead - answerPrototype chemical that has desired biological or pharmacological activity Candidate - answerThe lead most suitable for further i...

Certified Clinical Research Professional (CCRP) Exam Study Guide. When isn't an IND application needed? - correct answer IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - correct answer FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human res...

Forward Chaining - correct answer Begin with the first SD- response component in the chain and then continue forward through the remaining SD-response components. Example: Teaching a child to brush their teeth from the beginning of the task with the SD "Brush your teeth" the child gets the tooth brush, turns on the cold water, puts the toothbrush under the water... eventually then gets towel, wipes mouth and hands and hangs towel up. The reinforcer will be AFTER THE TARGET STEP and the The...

Reciprocity correct answer: License transfer, from one state to another When are Pharmacists allowed to use telehealth? correct answer: 1. Patient gives confirmed consent 2. Make some effort to keep confidential Board of Pharmacy Newsletter correct answer: Published on a quarterly basis; considered official notice of any new rules, other things need to do Who is responsible for discipline in the realm of pharmacy in KY? correct answer: *Kentucky Board of Pharmacy* - Executive Dire...

PHR Acts and Laws Exam Questions & Answers 2023/2024 Age Discrimination Employment Act - ANSWER-ADEA 1967: prohibits discrimination on the basis of age for individuals age 40 and above. covers private and federal employers who have 20 EEs or more. Americans with Disabilities Act - ANSWER-1992: A law that guarantees equal opportunity for qualified individuals with disabilities -covers employers with 15 or more ees Pregnancy Discrimination Act - ANSWER-prohibits discrimination on the ...

CARD BCAT EXAM 2024 (GRADED) A+