Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development

Transcription

1 Toxicology - Problem Drill 24: Toxicology Studies in Pharmaceutical Development No. 1 of regulates all the drugs products manufactured and sold in the USA. (A) EMEA (B) IND (C) FDA (D) NDA (E) OSHA EMEA regulates all products in Europe. The IND is a regulatory document, not an agency. C. Correct! The FDA regulates all the drugs products manufactured and sold in the USA. The NDA is a regulatory document, not an agency. OSHA regulates occupational safety. The FDA regulates all the drugs products manufactured and sold in the USA. Its powers are granted under the FD&C (Food, Drug and Cosmetics) Act. The correct answer is (C).

2 No. 2 of is a non-clinical stage that utilizes both in vitro and in vivo studies to obtain pharmacology and toxicology data. (A) NDA (B) Preclinical testing (C) Phase I (D) Phase II (E) Phase III The NDA is the application to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. B. Correct! Preclinical testing is a non-clinical stage that utilizes both in vitro and in vivo studies to obtain pharmacology and toxicology data. Phase I is a clinical stage. Phase II is a clinical stage. Phase III is a clinical stage. Preclinical testing is a non-clinical stage that utilizes both in vitro and in vivo studies to obtain pharmacology and toxicology data. The goal of preclinical studies is to determine the safety and efficacy of the lead compound under investigation, prior to its administration to humans. The correct answer is (B).

3 No. 3 of The regulatory application to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. is the. (A) EMEA (B) IND (C) NDA (D) FDA (E) None of the above The EMEA regulates all products in Europe. Think of a different application to the FDA. C. Correct! The regulatory application to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. is the NDA. The FDA regulates all the drugs products manufactured and sold in the USA. One of these answers is correct! The regulatory application to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. is the NDA. The NDA tells the whole story of the drug, from manufacture to use inpatients. The correct answer is (C).

4 No. 4 of allows researchers to find potential candidates for preclinical and clinical trials for a target population. (A) Drug discovery (B) Preclinical testing (C) Phase I (D) Phase II (E) Phase III A. Correct! The goal of drug discovery is to find potential candidates for pre-clinical and clinical trials for a target population. This stage occurs before preclinical trials. Phase I is a clinical stage. Phase II is a clinical stage. Phase III is a clinical stage. The goal of drug discovery is to find potential candidates for pre-clinical and clinical trials for a target population. The correct answer is (A).

5 No. 5 of is a step in the drug discovery process. (A) Target identification (B) Assay development (C) Lead identification (D) Lead optimization (E) All of the above Think beyond this one step. Think beyond this one step. Think beyond this one step. Think beyond this one step. E. Correct! All of the answers are correct! Drug Discovery can be further divided into a series of steps: 1. Target identification 2. Assay development 3. Lead identification 4. Lead optimization 5. Pre-clinical evaluation The drug discovery process ends with the administration of the first human dose that leads to clinical trials. The correct answer is (E).

6 No. 6 of The goal of preclinical studies is to determine. (A) The protocol to follow during clinical trials. (B) The target of the new drug. (C) The safety and efficacy of the lead compound. (D) The identity of the lead compound. (E) The dose of drug that should be given to patients. Think of data needed before entering trials in humans. Think of data needed before entering trials in humans. C. Correct! The goal of preclinical studies is to determine the safety and efficacy of the lead compound under investigation, prior to its administration to humans. Think of data needed before entering trials in humans. Think of data needed before entering trials in humans. The pre-clinical testing stage, also known as stage 0, is a non clinical stage that utilizes both in vitro and in vivo studies to obtain pharmacology and toxicology data. A patent application is usually filed at this point to protect the intellectual property of the NCE. The goal of preclinical studies is to determine the safety and efficacy of the lead compound under investigation, prior to its administration to humans. The correct answer is (C).

7 No. 7 of The tells the whole drug story. (A) NDA (B) IND (C) FDA (D) EMEA (E) None of the above A. Correct! The NDA tells the whole drug story. The IND is submitted prior to Phase I. The FDA regulates all the drugs products manufactured and sold in the USA. The EMEA regulates all products in Europe. One of the above answers is correct! Upon successful completion of phase III trials, a New Drug Application (NDA) is filed with the FDA. This is an application to formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The NDA tells the whole drug story: what happened during the clinical tests what the ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged The correct answer is (A).

8 No. 8 of The sample size used for Phase I trials is: (A) healthy individuals. (B) individuals with the target disease. (C) individuals with target disease. (D) 100s-1000s individuals with target disease. (E) Monitors entire patient population. A. Correct! The sample size used for Phase I trials is healthy individuals. Healthy individuals are used in Phase I. Healthy individuals are used in Phase I. Healthy individuals are used in Phase I. Phase I is for drugs not yet approved for use in patients. Phase I asks the question, is the treatment safe? The sample size used for Phase I trials is very small; healthy individuals are tested with informed consent. At this stage full resuscitation and medical backup should be available and vital signs, plasma and serum levels and adverse events need to be monitored. The dose is increased in single dose tiers and individuals are monitored at every stage. The correct answer is (A).

9 No. 9 of Phase III asks the question: (A) Is this drug safe? (B) Is this drug effective? (C) Is this drug better? (D) What else do we need to know? (E) What else can the drug are used for? Think of comparative studies to current treatments. Think of comparative studies to current treatments. C. Correct! Phase III asks the question, is this drug better? Think of comparative studies to current treatments. Target identification is part of the drug discovery process. Phase III asks if this new drug is better than the currently available therapy. The objectives of Phase III trials are to determine: Drug-drug interactions Dosage intervals Risk-benefit information Efficacy and safety subgroups The correct answer is (C).

10 No. 10 of The is submitted to the FDA to begin clinical trials. (A) EMEA (B) IND (C) ANDA (D) FDA (E) Target identification The EMEA regulates all products in Europe. B. Correct! The IND is submitted to the FDA to begin clinical trials. The NDA is a type of New Drug Application. FDA approves a new pharmaceutical for sale and marketing in the U.S. One of the above answers is correct. If the results of pre-clinical trials are promising, an IND is submitted to the FDA to begin clinical trials. The IND package will contain all relevant data from pre-clinical testing to convince the FDA that the potential drug is likely to be safe in humans. The correct answer is (B).