Overview of New Drug Development

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Development of most new drugs from discovery to marketing approval usually takes:
9 years or more
The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 subjects in each arm. Which of the following best describes the clinical phase of this study?
Phase II
Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?
Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
Preclinical
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?
Phase I
For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?
Preclinical data

Which of the following are the three principles included in the Belmont Report? Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has maximized benefits and minimized risks.
Which of the following best describes the principle of informed consent as described in the Belmont Report? Information, comprehension, voluntariness.
Development of most new drugs, from discovery to marketing approval, usually takes: 9 years or more
Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study? Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? Preclinical
For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure? Preclinical data
The ICH GCP guidelines: Set standards for the design, conduct, monitoring and reporting of clinical research.
In the United States, following the ICH E6 guideline is: Voluntary for FDA-regulated drug studies.
ICH E6 has broader requirements than FDA or HHS concerning the confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guidelines, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject’s medical records
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Identification of study risks to determine which may safely be omitted from continual monitoring.
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? IND report
Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? The study is not intended to be reported to FDA to support a new indication or support a labelling change.
The investigational product dispensing or administration information for the sponsor is recorded on the: Case report form
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have an equal or greater benefit to the subject. The investigator should do which of the following? Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. “Increased WBC count” is not listed in the Investigator’s Brochure (IB) as an adverse event. The investigator should: Report the elevated WBC to the sponsor as an unexpected adverse event
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff? Site initiation visit
Which of the following best describes when the majority of case report form (CRF) data are verified against source record information? Periodic site visits

Development Of Most New Drugs, From Discovery To Marketing Approval, Usually Takes:

  • 2 years
  • 5 years or more
  • 7 years
  • 9 years or more

Explanation:
There are various drug development processes to identify the chemical compounds that need development and marketing. Currently, the chemical and biological sciences for pharmaceutical development monopolies 5,000 – 10,000 chemical compounds.

The chemical compounds are first screened, about 250 of them enter the process of preclinical testing, and five move forward to clinical testing. The entire process of drug making to their marketing can take from 9 to 15 years.

Here are the various development phases of drugs.

Drug Development Phases

Several processes of the drug industry go through the finalizing of a drug to make it to the finished sale of the drug. One of the main phases of drug development is Food and Drug Administration (FDA) approval. Below are the five comprehensive phases to go through for drug development.

Phase 1: Discovery And Development
Each drug starts its development process in the lab. Pharma companies look after the research and development of drugs, including scientific study and innovations. They receive funds from the government, grants, revenues, and other sources as well.

Phase 2: Preclinical Research
After the discovery of the drug, it passes through preclinical and clinical research backed by supporting reports in its review process. The preclinical study is the basis of the preliminary phase that includes drug testing on animals. Other kinds of tests are implemented for safety flags.

Phase 3: Clinical Research
Clinical research is one of the significant steps for drug development processes. After being cleared in the preclinical trials, the drug moves forward to the clinical research that tests the drugs on humans.

Drug companies, along with the FDA, have certain standards for clinical trials. They involve professionals in scientific testing. The selection criteria for humans that are to be seated for a drug trial, the clinical research setup, and more are taken care of in this process.

Phase 4: FDA Review
The Food and Drug Administration is one of the primary reviewers of the drug market. The highest drug testing standards take almost 10 to 15 years approximately before approval through the three-drug development phases.

Phase four is where the drug companies submit their documentations and their findings for review by the FDA. After an acceptance post-submission, the FDA responds within 6 to 10 months.

Phase 5: FDA Post-Market Safety Monitoring
There are many factors to ensure post-approval safety monitoring of a drug. The FDA is responsible for the marketing of all kinds of drugs for accuracy. It also takes into account all sorts of complaints and problems associated with the drug.

Therefore, the FDA also has the power to pull back drug sales and also issue warnings. The FDA is entitled to perform routine manufacturing inspections. Plus, it also works for patent protections and generic drug transitions.

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