Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Mesenchymal stem cells from Shwachman-Diamond syndrome patients display normal functions and do not contribute to hematological defects.

Blood cancer journal·2012
Same author

Somatic SF3B1 mutation in myelodysplasia with ring sideroblasts.

The New England journal of medicine·2011
Same author

Null mutation of the Lmo4 gene or a combined null mutation of the Lmo1/Lmo3 genes causes perinatal lethality, and Lmo4 controls neural tube development in mice.

Molecular and cellular biology·2004
Same author

Antipsychotic drug treatment alters expression of mRNAs encoding lipid metabolism-related proteins.

Molecular psychiatry·2003
Same author

A prospective study of the incidence of the purple glove syndrome.

Epilepsia·2001
Same author

Preferential binding of human full-length XPA and the minimal DNA binding domain (XPA-MF122) with the mitomycin C-DNA interstrand cross-link.

Biochemistry·2001

Related Experiment Video

Updated: Jul 16, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Fee structure for investigational drug studies

J V Anandan1, M J Isopi, A J Warren

  • 1Department of Pharmacy Services, Henry Ford Hospital, Detroit, MI 48202.

American Journal of Hospital Pharmacy
|November 1, 1993
PubMed
Summary

A new fee structure for pharmacy-coordinated investigational drug services was developed using a task and time study. This ensures adequate reimbursement for pharmacy services and allows for appropriate personnel allocation.

Area of Science:

  • Pharmacy Practice
  • Clinical Research Management
  • Healthcare Economics

Background:

  • Investigational drug services are crucial for clinical trials.
  • Pharmacy departments often provide these services but may lack adequate reimbursement.
  • A clear fee structure is needed to support these specialized pharmacy services.

Purpose of the Study:

  • To develop and implement a sustainable fee structure for pharmacy-coordinated investigational drug services.
  • To ensure adequate financial reimbursement for pharmacy departments providing investigational drug services.
  • To facilitate appropriate resource allocation for investigational drug services.

Main Methods:

  • A pilot task and time study was conducted to identify cost elements.
  • Investigational drug services were analyzed across five phases and specific tasks.

More Related Videos

Monitoring of Nanodrug Accumulation in Murine Breast Cancer Metastases
09:48

Monitoring of Nanodrug Accumulation in Murine Breast Cancer Metastases

Published on: August 23, 2024

Studying Metabolic Brain Connectivity Using 2-Deoxy-2-[18F]Fluoro-D-Glucose Dynamic Positron Emission Tomography at the Single-subject Level
07:28

Studying Metabolic Brain Connectivity Using 2-Deoxy-2-[18F]Fluoro-D-Glucose Dynamic Positron Emission Tomography at the Single-subject Level

Published on: January 24, 2025

Related Experiment Videos

Last Updated: Jul 16, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Monitoring of Nanodrug Accumulation in Murine Breast Cancer Metastases
09:48

Monitoring of Nanodrug Accumulation in Murine Breast Cancer Metastases

Published on: August 23, 2024

Studying Metabolic Brain Connectivity Using 2-Deoxy-2-[18F]Fluoro-D-Glucose Dynamic Positron Emission Tomography at the Single-subject Level
07:28

Studying Metabolic Brain Connectivity Using 2-Deoxy-2-[18F]Fluoro-D-Glucose Dynamic Positron Emission Tomography at the Single-subject Level

Published on: January 24, 2025

  • Time elements for each task were determined to establish cost basis.

    • Main Results:

    • A tiered fee structure was derived, ranging from $2800 for standard protocols to $5700 for complex studies.
    • A newsletter was distributed to medical staff and principal investigators detailing the new services and costs.
    • The fee structure was successfully implemented, ensuring pharmacy services are reimbursed.

    Conclusions:

    • Implementing a pharmacy-developed fee structure ensures adequate reimbursement for investigational drug services.
    • This financial model supports the allocation of necessary personnel and resources.
    • Pharmacy-coordinated investigational drug services can be financially sustainable with appropriate fee structures.