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

Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
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...
Determination of Multiple Dosing Parameters: Loading and Maintenance Doses01:25

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...

You might also read

Related Articles

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

Sort by
Same author

A case of aneurism of the popliteal artery, cured by compression of the femoral artery.

Medico-chirurgical transactions·2010
Same author

Bowl-shaped and highly inert bis(mu-hydroxo)-platinum(II) dimer.

Inorganic chemistry·2001
Same author

The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor fluvastatin: effect on human cytochrome P-450 and implications for metabolic drug interactions.

Drug metabolism and disposition: the biological fate of chemicals·1999
Same author

Relative bioavailability of Neoral versus Sandimmune in the presence of a P450IIIA and P-glycoprotein inhibitor.

Transplantation proceedings·1998
Same author

Theonellapeptolide IIIe, a new cyclic peptolide from the New Zealand deep water sponge, Lamellomorpha strongylata.

Journal of natural products·1998
Same author

Pharmacokinetics of abecarnil in patients with renal insufficiency.

Clinical pharmacology and therapeutics·1996

Related Experiment Video

Updated: Jul 9, 2026

A Method for Microinjection of Patiria minata Zygotes
08:48

A Method for Microinjection of Patiria minata Zygotes

Published on: September 1, 2014

Innovative early development regulatory approaches: expIND, expCTA, microdosing.

W T Robinson1

  • 1Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. William.robinson@novartis.com

Clinical Pharmacology and Therapeutics
|December 20, 2007
PubMed
Summary

Regulatory guidances for exploratory investigational new drugs (INDs) and clinical trial applications (CTAs) aim to streamline drug development. This review examines the history and industry use of these important efficiency initiatives.

More Related Videos

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning
09:22

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning

Published on: June 22, 2015

Related Experiment Videos

Last Updated: Jul 9, 2026

A Method for Microinjection of Patiria minata Zygotes
08:48

A Method for Microinjection of Patiria minata Zygotes

Published on: September 1, 2014

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning
09:22

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning

Published on: June 22, 2015

Area of Science:

  • Drug Development and Regulatory Science
  • Pharmaceutical Policy and Innovation

Background:

  • The Food and Drug Administration (FDA) Critical Path Initiative and the European Medicines Agency (EMA) Road Map highlight the need for efficient drug development processes.
  • Emerging regulatory guidances for exploratory Investigational New Drugs (INDs) and Clinical Trial Applications (CTAs) represent a key response to these calls for efficiency.

Purpose of the Study:

  • To review the historical development of guidances for exploratory INDs/CTAs.
  • To analyze the industry's experience and utilization of these guidances to date.

Main Methods:

  • Historical review of regulatory guidance evolution.
  • Analysis of industry adoption and practical application of exploratory IND/CTA guidances.

Main Results:

  • Exploratory IND/CTA guidances have emerged as a significant initiative to improve drug development efficiency.
  • The article synthesizes the history and current industry experience with these guidances.

Conclusions:

  • These guidances are crucial for optimizing the early stages of drug development.
  • Continued industry engagement with and refinement of these regulatory pathways are essential for future pharmaceutical innovation.