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Related Concept Videos

Induction01:16

Induction

An emf is induced when the magnetic field in a coil is changed by pushing a bar magnet into or out of the coil. emfs of opposite signs are produced by motion in opposite directions, and the directions of emfs are also reversed by reversing poles. The same results are produced if the coil is moved rather than the magnet—it is the relative motion that is important. The faster the motion, the greater the emf. Additionally, there is no emf when the magnet is stationary relative to the coil.
A...
Inductors01:20

Inductors

An inductor, also known as a choke, is a circuit component created to have a specific inductance. Inductors are among the crucial circuit components used in modern electronics, along with resistors and capacitors. They serve as a barrier against changes in a circuit's current. An inductor tends to suppress current changes in an alternating-current circuit that are faster than desired. In a direct-current circuit, an inductor aids in preserving a constant current despite changes in the applied...
Inductors01:11

Inductors

An inductor is a passive component built to store energy within its magnetic field. It can be fabricated by coiling a wire around a magnetic core. When current is permitted to flow through this inductor, it is observed that the voltage across the inductor is directly proportional to the time rate of change of the current. Mathematically,
Indicators02:39

Indicators

Certain organic substances change color in dilute solution when the hydronium ion concentration reaches a particular value. For example, phenolphthalein is a colorless substance in any aqueous solution with a hydronium ion concentration greater than 5.0 × 10−9 M (pH < 8.3). In more basic solutions where the hydronium ion concentration is less than 5.0 × 10−9 M (pH > 8.3), it is red or pink. Substances such as phenolphthalein, which can be used to determine the pH of a solution, are called...
Induced Electric Fields: Applications01:27

Induced Electric Fields: Applications

An important distinction exists between the electric field induced by a changing magnetic field and the electrostatic field produced by a fixed charge distribution. Specifically, the induced electric field is nonconservative because it does not work in moving a charge over a closed path. In contrast, the electrostatic field is conservative and does no net work over a closed path. Hence, electric potential can be associated with the electrostatic field but not the induced field. The following...
Integration by Parts: Indefinite Integrals01:26

Integration by Parts: Indefinite Integrals

Integration by parts is a fundamental technique in calculus for evaluating integrals involving the product of two functions. It is particularly useful when direct integration is not feasible. The method is based on the product rule for differentiation, which states that the derivative of a product equals the derivative of the first function times the second, plus the first function times the derivative of the second. By integrating this identity and rearranging terms, the integration by parts...

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Synthesis of Indoxyl-glycosides for Detection of Glycosidase Activities
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Synthesis of Indoxyl-glycosides for Detection of Glycosidase Activities

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The IND application.

John W Ferkany1, Michael Williams

  • 1Surface Logix, Brighton, Massachusetts, USA.

Current Protocols in Pharmacology
|February 2, 2012
PubMed
Summary
This summary is machine-generated.

The Investigational New Drug (IND) application is crucial for initiating human clinical trials. It details a new drug

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Area of Science:

  • Biomedical Research
  • Drug Development
  • Regulatory Science

Background:

  • Translational biomedical research aims to treat unmet medical needs.
  • New drugs and biologics require regulatory approval before human testing.
  • The U.S. Food and Drug Administration (FDA) oversees drug development.

Purpose of the Study:

  • To describe the timing and content of an Investigational New Drug (IND) application.
  • To provide a global introduction to the IND process for new chemical entities (NCEs) and biologics.
  • To guide individuals with limited experience in the early stages of drug development.

Main Methods:

  • The unit outlines the essential components of an IND application.
  • It details the required information for FDA review.
  • The focus is on the initial regulatory submission for clinical trials.

Main Results:

  • The IND application is the primary document for initiating human clinical trials.
  • It requires comprehensive data on the NCE/biologic's biology, safety, toxicology, chemistry, manufacturing, and clinical plan.
  • FDA uses this information to assess risks and benefits.

Conclusions:

  • Understanding the IND application is vital for advancing new therapies to patients.
  • This process facilitates the safe introduction of novel drugs and biologics into human trials.
  • The IND application represents the first critical step in the drug development pathway.