Characterizing drug product continuous manufacturing residence time distributions of major/minor excipient step

Leo Manley1, Zhenqi Shi1

  • 1Process Design and Development, Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN 46285, United States.

Related Concept Videos

Continuous Charge Distributions01:17

Continuous Charge Distributions

Imagine a bucket of water. It contains many molecules, of the order of 1026 molecules. Thus, although it contains discrete elements (molecules) at the microscopic level, macroscopically, it can be considered continuous. Small volume elements of water, infinitesimal compared to the bulk of the bucket's volume, still contain many molecules. Under this framework, quantized matter is approximated as continuous for practical purposes.
The electric charge can also be subjected to an analogical...
8.4K
Infrared (IR) Spectroscopy: Overview01:09

Infrared (IR) Spectroscopy: Overview

When electromagnetic radiation passes through a material, atoms or molecules transition from a lower to a higher energy state by absorbing radiation corresponding to the energy difference between the two states. The absorption of infrared (IR) radiation causes transitions between vibrational energy levels in a molecule. Therefore, IR spectroscopy is a useful analytical tool for determining the molecular structure of molecules.
Different compounds display unique properties due to their...
5.1K
Noncompartmental Analysis: Mean Residence Time01:05

Noncompartmental Analysis: Mean Residence Time

According to statistical moment theory, mean residence time (MRT) is an important measure in pharmacokinetics. MRT can be defined as the expected mean of a probability density function distribution. It provides valuable insights into drug disposition in the body.
After the administration of a drug through intravenous bolus injection, the drug molecules are distributed throughout the body and remain there for varying periods. The MRT represents the average time these drug molecules stay in the...
610
Distributions to Estimate Population Parameter01:26

Distributions to Estimate Population Parameter

The accurate values of population parameters such as population proportion, population mean, and population standard deviation (or variance) are usually unknown. These are fixed values that can only be estimated from the data collected from the samples. The estimates of each of these parameters are sample proportion, the sample mean, and sample standard deviation (or variance). To obtain the values of these sample statistics, data are required that have particular distribution and central...
5.1K
Steps in the Modeling Process01:14

Steps in the Modeling Process

Albert Bandura's theory of observational learning identifies four critical processes: attention, retention, motor reproduction, and reinforcement or motivation.
Attention is the first necessary component for observational learning. It involves focusing on what the model is doing and saying. For example, if you decide to take a drawing class to enhance your skills, you need to pay close attention to the instructor's words and hand movements. The characteristics of the model significantly...
683
Drug Distribution: Volume of Distribution01:25

Drug Distribution: Volume of Distribution

The volume of distribution refers to the theoretical volume necessary to contain the entire amount of an administered drug at the same concentration observed in the blood plasma. The body's intracellular fluid compartment, which makes up two-thirds of the total body water, is contrasted with the extracellular fluid compartment—comprising plasma and interstitial fluid—that accounts for one-third. The volume of distribution can vary depending on the characteristics of the drug.
7.5K