Biopharmaceutics Classification System

Biopharmaceutical Drug Disposition Classification System divides compounds into four categories supported their porosity and solubility. It is beneficial in predicting effects of outflow and uptake transporters on oral absorption further as on post absorption general levels following oral and endogenous dosing. To improve the efficiency of drug development and the review process by recommending a strategy for identifying expendable clinical bioequivalence tests and a class of immediate-release (IR) solid oral dosage forms for which bioequivalence may be assessed based on in vitro dissolution tests. To recommend methods for classification according to dosage form dissolution, along with the solubility and permeability characteristics of the drug substance.

An overview of biopharmaceutical single-use technologies, which aid the manufacturing process in overcoming such complex issues as sterilization and critical manufacturing parameters. Analysis of global market trends, with data from 2013 and 2014, and projections of CAGRs through 2019. In-depth discussion of key market segments, such as membrane adsorbers, bioreactors, mixing, tangential flow filtration, tubing, connectors, preassembled tubing and rigging, depth filtration, buffer containers, waste containers, samplers, media bags, and filter cartridges. The global revenue for single use technology reached $1.4 billion and $1.7 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.7% to nearly $3.0 billion for the period 2014-2019.

Biopharmaceutical Drug Disposition Classification System divides compounds into four categories supported their porosity and solubility. This organization is beneficial in predicting effects of outflow and uptake transporters on oral absorption further as on post absorption general levels following oral and endogenous dosing. Role of BCS and BDDCS in Drug Development, the aim of BCS is to characterize medicine that product of these medicine could also be eligible for a bio waiver of in vivo bioequivalence studies. 

To improve the efficiency of drug development and the review process by recommending a strategy for identifying expendable clinical bioequivalence tests and a class of immediate-release (IR) solid oral dosage forms for which bioequivalence may be assessed based on in vitro dissolution tests. To recommend methods for classification according to dosage form dissolution, along with the solubility and permeability characteristics of the drug substance.

Class Boundaries:

  1. A drug substance is considered HIGHLY SOLUBLE when the highest dose strength is soluble in < 250 ml water over a pH range of 1 to 7.5.
  2. A drug substance is considered HIGHLY PERMEABLE when the extent of absorption in humans is determined to be > 90% of an administered dose, based on mass-balance or in comparison to an intravenous reference dose.
  3. A drug product is considered to be RAPIDLY DISSOLVING when > 85% of the labeled amount of drug substance dissolves within 30 minutes using USP apparatus I or II in a volume of < 900 ml buffer solutions

An overview of biopharmaceutical single-use technologies, which aid the manufacturing process in overcoming such complex issues as sterilization and critical manufacturing parameters. Analysis of global market trends, with data from 2013 and 2014, and projections of CAGRs through 2019. In-depth discussion of key market segments, such as membrane adsorbers, bioreactors, mixing, tangential flow filtration, tubing, connectors, preassembled tubing and rigging, depth filtration, buffer containers, waste containers, samplers, media bags, and filter cartridges. The global revenue for single use technology reached $1.4 billion and $1.7 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.7% to nearly $3.0 billion for the period 2014-2019.

  • Types of BCS
  • Parameters of Biopharmaceutical Classification System
  • Biopharmaceutics Drug Disposition Classification System
  • Role of BCS and BDDCS in Drug Development
  • Class I - High Permeability, High Solubility
  • Class II - High Permeability, Low Solubility
  • Class III - Low Permeability, High Solubility
  • Class IV - Low Permeability, Low Solubility

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