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

Related Conference of Biopharmaceutics Classification System

August 02-03, 2018

10th World Congress on Pharmacology

Barcelona, Spain
February 18-19, 2019

14th World Congress on Pharmacology and Drug Safety

Amsterdam, Netherlands
August 28-29, 2018

10th World Congress on Neuropharmacology

Paris, France
September 13-14, 2018

8th World Congress on Chromatography

Prague, Czech Republic
September 17-18, 2018

15th International Conference on Pharmaceutical Formulations & Drug Delivery

| Philadelphia, Pennsylvania, USA
September 20-22, 2018

17th Annual Congress on Pharmaceutics & Drug Delivery Systems

Prague, Czech Republic
September 24-25, 2018

Middle East Pharmacy and Pharmaceutical Conference

Abu Dhabi, UAE
September 24-26, 2018

12th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
Chicago, Illinois, USA
September 24-26, 2018

7th International Conference on Clinical Trials

| Chicago, Illinois, USA
(10 Plenary Forums - 1 Event)
September 26-27, 2018

5th International Conference on Clinical Pharmacy and
Health Care

San Antonio, Texas, USA
September 28-29, 2018

11th World Congress on Pharmaceutical Sciences

| Montreal, Canada
October 24-25, 2018

13th International Conference on Biopharma and Biotherapeutics

Boston, Massachusetts, USA
November 05-07, 2018

18th Annual Pharma Middle East Congress

Abu Dhabi, UAE
November 08-09, 2018

17th World Congress on Drug Formulation & Drug Delivery

Auckland, New Zealand
November 14-15, 2018

13th World Congress on Pharmacology and Toxicology

Melbourne, Australia
November 15-16, 2018

9th Global Experts Meeting on Neuropharmacology

Berlin, Germany
November 16-17, 2018

5th Annual Congress on Clinical & Hospital Pharmacy

Tokyo, Japan
April 22-23, 2019

6th World Congress on Drug Discovery & Toxicology

Abu Dhabi, UAE
March 22-23, 2019

5th International Conference on Antibiotics

Chicago, Illinois, USA
March 25-26, 2019

World Congress on Pharmaceutical Biotechnology & Bioengineering

Orlando, Florida, USA
April 15-16, 2019

12th European Biosimilars Congress

Berlin, Germany
April 17-18, 2019

11th World Congress on Pharmacology & Therapeutics

Montreal, Canada
April 17-18, 2019

Annual Neurochemistry and Neuropharmacology Congress

| Montreal, Canada
May 15-17, 2019

4th Annual Congress on Nanomedicine and Drug Delivery

Hyatt Regency Osaka, Japan
May 20-21, 2019

21st Annual European Pharma Congress

Zurich, Switzerland
May 20-22, 2019

20th Asia-Pacific Pharma Congress

Tokyo, Japan
September 11-13, 2019

8th International Conference on Clinical Trials

| Orlando, Florida, USA

Biopharmaceutics Classification System Conference Speakers

Recommended Sessions

Related Journals

Are you interested in