Development strategies for IVIVC in an industrial environment

Biopharmaceutics & Drug Disposition
Jack A Cook

Abstract

Product development is typically challenging. There is a strong desire to understand critical performance factors early in order to optimize formulations for Phase III trials or marketing approval. However, over 90% of drugs entering development in humans do not make it to the market. Thus there is a tremendous risk that resources spent early in development will be wasted as candidates attrite. To overcome this apparent dilemma, a Bayesian approach is suggested. In 'traditional' product development, clinical study designs are typically relatively assumption free and often do not consider learning from earlier investigations. A Bayesian approach is one in which prior information is considered when interpreting the results of the current study. A candidate IVIVC can be developed at the earliest stage of clinical development. Subsequently there are multiple opportunities within a typical development program to assess the performance of the preliminary IVIVC as new formulations are introduced. With each introduction, there is an opportunity to either confirm the adequacy of the IVIVC or to identify the need for development of a more predictive dissolution test and IVIVC.

References

Jun 8, 2001·Journal of Controlled Release : Official Journal of the Controlled Release Society·V R Uppoor
Aug 22, 2001·Biopharmaceutics & Drug Disposition·N B ModiS K Gupta
Jun 9, 2004·Current Opinion in Chemical Biology·Mike M Hann, Tudor I Oprea
Aug 3, 2004·Nature Reviews. Drug Discovery·Ismail Kola, John Landis
Mar 10, 2009·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Karl Broich, UNKNOWN Committee for Medicinal Products for Human Use
Aug 26, 2010·Molecular Pharmaceutics·Jack A CookJames E Polli
Aug 31, 2011·Journal of Experimental Psychology. General·Thomas L Griffiths, Joshua B Tenenbaum

❮ Previous
Next ❯

Citations

Jul 3, 2015·Drug Development and Industrial Pharmacy·Ignacio González-GarcíaMarival Bermejo
Apr 27, 2018·Drug Development Research·Shery Jacob, Anroop B Nair
Jan 24, 2019·The AAPS Journal·Cordula StillhartFilippos Kesisoglou
Feb 27, 2019·The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry·Jacqueline Samantha WomersleySoraya Seedat
Nov 29, 2020·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Bárbara Sánchez-DengraMarival Bermejo

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.