The Pharmaceutical Sciences in 2020: Report of a Conference Organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)

The Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (academicians, scientists, regulators, industrialists, venture capitalists) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The commentary here provides a summary of major research activities that will drive drug discovery and development, enabling technologies for pharmaceutical sciences, paradigm shifts in drug discovery, development and regulations, and changes in education to meet the demands of academia, industry and regulatory institutions for pharmaceutical sciences in 2020

Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)

Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meetingFacultad de Ciencias Exacta

Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)

Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meetingFacultad de Ciencias Exacta

The similarity question for biologicals and non-biological complex drugs

AbstractFor small – low molecular weight – molecule medicines a robust regulatory system has evolved over the years. This system guarantees high and constant quality of our (generic) medicines. Pharmaceutical equivalence and bioequivalence assessment are the pillars under that system. But there are complex medicines where the question of equivalence is more challenging to answer. For biologicals the paradigm of similarity rather than equality (the emergence of ‘biosimilars’) was developed in the past decade. This has been a program where an evolutionary, science based approach has been chosen by the frontrunner regulatory body, the EMA, with a ‘learn and confirm’ character.In addition, there is another group of complex drugs, the non-biological complex drugs, NBCDs, where the generic paradigm can be challenged as well. The NBCDs are defined as: 1. consisting of a complex multitude of closely related structures; 2. the entire multitude is the active pharmaceutical ingredient; 3. the properties cannot be fully characterized by physicochemical analysis and 4. the consistent, tightly controlled manufacturing process is fundamental to reproduce the product. NBCDs encompass product families such as the glatiramoids, liposomes, iron–carbohydrate colloids and many candidates of the group of the upcoming nanoparticulate systems. Following the main principles of regulatory pathways for biologicals (with appropriate product-by-product adjustments), instead of that for small molecules, would be the more logical strategy for these NBCDs.The status and outstanding regulatory issues for biosimilars and NBCD-similars/follow on versions were discussed at a conference in Budapest, Hungary (October 2014) and this commentary touches upon the issues brought up in the presentations, deliberations and conclusions

Biowaiver Monographs for Immediate‐Release Solid Oral Dosage Forms: Codeine Phosphate

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/106898/1/jps23977.pd

Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)

Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meetingFacultad de Ciencias Exacta

Principles and criteria in the development and optimization of topical therapeutic products : Sponsored by the American Association of Pharmaceutical Scientists (AAPS) and U.S. Food and Drug Administration (FDA)

This report derived from the dermatological workshop discusses the problems and issues in the development and optimization of topical therapeutic drug products. It provides a clear understanding and differentiation between transdermal and dermal products. The report also discusses the bioavailability/bioequivalence issues for topical therapeutic products.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/30099/1/0000471.pd