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

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

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/41492/1/11095_2004_Article_375175.pd

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

This study sought to determine whether there is an evidence base for drug manipulation to obtain the required dose, a common feature of paediatric clinical practice. A systematic review of the data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, contamination and comparison of methods of manipulation were included. Case studies and letters were excluded. Fifty studies were eligible for inclusion, 49 of which involved tablets being cut, split, crushed or dispersed. The remaining one study involved the manipulation of suppositories of one drug. No eligible studies concerning manipulation of oral capsules or liquids, rectal enemas, nebuliser solutions, injections or transdermal patches were identified. Twenty four of the tablet studies considered dose accuracy using weight and/or drug content. In studies that considered weight using adapted pharmacopoeial specifications, the percentage of halved tablets meeting these specifications ranged from 30% to 100%. Eighteen studies investigated bioavailability, pharmacokinetics or clinical outcomes following manipulations which included nine delayed or modified release formulations. In each of these nine studies the entirety of the dosage form was administered. Only one of the 18 studies was identified where drugs were manipulated to obtain a proportion of the dosage form, and that proportion administered. The five studies that considered patient perception found that having to manipulate the tablets did not have a negative impact on adherence. Of the 49 studies only two studies reported investigating children. This review yielded limited evidence to support manipulation of medicines for children. The results cannot be extrapolated between dosage forms, methods of manipulation or between different brands of the same drug