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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
May 14-15, 2018 | Montreal, Canada
Global Summit on
Biopharma & Biotherapeutics
The International Conference on Harmonization (ICH) M9:
Biopharmaceutics Classification System-Based Biowaivers
was recently adopted. A biowaiver allows for in vitro testing to
be used in lieu of in vivo bioavailability and/or bioequivalence
studies to facilitate product approval, where solubility and
permeability are not expected to impede bioavailability. ICHM9
should minimize unnecessary in vivo studies in man and allow
greater public access to medicines. However, this approach is
not always universally aligned or recognized. The biggest area
of concern is whether solubility should be based on the highest
therapeutic dose or on the highest strength of the medicinal
product. Different approaches to assessing permeability, i.e. in
vitro or in vivo assessments, will also require harmonization.
Thus, far biowaivers have been restricted to pharmaceutical
equivalents and primarily to BCS class I compounds. There
has been widespread concern regarding the effect of different
excipientsonthepermeabilityofthedrugsubstanceandthereby
the bioavailability of different formulations. For example, FDA
guidance states, “Unlike for BCS class 1 products, for a biowaiver
to be scientifically justified, BCS class 3 test drug product
must contain the same excipients as the reference product.
This is due to the concern that excipients can have a greater
impact on absorption of low permeability drugs.” Whilst, it is
certainly true that “certain excipients, such as surfactants (e.g.,
polysorbate 80) and sweeteners (e.g., mannitol or sorbitol) may
be problematic”, it is by no means true that all excipients can
adversely influence absorption. Consequently, ICH M9 faces
significant challenges and a target date of 2Q 2019 for step 4
implementation may be difficult to achieve.
Speaker Biography
David P Elder has nearly 40 years of service within the pharmaceutical industry
(Sterling, Syntex and for the last two decades with GSK). He is now an independent
CMC Consultant and has broad based experience in excipients, biopharmaceutics, drug
product and analytical method development. He obtained his PhD in crystallography
from the University of Edinburgh. He is a visiting Professor at King’s College, London.
He is a member of the British Pharmacopoeia. He is the immediate past Chairman of
JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory
Board for the Journal of Pharmaceutical Sciences. He has published 114 and presented
17 webinars and 133 presentations. He has Co-edited one book on the analytical
characterization and separation of oligonucleotides and their impurities (with George
Okafo and Mike Webb) and is editing a second book on the ICH quality guidelines (with
Andy Teasdale, AZ).
e:
David P Elder
GlaxoSmithKline, UK
ICHM9 Biopharmaceutics Classification System-based Biowaivers:
Challenges and opportunities