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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Methodologies in Biosimilar Product Development (Hardcover)
Loot Price: R5,572
Discovery Miles 55 720
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Methodologies in Biosimilar Product Development (Hardcover)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Methodologies for Biosimilar Product Development covers the
practical and challenging issues that are commonly encountered
during the development, review, and approval of a proposed
biosimilar product. These practical and challenging issues include,
but are not limited to the mix-up use of interval hypotheses
testing (i.e., the use of TOST) and confidence interval approach, a
risk/benefit assessment for non-inferiority/similarity margin,
PK/PD bridging studies with multiple references, the detection of
possible reference product change over time, design and analysis of
biosimilar switching studies, the assessment of sensitivity index
for assessment of extrapolation across indications without
collecting data from those indications not under study, and the
feasibility and validation of non-medical switch post-approval. Key
Features: Reviews withdrawn draft guidance on analytical similarity
assessment. Evaluates various methods for analytical similarity
evaluation based on FDA's current guidelines. Provides a general
approach for the use of n-of-1 trial design for assessment of
interchangeability. Discusses the feasibility and validity of the
non-medical switch studies. Provides innovative thinking for
detection of possible reference product change over time. This book
embraces innovative thinking of design and analysis for biosimilar
studies, which are required for review and approval of biosimilar
regulatory submissions.
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