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With potentially high specificity and low toxicity, biologicals
offer promising alternatives to small-molecule drugs. Peptide
therapeutics have again become the focus of innovative drug
development efforts backed up by a resurgence of venture funds and
small biotechnology companies. What does it take to develop a
peptide-based medicine? What are the key challenges and how are
they overcome? What are emerging therapeutics for peptide
modalities? This book answers these questions with a holistic story
from molecules to medicine, combining the themes of design,
synthesis and clinical applications of peptide-based therapeutics
and biomarkers. Chapters are written and edited by leaders in the
field from industry and academia and they cover the
pharmacokinetics of peptide therapeutics, attributes necessary for
commercially successful metabolic peptides, medicinal chemistry
strategies for the design of peptidase-resistant peptide analogues,
disease classes for which peptide therapeutic are most relevant,
and regulatory issues and guidelines. The critical themes covered
provide essential background information on what it takes to
develop peptide-based medicine from a chemistry perspective and
views on the future of peptide drugs. This book will be a valuable
resource not only as a reference book for the researcher engaged in
academic and pharmaceutical setting, from basic research to
manufacturing and from organic chemistry to biotechnology, but also
a valuable resource to graduate students to understand discovery
and development process for peptide-based medicine.
Peptide therapy has become a key strategy in innovative drug
development, however, one of the potential barriers for the
development of novel peptide drugs in the clinic is their
deficiencies in clearly defined chemistry, manufacturing and
controls (CMC) strategy from clinical development to
commercialization. CMC can often become a rate-limiting step due to
lack of knowledge and lack of a formal policy or guidelines on CMC
for peptide-based drugs. Regulators use a risk-based approach,
reviewing applications on a case-by-case basis. Peptide
Therapeutics: Strategy and Tactics for Chemistry, Manufacturing,
and Controls covers efficient manufacturing of peptide drug
substances, a review of the process for submitting applications to
the regulatory authority for drug approval, a holistic approach for
quality attributes and quality control from a regulatory
perspective, emerging analytical tools for the characterisation of
impurities, and the assessment of stability. This book is an
essential reference work for students and researchers, in both
academia and industry, with an interest in learning about CMC, and
facilitating development and manufacture of peptide-based drugs.
Implantable technologies allow for a sustained control over the
release of pharmaceuticals into the bloodstream thereby achieving a
controlled concentration with the potential to minimise
side-effects while increasing patient compliance. Significant
progress has been made in various alternative implantable delivery
technologies, notably in intraocular and subcutaneous devices.
Despite success in research and clinical studies, long-term
clinical efficacy may be more limited and different aspects related
to drug development and commercialization using these technologies
are not well understood or practiced in the commercial setting.
This book provides a comprehensive and cohesive picture of the
latest in the field while also outlining the opportunities and
challenges in implantable technology. Implantable Technologies:
Pepties and Biologic Drug Development is an ideal reference for any
postgraduate or researcher interested in utilising implantable
technologies and novel routes of drug administration. The book will
also be of interest to those involved in formulation and clinical
application for a wide array of disease areas in addition to more
established paradigms such as diabetes and pain management.
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