Drug Products For Clinical Trials

<P>Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this second edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation and quality and regulatory control of clinical trial materials.</P> <P>Tracking emerging trends and the development of new technologies, the text:</P> <UL> <LI>helps the CTMP operate effectively in the international sphere and reviews regulatory processes for drug approvals in the United States and Europe </LI> <LI>discusses the role of the CTMP in the shepherding of a new medicament from inception to market </LI> <LI>highlights the need for CTMPs to acquire contemporary knowledge of the rapidly evolving clinical trial process </LI> <LI>provides a chapter on facilities design and utilization for the production of potent and hazardous products - describing a classification system for potent compounds and containment practices for all manufacturing scales</LI> <LI>covers the manufacturing and control practices necessary to produce blinded products - treating all varieties of dosage forms such as solids, liquids, injectable products, creams and ointments</LI> <LI>contains a complete survey of inhalation products - including pre-formulation and formulation concerns and comparisons of various inhalation products </LI> <LI>includes step-by-step discussion of packaging and labeling protocols </LI> <LI>presents systematic approaches to define and develop working agreements for the most effective return of deliverables form outsourced work. </LI></UL> <P>With an authoritative selection of chapters by esteemed researchers and consultants in industry, this is undoubtedly a key work in its field.</P>
ISBN: 978-0-8247-5462-4

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