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Where? (Paperback)
Jordan Collins; Illustrated by Phil Lesnie
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R233
R194
Discovery Miles 1 940
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'Where are you from?' they say. What they mean is, 'Why is your
skin that colour?' 'Why does your hair look like that?' I am from
the mountains, The seas and the sky. I am from children of millions
of years, A timeline of humanity. I am from this planet And all
others. A heartfelt picture book that challenges racism from an
exciting new voice that is both a cry of pain and a demonstration
of inner strength, which takes us on an intergalactic journey past
collapsing stars and glowing nebulae to remind us not of our
differences but of our shared humanity.
Currently there are no process validation (PV) textbooks addressing
the lifecycle concepts (Stage 1, 2, 3). Recent regulatory
guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH
lifecycle approach. The concepts are now harmonized across
regulatory guidance's and organizations have an opportunity to
align PV activities for all regulated markets. Therefore a need
exists for consensus and direction on how to approach solid dose
manufacturing process validation for regulatory compliance. Solid
Dose Process Validation: The Basics, Volume One and companion Solid
Dose Process Validation: Lifecycle Approach Application, Volume
Two, also available as a set, provide directions and solutions for
these unmet needs for the pharmaceutical industry. The topics and
chapters give a systematic understanding for the application of
lifecycle concepts in solid dose pharmaceutical manufacturing. All
approaches meet the regulatory requirements enlisted in the
guidance's, which is the precursor to applying the concepts. This
set is published as a comprehensive solution for solid dose process
validation. Since solid dose formulations encompass majority of the
pharmaceutical preparations, it is essential information for
pharmaceutical professionals who use the process validation
lifecycle approach.
The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of
Process Validation. Regulatory bodies such as US FDA, EMEA, WHO,
PIC/S have adopted the ICH lifecycle approach. Organizations have
an opportunity to harmonize and align PV activities for all
regulated markets. The concepts discussed provides a direction on
how to approach solid dose manufacturing process validation for
regulatory compliance. Solid Oral Dose Process Validation,
Lifecycle Approach: Application, Volume Two and the companion
Volume One, Solid Dose Process Validation, The Basics, also
available as a set, provide directions and solutions for the
pharmaceutical industry. The topics and chapters give a systematic
understanding for the application of lifecycle concepts in solid
dose pharmaceutical manufacturing. Since solid dose formulations
encompass majority of the pharmaceutical preparations, it is
essential information for pharmaceutical professionals who use the
process validation lifecycle approach. This set is published as a
comprehensive solution for solid dose process validation.
This work traces the development of the theory of types from its
origins in the early 20th century through its various forms until
the mid 1950s. Attention is paid to the reception of this theory
after the publication of the second edition of Whitehead and
Russell's 'Principia Mathematica'. I examine the decline of the
theory over four decades, focusing on its modification by logicians
such as Ramsey, Carnap, Church, Quine, Godel, and Tarski. Finally,
the view of the theory of types as a many-sorted first-order theory
is discussed. It is shown that a revival of the ramified theory of
types in the 1950s coincided with the consideration of cumulative
type hierarchies which substantially altered the form of the
theory. The theory was altered even more drastically in its change
from a many-sorted theory to a one-sorted theory. This final
'standardization' made it not much different from first-order
Zermelo-Fraenkel set-theory. The theory of types, whose
developments are traced in this work, therefore lost its prominence
as the foundation for mathematics and logic. This historical
analysis will be of interest primarily to those working in the
History and Philosophy of Mathematics."
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