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The aim of this book entitled "Ethical Guideline on Paediatric Drug
Development; Regulatory Aspects" is to produce an informative and
readable collection of 12 short chapters that providing almost all
you wanted to know about Principles and Practice of Paediatric
clinical trial. The Author hope the book would be a potential
source of great pleasure to readers. Inside you'll find- Is
Clinical Trial Right for A Child, Foundation of Paediatric Clinical
Research, Ethical Conduct of Paediatric Clinical Studies,
Principles and Practice of Paediatric clinical trial, Paediatric
legislation and health authorities, Paediatric Drug Development,
Ethical & Regulatory issues and challenges with Paediatric
Subjects, Assent process and Parental permission of Paediatric
subject, The Child As Vulnerable patient (Protection And
Empowerment), PIP, Reviewing and Reporting Unanticipated Problems,
involving Risk to Paediatric Subjects or Associated Adverse Events
(ADRs/ AEs/ SAEs/ SUSAR), Post Marketing Surveillance studies
(Phase 4) of medicines used by paediatric population -Dr. Mahendra
Singh Ashawat Ph.D (M.Pharm), Nilima Kanwar Hada B.Pharm, PGDACR
(Clinical Research)
In last few decades interest of researcher and peoples were
augmented in cosmetics. Harmful effect of chemicals used in
cosmetic preparation gives rise to herbal products in cosmetology.
Unlike chemical based products, herbs are by nature more friendly
to human body and therefore are completely safe, extremely
effective and have almost no negative side effects. They are used
in cosmetic for enhancing attractiveness and cleaning purpose.
Beside this the standardization of the herbs and quality control of
the herbs are very necessary in the cosmetic. Hence the book
focuses on the potential of herbal extract for cosmetic purpose.
More sophisticated formulation containing herbal extracts are
expected to appear in the future as cosmetic and various challenges
which may affect quality of herbal products. It also enlightens
various compendia's standardization techniques which effectively
control the quality of herbal cosmetics.
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