Pharmaceutical medicine and translational clinical research / edited by Divya Vohora, Gursharan Singh.

Format:

Book

Contributor:

Vohora, Divya, editor.

Singh, Gursharan, editor.

Language:

English

Subjects (All):

Clinical medicine--Research.

Clinical medicine.

Physical Description:

1 online resource (498 pages) : illustrations

Edition:

1st ed.

Place of Publication:

London, England : Academic Press, 2018.

Summary:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.- Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and- Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Contents:

The speciality of pharmaceutical medicine / Gerfried K.H. Nell

Drug discovery and development / Sandeep Sinha and Divya Vohora

Pharmaceutical development / Harinder Singh, Lalit K. Khurana, and Romi Singh

Preclinical drug development / Gusharan Singh

Target product profile / Gusharan Singh

Clinical pharmacokinetics and drug interaction / Nilanjan Saha

Pharmacogenomics / Ankit Srivastava, Debleena Guin, Ritushree Kukreti, and Divya Vohora

Clinical research quality assurance and audits / Geeta O. Bedi

Pharmaceutical medicine and law / Gusharan Singh

Pharmaceutical regulations in the United States / Sunita Narang

Pharmaceutical regulations in European Union / Bharti Khanna

Pharmaceutical regulations in India / Nidhi B. Agarwal and Manoj Karwa

Pharmaceutical regulations for complementary medicine / Preeti Vyas and Divya Vohora

Ethical considerations in clinical research / Divya Vohora

Patent / Bindu Sharma

Copyright / Bindu Sharma

Trademark / Bindu Sharma

Trade secret / Bindo Sharma

Data exclusivity / Gursharan Singh

Generic drug and bioequivalence studies / Rajinder K. Jalali and Deepa Rasaily

Vaccines / Subodh Bhardwaj

Biosimilars / Gursharan Singh

Re-innovation in pharmaceutical industry / Gusharan Singh

Phase IV studies and lifecycle management / Gerfried K.H. Nell

Medical affairs / Gerfried K.H. Nell

Pharmacovigilance and drug safety / Rajinder K. Jalali

Clinical and post approval safety data management / Rajinder K. Jalali

Individual case safety reports / Rajinder K. Jalali

Development and periodic safety reports / Rajinder K. Jalali

Risk management in pharmacovigilance / Rajinder K. Jalali

Recent developments in pharmacovigilance at UMC / Sten Olsson

Tools for assessing and monitoring medicine use / Sangeeta Sharma

Pharmacoeconomics in healthcare / Mahendra Rai and Richa Goyal.

Notes:

Includes bibliographical references and index.

Description based on online resource; title from PDF title page (EBC, viewed December 4, 2017).

ISBN:

0-12-802098-9

0-12-802103-9