<b><u>About the Book:</u></b><br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Comprehensive content covering all aspects of clinical research.<br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.<br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Milestones in the evolution of drug regulations in India<br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Drug regulatory framework in India and key ICH countries.<br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Evolution of drug pricing mechanisms and IPRs in India.<br />&middot;&nbsp; &nbsp; &nbsp; &nbsp;Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017.<br />&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.<br />&middot;&nbsp; &nbsp; &nbsp; &nbsp;Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.<br /><b><u>Contents:</u></b><br /><b>Section &ndash; A - Drug Development: Recent Advances</b><br /><b>1.&nbsp;&nbsp;&nbsp;&nbsp;</b>Newer Paradigms in Drug Development<br /><b>Section &ndash; B - Drug Regulations: International Scenario</b><br /><b>2.&nbsp;</b>International Drug Regulations<br /><b>Section &ndash; C - Drug Regulations: Indian Scenario</b><br /><b>3.&nbsp;</b>Evolution of Drug Regulations in India<br /><b>4.&nbsp;</b>Drug Regulatory Framework in India<br /><b>5.&nbsp;</b>Drug Approval Process in India<br /><b>Section &ndash; D - Drug Regulations: Specialized Areas of Clinical Research</b><br /><b>6.&nbsp;</b>Clinical Research on Biologics<br /><b>7.&nbsp;</b>Clinical Research on Traditional Medicine<br /><b>8.&nbsp;</b>Clinical Research on Medical Devices<br /><b>9.&nbsp;</b>Clinical Research on Stem Cells<br /><b>10.&nbsp;</b>Clinical Research in Special Populations<br /><b>11.&nbsp;</b>Bioavailability and Bioequivalence Studies<br /><b>Section &ndash; E - Clinical Research: Ethical Considerations</b><br /><b>12.&nbsp;</b>Evolution of Ethics in Research<br /><b>13.&nbsp;</b>Ethical Principles and Issues in Research<br /><b>14.&nbsp;</b>Ethics Committee<br /><b>15.&nbsp;</b>Informed Consent<br /><b>16.&nbsp;</b>Compensation Issues in Clinical Trials<br /><b>Section &ndash; F - Clinical Research: An Overview</b><br /><b>17.&nbsp;</b>Types and Principles of Clinical Research<br /><b>Section &ndash; G - Clinical Trials: Methodological Aspects</b><br /><b>18.&nbsp;</b>Good Clinical Practice<br /><b>19.&nbsp;</b>Practical Considerations in Designing and Conducting Clinical Trials<br /><b>20.&nbsp;</b>Designs used in Clinical Trials<br /><b>21.&nbsp;</b>Randomization<br /><b>22.&nbsp;</b>Blinding<br /><b>23.&nbsp;</b>Bias<br /><b>24.&nbsp;</b>Compliance in Clinical Trials<br /><b>25.&nbsp;</b>Clinical Trial Monitoring<br /><b>26.&nbsp;</b>Data and Safety Monitoring Boards<br /><b>27.&nbsp;</b>Clinical Data Management<br /><b>28.&nbsp;</b>Case Report Form<br /><b>29.&nbsp;</b>Quality Management in Clinical Research<br /><b>30.&nbsp;</b>Biomarkers<br /><b>31.&nbsp;</b>Multicentric Clinical Trials<br /><b>Section &ndash; H - Clinical Drug Development: Premarketing Phases</b><br /><b>32.&nbsp;</b>Phase Zero Clinical Trials<br />&nbsp;