Portada

CLINICAL RESEARCH IBD

PHARMAMED PRESS
04 / 2023
9789389974447
Inglés

Sinopsis

·áááááááComprehensive content covering all aspects of clinical research.·áááááááEvolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.·áááááááMilestones in the evolution of drug regulations in India·áááááááDrug regulatory framework in India and key ICH countries.·áááááááEvolution of drug pricing mechanisms and IPRs in India.·ááááUpdated 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.·áááááááLatest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.·ááááTemplates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.

PVP
107,05