· Comprehensive content covering all aspects of clinical research. · Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc. · Milestones in the evolution of drug regulations in India · Drug regulatory framework in India and key ICH countries. · Evolution of drug pricing mechanisms and IPRs in India. · 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. · Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019. · Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.
| Autorius: | Niti Mittal, Bikash Medhi, |
| Leidėjas: | PharmaMed Press |
| Išleidimo metai: | 2023 |
| Knygos puslapių skaičius: | 508 |
| ISBN-10: | 9389974445 |
| ISBN-13: | 9789389974447 |
| Formatas: | 241 x 196 x 32 mm. Knyga kietu viršeliu |
| Kalba: | Anglų |
Parašykite atsiliepimą apie „Clinical Research: Principles, Practice and Perspective“
