This reference book from Jaypee Brothers Medical Publishers is an English medium (अंग्रेजी माध्यम) book on drug discovery and clinical research, edited by SK Gupta and Sushma Srivastava with contributions from specialists in the field, prepared for postgraduate students of pharmacology and pharmacy, clinical research professionals, investigators, medical writers and regulatory affairs personnel, and also useful for MBBS students who wish to understand how a drug reaches the market. This Second Edition follows a molecule through its whole journey — from target identification and lead optimisation in the laboratory, through preclinical toxicology and pharmacokinetic screening, into the phases of human trials, and finally to marketing approval and post-marketing surveillance — with the regulatory and ethical framework (नैतिक ढाँचा) governing each step set out alongside. The book covers drug discovery approaches and target-based screening, preclinical evaluation and animal toxicity studies, investigational new drug applications, the design and conduct of Phase I to Phase IV clinical trials, bioavailability and bioequivalence studies, randomisation, blinding and biostatistics in trial design, Good Clinical Practice and ICH guidelines, the roles of the investigator, sponsor and contract research organisation, ethics committees and informed consent, clinical data management and documentation, pharmacovigilance and adverse event reporting, regulatory requirements in India including the CDSCO framework and international regulations, and the special considerations of trials in vulnerable populations and of biologics and biosimilars. Its distinguishing feature is this end-to-end coverage written in the Indian regulatory context by contributors working in the field. All content, terminology and explanations in this book are presented in the English language only.
Key Features:
English medium book — complete content, terminology and explanations in English
Edited by SK Gupta and Sushma Srivastava, published by Jaypee Brothers Medical Publishers
Second Edition, revised and updated
Multi-contributor reference written by specialists in drug development and clinical research
Covers the complete path from molecule discovery to post-marketing surveillance
Indian regulatory framework covered alongside international guidelines
Written for pharmacology and pharmacy postgraduates, clinical research professionals and regulatory personnel
Also useful for MBBS students and investigators new to clinical trials
Diagrams, flowcharts and tables for quick reference
Drug discovery approaches, target identification and lead optimisation
Preclinical evaluation, animal toxicity and pharmacokinetic screening
Investigational new drug application and approval process
Design and conduct of Phase I, II, III and IV clinical trials
Bioavailability and bioequivalence studies
Randomisation, blinding and biostatistics in clinical trial design
Good Clinical Practice (GCP) and ICH guidelines
Roles of investigator, sponsor and contract research organisation
Ethics committees, informed consent and protection of trial subjects
Clinical data management, documentation and audit
Pharmacovigilance, adverse event reporting and risk management
Regulatory requirements in India including the CDSCO framework
Trials in vulnerable populations, and biologics and biosimilars
Useful for postgraduate examinations, dissertation work and professional practice in clinical research
Pharmacology एवं Pharmacy के स्नातकोत्तर विद्यार्थियों, clinical research professionals, investigators तथा regulatory affairs कर्मियों के लिए Jaypee Brothers Medical Publishers द्वारा प्रकाशित यह "Drug Discovery & Clinical Research" (2nd Edition) पुस्तक SK Gupta एवं Sushma Srivastava द्वारा संपादित है; यह MBBS विद्यार्थियों के लिए भी उपयोगी है। इसमें drug discovery एवं target-based screening, preclinical मूल्यांकन एवं toxicity अध्ययन, IND आवेदन, Phase I से IV तक clinical trials का डिज़ाइन एवं संचालन, bioavailability व bioequivalence, randomisation एवं biostatistics, Good Clinical Practice एवं ICH गाइडलाइंस, नैतिकता समिति एवं informed consent, clinical data management, pharmacovigilance तथा भारत के CDSCO सहित नियामक आवश्यकताओं को चित्रों, फ्लोचार्ट्स एवं तालिकाओं सहित समझाया गया है। सम्पूर्ण पुस्तक अंग्रेजी माध्यम (English medium) में है, इसमें हिंदी माध्यम की सामग्री सम्मिलित नहीं है।
