Related Experiment Video
Updated: Feb 14, 2026
05:02
Comparing Bibliometric Analysis Using PubMed, Scopus, and Web of Science Databases
Published on: October 24, 2019
33.9K
Indian Regulatory Update: January-December 2017
1Department of Regulatory Affairs, Global Drug Development India, Novartis India Limited, Mumbai, Maharashtra, India.
Perspectives in Clinical Research
|February 13, 2018
Summary
This document details updated regulatory requirements for conducting clinical trials in India. Stay informed on the latest compliance guidelines for research in the Indian regulatory landscape.
Area of Science:
- Regulatory Affairs
- Clinical Research Management
Background:
- Clinical trials are crucial for medical advancement.
- Navigating regulatory requirements is essential for trial success.
Purpose of the Study:
- To inform stakeholders about recent changes in clinical trial regulations in India.
- To ensure compliance with updated Indian regulatory standards.
Main Methods:
- Review of official regulatory documents and announcements.
- Analysis of changes impacting clinical trial conduct.
Main Results:
- Key updates to the regulatory framework for clinical trials in India have been identified.
- Specific changes affecting trial protocols, ethics, and data management are outlined.
Conclusions:
- Adherence to updated regulations is mandatory for all clinical trials in India.
- Stakeholders must familiarize themselves with these changes to maintain compliance and ethical standards.
Related Concept Videos
02:02Cis-regulatory Sequences
11.9K
Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...
11.9K
02:02Cis-regulatory Sequences
4.2K
4.2K
01:28Global Regulatory Systems
732
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
732
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
15
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
15
01:03Drug Control Governance: Regulatory Bodies and Their Impact
573
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
573
01:52Eukaryotic Transcription Inhibitors
11.1K
Certain biochemical processes, such as embryonic development and cell growth regulation, depend on the repression of specific genes. DNA binding proteins known as eukaryotic transcription inhibitors regulate the repression of gene expression in eukaryotes. The presence of these inhibitors at the required location and time in the cell is triggered by the presence of hormones and additional signals from other cells.
Eukaryotic transcription inhibitors usually contain two distinct domains, a...
Eukaryotic transcription inhibitors usually contain two distinct domains, a...
11.1K