Transforming Healthcare Research: The Evolution of Ethical Standards
Introduction The Ethical Standards and practices in the pharmaceutical and healthcare domains have undergone significant…
Regulatory Affairs: Roles, Responsibilities & Significance
Regulatory affairs is a function that plays a vital role throughout a product's lifecycle and serves as a liaison between the industry and regulatory bodies.
Unlock Product Development with the Inactive Ingredient Database (IIG)
Introduction The Inactive Ingredient Database (IIG) is a powerful resource for pharmaceutical development, providing valuable…
From Idea to Impact: The Ultimate Guide to New Product Development
The drug development process is intricate and must ensure quality, safety, efficacy, and compliance, typically taking 12-15 years and costing around $1 billion. It includes five stages: discovery and development, non-clinical development, clinical development, regulatory review, and post-marketing surveillance. Key phases such as Phase 0, I, II, and III assess safety, tolerability, efficacy, and effectiveness in humans before market approval. Regulatory bodies oversee these stages to ensure public health while ongoing Phase IV trials monitor long-term safety and effectiveness post-approval.