Abstract
Aim: The aim of present project work is to understand the guidelines and regulatory requirements for investigational new drug and development of new drug Objectives: The objective of current project include Need of a new drug to investigate New drug development targets Understanding the properties of new dug Required protocols for submission of new drug to regulatory authority Regulatory requirements to get approval of new drug.
Highlights
Definition of an Investigational ProductICH Good Clinical Practice (GCP) defines an investigational product as, “A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial” (ICH GCP 1.33)
The Code of Federal Regulations (CFR) defines an investigational new drug as: "...a new drug or biological drug that is used in a clinical investigation." In the U.S Food and Drug Administration (FDA) regulations, an investigational new drug is any substance for which FDA approval is being sought
ICH GCP refers to an Investigational Product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
Summary
ICH GCP defines an investigational product as, “A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial” (ICH GCP 1.33). This may include a marketed product that is being used in a different form than the one it was approved for, or a marketed product being used for an unapproved or new indication. Drug discovery is a process, which aims at identifying a compound therapeutically useful in treating and curing a disease. Drug discovery and development is an expensive process due to the high costs of R&D and human clinical tests.
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