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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
Litifilimab is an investigational drug being evaluated for the treatment of cutaneous lupus erythematosus and systemic lupus erythematosus. It is an anti- BDCA2 monocolonal antibody. [ 1 ] [ 2 ] [ 3 ]
MRTX1133 is an investigational drug that targets the G12D mutation in KRAS dependent cancers. [1] [2] It is currently in a phase 1/2 clinical trial for the treatment of solid tumors. [3] MRTX1133 is considered to be harmful from direct skin or eye exposure other than transient irritation. It may cause irritation of the respiratory system if ...
These are lists of investigational drugs: List of investigational analgesics; List of investigational antidepressants; List of investigational antipsychotics; List of investigational anxiolytics; List of investigational attention deficit hyperactivity disorder drugs; List of investigational autism and pervasive developmental disorder drugs
Islatravir (MK-8591), Merck’s investigational drug, is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for the treatment of HIV-1.
Enlicitide chloride (INN; [1] previously known as MK-0616) is a macrocyclic peptide investigational drug that is being evaluated for the treatment of hypercholesterolaemia. It is a PCSK9 inhibitor. [2] Merck has launched a Phase 3 clinical trial to evaluate the efficacy and safety of MK-0616 in Adults With Hypercholesterolemia. [3] [4]
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.