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The Medical Writer

In "The Medical Writer," I describe the journey of how new medications are created, starting from the initial discovery to the final approval. If you’re interested in how treatments change from concept to reality, you’ve come to the right spot. Let's work together to make this scientific research both understandable and enjoyable.

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REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY

REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY Investigational New Drug Application (IND) It is an application from a clinical research sponsor to the Food and Drug Administration (FDA) for authorization for administering an investigational drug to humans. INDs are classified into three types: An investigator IND is submitted by a physician who begins and investigates the clinical trial drug and manages its administration or dispensing. Emergency Use IND allows the FDA to authorize the use of an investigational drug in an emergency situation that does not allow for the submission of an IND in compliance with 21 CFR. Treatment INDs are submitted for investigational drugs that show promise in clinical testing for serious life-threatening illnesses. IND applications must include information in three broad areas: Animal Pharmacology and Toxicology Studies Manufacturing Information Clinical Protocols and Investigator Information Three Important Componates of IND Once the IND is sub...

THE STAGES OF DRUG DISCOVERY AND DEVELOPMENT

THE STAGES OF DRUG DISCOVERY AND DEVELOPMENT Drug discovery aims to identify compounds that are therapeutically useful in the treatment of diseases. This procedure involves choosing candidates, synthesizing, characterizing, validating, optimizing, screening, and performing therapeutic efficacy tests. Once a compound has shown significance in these investigations, it will initiate the drug development process earlier in clinical trials. The new medication development process must go through multiple steps to produce a medicine that is safe, effective, and meets all regulatory standards. From initial discovery to marketable medicine, this is a long, challenging task. It takes about 12 to 15 years to complete. · Identification of unmet medical needs · Target identification · Target validation · ...

INVESTIGATOR'S BROCHURE IN CLINICAL TRIALS

INVESTIGATOR'S BROCHURE IN CLINICAL TRIALS The Investigator's Brochure (IB) serves as a resource for clinical trial investigators. It highlights the key components of a product's development to date. It reviews nonclinical and clinical findings. It suggests ways to study the new product's benefits and dangers. Regulatory Guidance on Structure and Content Section 7 of ICH E6 lists the highest-level sections as follows: Summary Introduction Physical, chemical, and pharmaceutical properties and formulation Non-clinical studies Effects in humans Summary of data and investigator instructions. When researchers conduct the first human clinical trial, they require an IB. According to ICH E6, a team should review an IB at least once a year and revise it when necessary. However, the team may increase the frequency of revisions based on the development stage and new relevant information. The Six Main Sections of an IB Summary This part summarizes the next sections. It profil...

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