Drug approval - PowerPoint PPT Presentation


Strategic Differentiation for a New Drug in a Crowded Market

We, at Jasper Colin, stepped in to help them create a strategic positioning for their new drug, ensuring it stood out in a competitive landscape. Our strategic positioning efforts gave the drug a competitive edge, making it a preferred choice among European physicians.\n\nRead the full report to div

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Understanding Graded Dose-Response Relationships in Pharmacodynamics

Graded dose-response relationships in pharmacodynamics involve how drug effects depend on concentrations at receptor sites. The potency and efficacy of drugs can be determined through these relationships. Potency refers to the amount of drug needed for a specific effect, while efficacy relates to th

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Air Force Drug Demand Reduction Program Overview

This document provides insights into the Air Force Drug Demand Reduction Program's objectives, governing directives, testing procedures, and the mission to maintain a drug-free environment. It highlights the various types of drug testing, commander roles, and the program's commitment to safeguarding

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Age-Friendly App: Managing Drug-Drug Interactions Between Prescriptions and OTC Analgesics

The Age-Friendly app addresses the crucial issue of drug-drug interactions between current prescriptions and over-the-counter analgesics in the geriatric population. With a significant percentage of OTC sales attributed to older adults, there is an increased risk of adverse drug events due to polyph

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Long-Acting Injectable Peptide-Like Hydrogel for Sustained Drug Delivery

Injectable peptide-like hydrogels offer a novel approach for sustained drug delivery over extended periods. This technology, developed by Dr. Garry Laverty, aims to improve patient adherence by providing a convenient and effective long-acting formulation. The hydrogel, formed in situ, allows for sus

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Understanding Regulatory Requirements of Drugs and Pharmaceuticals

Drug regulation involves controlling drug use through international agreement authorities like the FDA, EMA, and PMDA. The FDA plays a crucial role in drug evaluation and research, biologic evaluation, devices, and food safety. There are various types of applications for drug approval, along with a

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Understanding the NDA and ANDA Regulatory Approval Process

The New Drug Application (NDA) submission process to the FDA involves extensive documentation of non-clinical, clinical, and drug chemistry data to support the product's labeling. Key decisions during the FDA review include evaluating the drug's safety, effectiveness, labeling, manufacturing methods

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Polymeric Controlled Drug Delivery Systems

Polymeric controlled drug delivery systems play a crucial role in regulating drug release through diffusion, solvent penetration, and chemical mechanisms. These systems include diffusion-controlled, solvent-controlled, and chemically-controlled devices, each operating based on specific principles. S

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Renal Pharmacology: Drug Excretion and Renal Clearance Questions

This comprehensive set of questions and answers covers topics related to drug excretion and renal pharmacology. It includes information on glomerular filtration, drug excretion mechanisms, dosage adjustments in renal impairment, factors influencing drug excretion, and the effects of long-term NSAID

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Understanding Nasopulmonary Drug Delivery System

Nasopulmonary drug delivery system, utilizing the nasal route for drug administration, offers advantages such as hepatic first-pass metabolism avoidance and rapid drug absorption. This system is beneficial for pharmacologically active compounds with poor stability in gastrointestinal fluids. While i

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Understanding Physicochemical Properties of Drugs

The physicochemical properties of drugs play a crucial role in their pharmacological effects. These properties include physical and chemical characteristics that influence interactions with biomolecules. Solubility, partition coefficient, and dissociation constant are key factors affecting drug beha

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Overview of Central Drug Standard Control Organisation (CDSCO) in India

The Central Drug Standard Control Organisation (CDSCO) is the main regulatory body in India for pharmaceuticals, medical devices, and clinical trials. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. The CDSCO is responsible f

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Understanding Formulary Systems in Healthcare

A formulary is a dynamic list of medications curated by healthcare professionals to guide drug selection based on efficacy, safety, cost, and patient acceptability. It plays a vital role in promoting evidence-based and cost-effective drug therapy, improving communication between prescribers and phar

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Ways to Stay Drug Free: Lessons for Teens and Families

Understanding the reasons behind drug usage among teens, this lesson provides valuable resources and strategies to stay drug-free. It emphasizes the importance of making healthy decisions and offers alternatives to drug use. Additionally, it highlights the significance of saying no to drugs, provide

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Understanding the Hatch-Waxman Act: Promoting Affordable Generic Drugs

The Hatch-Waxman Act, also known as The Drug Price Competition and Patent Term Restoration Act, was enacted in 1984 to amend patent laws and the Federal Food, Drug, and Cosmetic Act. It aims to reduce costs associated with generic drug approval, allow early experimental use, compensate branded drug

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Understanding Biopharmaceutics: pH Partition Theory and Drug Absorption

Biopharmaceutics explores how drug properties and administration methods impact drug absorption. Factors affecting oral absorption include membrane physiology and drug partitioning based on pH levels. The pH partition theory, explained by Brodie et al., highlights the role of drug lipid solubility a

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Importance of In-Vitro Dissolution Testing in Drug Assessment

In drug development, in-vitro dissolution testing plays a crucial role in evaluating drug release from tablets when in-vivo bioavailability studies are limited. By ensuring drug release is close to 100% and uniform batch to batch, these tests help assess drug availability and effectiveness. Regulato

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Understanding Pharmacodynamics: Potency and Efficacy

Pharmacodynamics explores how drugs interact with receptors in the body, affecting the magnitude of drug effects based on concentration. Graded dose-response relationships, potency, and efficacy play key roles in determining drug efficiency. Potency reflects the amount of drug needed for a specific

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Understanding Drug Absorption, Excretion, and Bioavailability in Humans

Delve into the complex processes of drug absorption, excretion, and bioavailability in the human body. Learn about the various factors affecting drug absorption from the gastrointestinal tract, including biological, physiochemical, and pharmaceutical factors. Explore the mechanisms of drug transport

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Understanding Quantitative Aspects of Drug Action

Explore the quantitative aspects of drug action, including drug receptor binding, concentration binding curves, dose-response curves, and types of antagonism. Learn to relate drug concentration to receptor binding capacity and response produced. Discover how concentration binding curves and dose-res

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Understanding IVIVC in Pharmaceutical Sciences

In the field of pharmaceutical sciences, In Vitro-In Vivo Correlation (IVIVC) plays a crucial role in predicting the relationship between in vitro dissolution rates of drug dosage forms and in vivo absorption rates. This correlation is essential for bioequivalence studies, reducing the number of tri

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Review of DRE School and Drug Evaluation Techniques

Explore key topics such as the definition of drugs for DRE purposes, basic drug statistics, review of symptomatology, and vital signs assessment in the context of Drug Recognition Expert (DRE) training. Learn about CNS depressants, stimulants, hallucinogens, and analogs, as well as vital signs like

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Study on Juvenile Drug Crime Prevention in Taiwan: Insights from ACS Conference 2020

This presentation at the Asian Criminological Society Conference 2020 delves into the current situation, dilemmas, and responses regarding juvenile drug crime prevention in Taiwan. The presenter, Zeng Li-Wen, a PhD student at Central Police University in Taiwan, provides valuable insights based on t

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Comprehensive Guide to CTE Program Approval Process

A detailed guide covering the CTE program approval process, deadlines, components of an approved CTE program of study, CIP code and program name significance, data approval applications, and self-study form requirements. It explains the application deadlines, consequences of missing documentation, l

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Understanding Drug Abuse: Definitions, Effects, and Stages

Drug abuse is a serious issue involving various substances like prescription drugs, alcohol, and illegal drugs. This includes terms and definitions, effects on the body and mind, stages of addiction, and withdrawal symptoms. Factors influencing drug action and reasons for drug use are also explored.

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Understanding Drug Targets and Mechanisms of Action

Explore the intricate world of pharmacokinetics and pharmacodynamics, from drug absorption to their interaction with biological molecules. Learn about different drug targets, such as proteins and ions, and how drugs alter their biochemical and biophysical activities. Dive into molecular mechanisms o

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International Day Against Drug Abuse and Illicit Trafficking 2022 Initiatives and Awareness

The United Nations observes 26th June as the International Day Against Drug Abuse and Illicit Trafficking to combat substance abuse worldwide. Various initiatives like the National Drug Master Plan, Nasha Mukt Bharat Abhiyaan, and the National Action Plan for Drug Demand Reduction aim to raise aware

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Comprehensive Review of Drugs, Categories, and Drug Influence Evaluation

This mid-course review covers key aspects such as defining drugs, naming drug categories and subcategories, identifying drug categories for specific drugs, components of drug influence evaluation, and examinations conducted as part of the evaluation process. The content also includes identifying dru

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Evolution of Oncology Drug Development Strategies

Explore the shifting trends in oncology drug development, from understanding cancer mechanisms to new immuno-oncology approaches. Delve into the role of statisticians in researching cancer drugs and uncover the importance of early-phase trials in validating treatment mechanisms. Discover the need fo

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Impact of Socioeconomic Conditions on Drug Use Disorders: Insights from World Drug Report 2020

The World Drug Report 2020 highlights the strong correlation between socioeconomic factors and drug use disorders. Studies reveal that communities facing poverty, violence, and social inequality are at a higher risk of drug overdoses and addiction. Factors like income inequality, lack of social capi

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Professional Development Information & Approval Process Guidelines

Guidelines for professional development approval process from January to June 2015 include maximizing staff presence, prioritizing PD activities, determining criteria for mandatory PDs, and steps to follow for approval. The process involves rescheduling events, using specific criteria, and submittin

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Understanding Targeted Clinical Investigation in Pharmacovigilance

Targeted clinical investigation plays a crucial role in pharmacovigilance by further evaluating significant risks identified in pre-approval clinical trials. This involves conducting pharmacokinetic and pharmacodynamic studies, genetic testing, interaction studies, and large simplified trials to ass

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Facilitating Development of Innovative Drug Formulations and Delivery Mechanisms: The Role of Medicines Patent Pool

The presentation by Charles Gore, Executive Director of Medicines Patent Pool, at IAS 2019 discussed how the MPP works to ensure future access to innovative drug formulations and delivery mechanisms. The MPP model involves negotiating public health-driven licenses with patent holders, sublicensing t

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Advances in Ophthalmic Drug Delivery Systems

This content explores various advanced ophthalmic drug delivery systems including erodible ophthalmic inserts, soluble ocular drug inserts, new ophthalmic drug delivery systems, and bioadhesive ophthalmic drug inserts. These innovative systems aim to provide accurate dosing, prolonged drug release,

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State Responsible Inmates with Marijuana Convictions Research Report

Research conducted by VADOC indicates a total of 570 state responsible inmates incarcerated for marijuana-related offenses as of August 31, 2021. Among them, 229 inmates had non-drug-related Most Serious Offenses, 331 were convicted for Drug Sales MSO, and 10 were convicted for Drug Possession MSO.

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Approval Frameworks and Forms for Academic Programs by Tamara Ferry, Ph.D.

A comprehensive guide on approval frameworks and forms for academic programs, addressing the fragmented and isolated historical practices. It includes four essential frameworks for proposing new programs, making changes to existing programs, creating professional development proposals, and discontin

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Innovative Online Learning for Drug Court Professionals

Center for Court Innovation has introduced a new National Drug Court Online Learning System aimed at assisting drug court professionals. This system offers free access to web-based training, expert video lessons, virtual site visits to drug treatment courts, practitioner interviews, and a resource l

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Understanding Drug Testing Policies in the Workplace

The Drug-Free Workplace Act of 1988 mandates federal grant recipients to implement zero-tolerance drug policies to maintain a drug-free environment. Employers must establish clear policies, conduct awareness programs, offer counseling and rehabilitation services, and impose penalties for violations.

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Understanding the Animal Rule in Drug Approval Process

The Animal Rule addresses the approval of new drugs when human efficacy studies are not possible. It serves as a surrogate for human studies, requiring well-controlled animal testing to predict clinical benefits in humans. Safety must still be demonstrated in human trials, and the rule can be bypass

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Understanding Azole Therapeutic Drug Monitoring for Antifungal Therapy

Azole therapeutic drug monitoring (TDM) is crucial for managing antifungal therapy due to factors like drug interactions, compliance issues, disease severity, and pharmacokinetic variability. This monitoring helps ensure optimal drug levels are maintained for effective treatment. Different TDM metho

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