Drug regulation - 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

4 views • 6 slides


Overview of EU Timber Regulation (EUTR) 995/2010 and its Application in Italy

The EU Timber Regulation (EUTR) 995/2010 aims to combat illegal timber trade by ensuring that timber placed on the European market is from legal sources. Applicable to most wood materials regardless of origin, the regulation requires due diligence in the timber supply chain. Italy implemented the re

2 views • 44 slides



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

0 views • 32 slides


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

0 views • 14 slides


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

1 views • 25 slides


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

0 views • 28 slides


Regulation of Extracellular Fluid Volume: A Comprehensive Overview

Understanding the intricate mechanisms involved in the regulation of extracellular fluid volume is essential for maintaining normal body function. This includes sensor and effector roles in renal regulation, the influence of aldosterone on Na+ reabsorption, the significance of Na+ balance, and the i

1 views • 22 slides


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

0 views • 33 slides


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

0 views • 55 slides


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

0 views • 35 slides


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

1 views • 46 slides


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

0 views • 17 slides


Overview of Central and State Drug Regulatory Bodies in India

Drug Regulatory Authority plays a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products in India. Governed by both Central and State Governments, key bodies such as CDSCO and DCGI regulate the importation, distribution, and promotion of drugs. Ministry of Health & Fam

0 views • 27 slides


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

0 views • 17 slides


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

0 views • 49 slides


Understanding the EU General Data Protection Regulation (EU GDPR)

The EU General Data Protection Regulation (EU GDPR) is a comprehensive regulation that governs the processing of personal data of individuals in the EU. It came into effect on May 25, 2018, and applies to all organizations handling personal data of EU residents. The regulation includes key definitio

4 views • 21 slides


Emerging Trends in Regulation and Credentialing for Advanced Practice Nursing

Explore the evolving landscape of regulation and credentialing in advanced practice nursing, including inconsistencies in titles, the debate between regulation and credentialing, and the challenges and purposes of regulation. Discover the impact on roles, education, and patient safety in this rapidl

0 views • 22 slides


Regulation of Blood Glucose and Its Importance in Maintaining Health

Blood glucose regulation is crucial for energy supply in the body, particularly for brain function. Understanding the balance of glucose entering and leaving the blood through processes like absorption, glycogenolysis, and gluconeogenesis is vital. Hormones like insulin and glucagon play key roles i

0 views • 10 slides


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

0 views • 9 slides


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

10 views • 10 slides


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

0 views • 21 slides


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

0 views • 24 slides


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

0 views • 29 slides


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

0 views • 29 slides


Drug Regulation Agencies and Functions in India

Drug regulation in India involves various agencies like CDSCO, ICMR, and NPPA to ensure the safety, efficacy, and quality of pharmaceutical drugs. Activities include product registration, quality control, and monitoring adverse drug reactions to protect public health.

0 views • 25 slides


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

0 views • 20 slides


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.

4 views • 45 slides


Regulation of Disinformation in the European Union: A Comprehensive Overview

The discussion covers the regulation of disinformation in the European Union, focusing on freedom of expression, legitimate restrictions on untruthful speech, media regulation provisions, and the code of practice on disinformation. It delves into key aspects such as hate speech, right of reply, regu

10 views • 15 slides


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

3 views • 17 slides


Enhancing Self-Regulation for Formative Assessment through Social and Emotional Learning

Explore the significance of self-regulation in formative assessment, understand key concepts like self-control, emotional competence, and perseverance. Discover actionable strategies to implement self-regulation interventions with students and train other adults effectively. Future orientation and s

0 views • 25 slides


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

3 views • 9 slides


Understanding Incentive Regulation in Utility Management

Incentive regulation in utility management involves various approaches such as Rate of Return Regulation (RORR), Price Cap Regulation, and Performance-based Regulation. Each method has its pros and cons, requiring careful consideration based on the specific setting. Rate hearings are essential quasi

0 views • 18 slides


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

0 views • 28 slides


Enhancing Self-Regulation Skills in Children: Strategies and Tips

Understanding and fostering self-regulation in children is crucial for their development. Self-regulation involves controlling impulses, focusing, and shifting between tasks. This article delves into the internal mechanisms of self-regulation, such as executive function, and provides practical tips

0 views • 22 slides


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

0 views • 17 slides


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

0 views • 12 slides


Quality Issues in Clinical Trial Materials: CMC Review by Dr. Dorota Matecka

Clinical trial materials undergo Chemistry, Manufacturing, and Controls (CMC) review to ensure pharmaceutical quality. This process includes assessing safety concerns, impurities, and specifications, along with other CMC considerations. Pharmaceutical quality encompasses the suitability, identity, s

0 views • 41 slides


Agricultural and Veterinary Chemicals Regulation in Australia - Overview

The regulation of agricultural and veterinary chemicals in Australia is overseen by the Australian Pesticides and Veterinary Medicines Authority (APVMA), established in 1993. The APVMA is responsible for assessing and registering pesticides and veterinary medicines to ensure their safety and effecti

0 views • 15 slides


Traffic Regulation Orders for Public Rights of Way in Essex

Traffic Regulation Orders (TROs) are essential for temporarily or permanently restricting public rights of way in Essex under the Road Traffic Regulation Act 1984. Temporary Traffic Regulation Orders (TTROs) are used for short-term restrictions due to works or safety reasons. The TTRO process involv

0 views • 15 slides


Regulation Proposal to Combat Deforestation and Forest Degradation in the European Union

The European Commission is proposing a regulation to prevent the entry and export of commodities linked to deforestation and forest degradation. This aligns with political commitments such as the European Green Deal and the Farm to Fork Strategy. Existing legislation like the FLEGT Regulation and th

0 views • 32 slides