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Generic drug development involves identifying active ingredients, developing manufacturing processes, conducting clinical trials to test safety and efficacy, and obtaining regulatory approval. The process ensures generic drugs have the same active ingredients, dosage forms, quality, and intended use as brand-name drugs, allowing them to be used interchangeably at a lower cost since they do not require extensive research and development.
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ANDA -Abbreviated NewDrug Application.pptx
An Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug that is comparable to an existing brand-name drug in dosage form, strength, quality and intended use. An ANDA contains data demonstrating the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug may be marketed as a lower-cost alternative. The goal of the ANDA process is to expedite availability of affordable generic drugs while ensuring they are safe, effective and bioequivalent to the brand-name version.
Unit-I.pptx
This document discusses drug design and development. It begins by defining drug design as the process of finding new medications based on knowledge of a biological target. The drug is usually a small organic molecule that activates or inhibits a protein to produce therapeutic effects. It then discusses the different stages of drug development, including preclinical studies in vitro and in vivo, as well as clinical trials in four phases. Finally, it covers the concept and approval process for generic drugs, which must demonstrate bioequivalence to the brand name drug in order to receive FDA approval and be effectively substituted for the original.
Quality and formulation of medicines
This document discusses quality and formulation of medicines. It covers several topics:
1) Quality use of medicines includes selecting management options wisely based on the individual, condition, risks/benefits, and costs. It also involves using medicines safely and effectively.
2) Manufacturing of pharmaceutical products must follow good manufacturing practices to ensure quality, including production and quality control procedures.
3) Non-clinical safety studies are conducted on active substances and formulations to explore safety and inform clinical trials. Safety testing assesses margins of safety.
Fundamental of-product-development
This document discusses key aspects of product development for pharmaceutical products. It covers stages of product development including drug discovery, formulation development, process research and development, analytical research, toxicology testing, and clinical trials. It discusses important considerations for product design such as target product profiles, design specifications, commercial factors, technical risks, safety, intellectual property, and environmental impacts. Methods for testing drug-excipient compatibility like DSC, chromatography, and microscopy are also summarized. The importance of pilot plant scale up is discussed to help identify issues prior to full production.
Evaluation of public perception towards safety and efficacy
The document discusses a survey conducted to evaluate public perception of generic drugs in India regarding safety, efficacy, and quality. The key findings were:
- Most respondents had good knowledge about generics but negative perceptions of their quality and safety compared to branded drugs.
- Only 41% reported using generics, mainly for minor ailments. Few used them for serious conditions.
- Doctors prescribed generics for only 33% of patients.
- The survey highlights the need for efforts to enhance public trust in generic quality through education, stringent regulation, and promoting the role of pharmacists. Addressing negative perceptions is important for improving generic drug utilization and access to healthcare.
Generic drug product development.pptx
This document discusses generic drug product development. It defines generic drugs as having the same active ingredients, dosage, strength, quality and performance as brand name drugs. The main goals of generic drugs are to decrease drug prices after patents expire. The generic drug development process involves concept development, system design, detailed design, testing, and production ramp up. It also discusses the legislative history around generic drugs in the US, including the 1984 Hatch-Waxman Act, which established the Abbreviated New Drug Application pathway to expedite generic drug approval.
Lecture # 03 New Drug Approval and Development Process.
The document introduces four students who are members of the team "Pakistan Pharma Career Door". It provides brief descriptions of each student, noting their educational achievements and strengths. Sameeta Malik is an energetic student engaged in scientific activities at Dow College of Pharmacy. Iffrah Naushad is a meritorious student with experience attending national events. Abira Khalid is an associate of Dow College of Pharmacy who is talented and one of the genius students. Qaisara Boota is one of the most active students who is highly courageous and ready to take on difficult tasks. The document was prepared by these four students from Dow College of Pharmacy.
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The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
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ANDA -Abbreviated NewDrug Application.pptx
An Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug that is comparable to an existing brand-name drug in dosage form, strength, quality and intended use. An ANDA contains data demonstrating the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug may be marketed as a lower-cost alternative. The goal of the ANDA process is to expedite availability of affordable generic drugs while ensuring they are safe, effective and bioequivalent to the brand-name version.
Unit-I.pptx
This document discusses drug design and development. It begins by defining drug design as the process of finding new medications based on knowledge of a biological target. The drug is usually a small organic molecule that activates or inhibits a protein to produce therapeutic effects. It then discusses the different stages of drug development, including preclinical studies in vitro and in vivo, as well as clinical trials in four phases. Finally, it covers the concept and approval process for generic drugs, which must demonstrate bioequivalence to the brand name drug in order to receive FDA approval and be effectively substituted for the original.
Quality and formulation of medicines
This document discusses quality and formulation of medicines. It covers several topics:
1) Quality use of medicines includes selecting management options wisely based on the individual, condition, risks/benefits, and costs. It also involves using medicines safely and effectively.
2) Manufacturing of pharmaceutical products must follow good manufacturing practices to ensure quality, including production and quality control procedures.
3) Non-clinical safety studies are conducted on active substances and formulations to explore safety and inform clinical trials. Safety testing assesses margins of safety.
Fundamental of-product-development
This document discusses key aspects of product development for pharmaceutical products. It covers stages of product development including drug discovery, formulation development, process research and development, analytical research, toxicology testing, and clinical trials. It discusses important considerations for product design such as target product profiles, design specifications, commercial factors, technical risks, safety, intellectual property, and environmental impacts. Methods for testing drug-excipient compatibility like DSC, chromatography, and microscopy are also summarized. The importance of pilot plant scale up is discussed to help identify issues prior to full production.
Evaluation of public perception towards safety and efficacy
The document discusses a survey conducted to evaluate public perception of generic drugs in India regarding safety, efficacy, and quality. The key findings were:
- Most respondents had good knowledge about generics but negative perceptions of their quality and safety compared to branded drugs.
- Only 41% reported using generics, mainly for minor ailments. Few used them for serious conditions.
- Doctors prescribed generics for only 33% of patients.
- The survey highlights the need for efforts to enhance public trust in generic quality through education, stringent regulation, and promoting the role of pharmacists. Addressing negative perceptions is important for improving generic drug utilization and access to healthcare.
Generic drug product development.pptx
This document discusses generic drug product development. It defines generic drugs as having the same active ingredients, dosage, strength, quality and performance as brand name drugs. The main goals of generic drugs are to decrease drug prices after patents expire. The generic drug development process involves concept development, system design, detailed design, testing, and production ramp up. It also discusses the legislative history around generic drugs in the US, including the 1984 Hatch-Waxman Act, which established the Abbreviated New Drug Application pathway to expedite generic drug approval.
Lecture # 03 New Drug Approval and Development Process.
The document introduces four students who are members of the team "Pakistan Pharma Career Door". It provides brief descriptions of each student, noting their educational achievements and strengths. Sameeta Malik is an energetic student engaged in scientific activities at Dow College of Pharmacy. Iffrah Naushad is a meritorious student with experience attending national events. Abira Khalid is an associate of Dow College of Pharmacy who is talented and one of the genius students. Qaisara Boota is one of the most active students who is highly courageous and ready to take on difficult tasks. The document was prepared by these four students from Dow College of Pharmacy.
Application for New Drug Discovery (NDD) according to USFDA guidelines
The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
Cdsco
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
indndaandasnda-210220130515 (1).pptx inda entire
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Abbreviated New Drug Application (ANDA)
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. An ANDA provides for FDA review and approval of a generic drug product. If approved, the generic drug can be manufactured and marketed as a lower-cost alternative. All approved drugs, both innovator and generic, are listed in the Orange Book. A generic drug is comparable to the patented drug in dosage, strength, quality and intended use but does not require clinical trials to establish safety and effectiveness. The goal of an ANDA is to reduce drug prices and development time while increasing bioavailability compared to the reference listed drug. An ANDA must demonstrate equivalence to the branded drug in terms of active ingredients, use, administration, labeling,
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The document discusses the Abbreviated New Drug Application (ANDA) process overseen by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). It describes the requirements for an ANDA, including establishing bioequivalence to the reference listed drug through bioequivalence studies, and certifying patent status. Upon receiving an ANDA, the CDER determines if the application is complete and acceptable for review. If approved, generic drugs must demonstrate equivalence to the reference drug in dosage form, strength, quality and performance.
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Generic drugs provide the same clinical benefits as their brand-name counterparts at a lower cost. The document discusses the definition of generic drugs and the regulatory process for approval, including how generics are proven to be bioequivalent to the original drug but do not need to repeat clinical trials. It also addresses India's policies promoting generic drugs, the TRIPS agreement and its implications for international drug access, and initiatives like the Doha Declaration aimed at balancing intellectual property protections with public health needs.
Role of clinical trials in drug discovery &
Clinical trials play an important role in drug discovery and development. They involve several phases to test drug safety and effectiveness in humans starting with healthy volunteers and progressing to larger studies. Positive results from clinical trials provide evidence for regulatory approval and allow drugs to help patients if their benefits outweigh the risks. The goal is to develop new treatments and demonstrate they are safe and effective for their intended uses.
FDA applications in a nutshell
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
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The document then discusses the importance of quality control in the pharmaceutical industry and defines quality assurance. It states that a high quality pharmaceutical product is one that is both safe and effective, of consistent composition, and free of contaminants. It impacts both the producer and consumer. The quality control department ensures patient health is not compromised and protects the company's reputation.
Final navigating multiple clinical trial requirements for the us
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
ANDA.pptx
Generic drugs can be approved through an Abbreviated New Drug Application (ANDA) which relies on the safety and efficacy data of the branded drug. The ANDA process requires generic manufacturers to show bioequivalence to the branded drug through bioavailability and bioequivalence studies rather than completing full clinical trials. If bioequivalence is established, it demonstrates that the generic drug delivers the same amount of active ingredients into a patient's bloodstream in the same amount of time as the branded drug. The Hatch-Waxman Act established the modern ANDA approval process and aims to balance promoting generic drugs to reduce costs while also compensating branded manufacturers for regulatory time lost from patents.
Regulatory agencies
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
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20180808 generic drug approval yuan愿 song宋
The generic drug approval process requires manufacturers to demonstrate that:
1) The generic drug is pharmaceutically equivalent to the brand name drug in ingredients, dosage form, strength, and labeling.
2) The manufacturer is capable of consistently producing batches of the drug that meet quality standards.
3) Bioequivalence studies must show that the generic results in the same amount of active ingredients in the bloodstream over time as the brand name.
Once approved, generic drugs provide lower-cost alternatives to brand name drugs while meeting the same quality standards established by the FDA approval process.
Principles of Drug Discovery and Development
This document provides an overview of the drug development and approval process, including:
1) Drug discovery typically involves new disease insights, testing molecular compounds, existing treatments with unexpected effects, or new technologies. Thousands of candidates are narrowed down based on early testing.
2) Once a compound looks promising, development involves experiments to understand absorption, benefits, dosage, delivery method, side effects, and effectiveness compared to other drugs.
3) The FDA approval process includes multiple phases of clinical trials involving healthy volunteers and patients to evaluate safety, efficacy, and side effect management strategies before approval or accelerated approval in some cases.
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Formulation development is the process of combining an active drug with other ingredients to create a stable, bioavailable, and effective final product. It involves pre-formulation studies, design and testing, manufacturing, and stability testing. The goal is to identify the most effective delivery method for the active drug. Key steps include analytical development, particle characterization, dissolution testing, and excipient screening. Drugs then progress through preclinical and clinical research phases to test safety and efficacy before seeking regulatory approval. Post-approval monitoring ensures the drug's safe use. Factors like a drug's properties, intended use, and stability studies guide its formulation.
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The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
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The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. An ANDA provides for FDA review and approval of a generic drug product. If approved, the generic drug can be manufactured and marketed as a lower-cost alternative. All approved drugs, both innovator and generic, are listed in the Orange Book. A generic drug is comparable to the patented drug in dosage, strength, quality and intended use but does not require clinical trials to establish safety and effectiveness. The goal of an ANDA is to reduce drug prices and development time while increasing bioavailability compared to the reference listed drug. An ANDA must demonstrate equivalence to the branded drug in terms of active ingredients, use, administration, labeling,
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Role of clinical trials in drug discovery &
Clinical trials play an important role in drug discovery and development. They involve several phases to test drug safety and effectiveness in humans starting with healthy volunteers and progressing to larger studies. Positive results from clinical trials provide evidence for regulatory approval and allow drugs to help patients if their benefits outweigh the risks. The goal is to develop new treatments and demonstrate they are safe and effective for their intended uses.
FDA applications in a nutshell
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
IND, NDA, ANDA, SNDA
The document discusses Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental New Drug Applications (SNDAs). It provides details on the purpose and requirements of each application type, including necessary contents, guidelines, and the laws and regulations that govern the FDA drug approval process.
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Group No. 7 presented their topics for quality control. Yash Kokate chose Quality Circle, Aditya Kshirsagar chose Quality Management, and others chose related topics such as Quality Assurance and Quality Control, Objectives of Quality Control, Components of Quality Control, and Steps in Quality Control.
The document then discusses the importance of quality control in the pharmaceutical industry and defines quality assurance. It states that a high quality pharmaceutical product is one that is both safe and effective, of consistent composition, and free of contaminants. It impacts both the producer and consumer. The quality control department ensures patient health is not compromised and protects the company's reputation.
Final navigating multiple clinical trial requirements for the us
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
ANDA.pptx
Generic drugs can be approved through an Abbreviated New Drug Application (ANDA) which relies on the safety and efficacy data of the branded drug. The ANDA process requires generic manufacturers to show bioequivalence to the branded drug through bioavailability and bioequivalence studies rather than completing full clinical trials. If bioequivalence is established, it demonstrates that the generic drug delivers the same amount of active ingredients into a patient's bloodstream in the same amount of time as the branded drug. The Hatch-Waxman Act established the modern ANDA approval process and aims to balance promoting generic drugs to reduce costs while also compensating branded manufacturers for regulatory time lost from patents.
Regulatory agencies
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
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It is overview of preclinical and clinical development consideration for herbals and biologics in USA.
In this details discussion of preclinical and clinical consideration in USA. This is belong to Subject Regulatory Aspects of Herbals and Biologics
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The document describes the internship experience of working on the development of three generic pharmaceutical products (Products A, B, and C) at Xylopia, including carrying out tasks across multiple departments such as formulation development, analytical testing, process development, and regulatory compliance. Key activities involved project management, material sourcing and evaluation, manufacturing process development including granulation, milling, blending and compression, and analytical method development and validation.
20180808 generic drug approval yuan愿 song宋
The generic drug approval process requires manufacturers to demonstrate that:
1) The generic drug is pharmaceutically equivalent to the brand name drug in ingredients, dosage form, strength, and labeling.
2) The manufacturer is capable of consistently producing batches of the drug that meet quality standards.
3) Bioequivalence studies must show that the generic results in the same amount of active ingredients in the bloodstream over time as the brand name.
Once approved, generic drugs provide lower-cost alternatives to brand name drugs while meeting the same quality standards established by the FDA approval process.
Principles of Drug Discovery and Development
This document provides an overview of the drug development and approval process, including:
1) Drug discovery typically involves new disease insights, testing molecular compounds, existing treatments with unexpected effects, or new technologies. Thousands of candidates are narrowed down based on early testing.
2) Once a compound looks promising, development involves experiments to understand absorption, benefits, dosage, delivery method, side effects, and effectiveness compared to other drugs.
3) The FDA approval process includes multiple phases of clinical trials involving healthy volunteers and patients to evaluate safety, efficacy, and side effect management strategies before approval or accelerated approval in some cases.
school practice_240130_141325.PDF
Formulation development is the process of combining an active drug with other ingredients to create a stable, bioavailable, and effective final product. It involves pre-formulation studies, design and testing, manufacturing, and stability testing. The goal is to identify the most effective delivery method for the active drug. Key steps include analytical development, particle characterization, dissolution testing, and excipient screening. Drugs then progress through preclinical and clinical research phases to test safety and efficacy before seeking regulatory approval. Post-approval monitoring ensures the drug's safe use. Factors like a drug's properties, intended use, and stability studies guide its formulation.
Veena Sanjay Katoriya
The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
Regulatory affairs in Pharmaceutical Industry
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
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Final navigating multiple clinical trial requirements for the us
Final navigating multiple clinical trial requirements for the us
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Preclinical and Clinical Development Consideration in Herbals & Biologics in USA
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From Blame to Gain: Achieving Sales and Marketing Alignment to Drive B2B Growth.
Tired of the perpetual tug-of-war between your sales and marketing teams? Come hear Demandbase Chief Marketing Officer, Kelly Hopping and Chief Sales Officer, John Eitel discuss key insights from their new book, “Yes, It’s Your Fault! From Blame to Gain: Achieving Sales and Marketing Alignment to Drive B2B Growth.”
They’ll share their no-nonsense approach to bridging the sales and marketing divide to drive true collaboration — once and for all.
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The underlying dynamics fueling sales and marketing misalignment
How to implement practical solutions without disrupting day-to-day operations
How to cultivate a culture of collaboration and unity for long-term success
How to align on metrics that matter
Why it’s essential to break down technology and data silos
How ABM can be a powerful unifier
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The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.Unleash the Power of Storytelling - Win Hearts, Change Minds, Get Results - R...
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Mastering Local SEO for Service Businesses in the AI Era"" is tailored specifically for local service providers like plumbers, dentists, and others seeking to dominate their local search landscape. This session delves into leveraging AI advancements to enhance your online visibility and search rankings through the Content Factory model, designed for creating high-impact, SEO-driven content. Discover the Dollar-a-Day advertising strategy, a cost-effective approach to boost your local SEO efforts and attract more customers with minimal investment. Gain practical insights on optimizing your online presence to meet the specific needs of local service seekers, ensuring your business not only appears but stands out in local searches. This concise, action-oriented workshop is your roadmap to navigating the complexities of digital marketing in the AI age, driving more leads, conversions, and ultimately, success for your local service business.
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Build marketing products across the customer journey to grow your business and build a relationship with your customer. For example you can build graders, calculators, quizzes, recommendations, chatbots or AR apps. Things like Hubspot's free marketing grader, Moz's site analyzer, VenturePact's mobile app cost calculator, new york times's dialect quiz, Ikea's AR app, L'Oreal's AR app and Nike's fitness apps. All of these examples are free tools that help drive engagement with your brand, build an audience and generate leads for your core business by adding value to a customer during a micro-moment.
Key Takeaways:
Learn how to use specific GPTs to help you Learn how to build your own marketing tools
Generate marketing ideas for your business How to think through and use AI in marketing
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In this humorous and data-heavy Master Class, join us in a joyous celebration of life honoring the long list of SEO tactics and concepts we lost this year. Remember fondly the beautiful time you shared with defunct ideas like link building, keyword cannibalization, search volume as a value indicator, and even our most cherished of friends: the funnel. Make peace with their loss as you embrace a new paradigm for organic content: Pillar-Based Marketing. Along the way, discover that the results that old SEO and all its trappings brought you weren’t really very good at all, actually.
In this respectful and life-affirming service—erm, session—join Ryan Brock (Chief Solution Officer at DemandJump and author of Pillar-Based Marketing: A Data-Driven Methodology for SEO and Content that Actually Works) and leave with:
• Clear and compelling evidence that most legacy SEO metrics and tactics have slim to no impact on SEO outcomes
• A major mindset shift that eliminates most of the metrics and tactics associated with SEO in favor of a single metric that defines and drives organic ranking success
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Mastering SEO for Google in the AI Era - Dennis YuDigiMarCon - Digital Marketing, Media and Advertising Conferences & Exhibitions
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Primary Learning Objective
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2: Gain an accurate analysis of the continuously developing customer journey and business intelligence. Primary Learning Objective
3: Grow revenue at lower costs with more efficient marketing and business operations.How to Make Your Trade Show Booth Stand Out
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Incorporate interactive elements that engage visitors
Use effective branding and visuals to reinforce your message
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Create memorable experiences that leave a lasting impression
Transform your trade show presence with these proven tactics and ensure your booth stands out from the competition. Download the PDF now and start planning your next successful exhibit!
Data-Driven Personalization - Build a Competitive Advantage by Knowing Your C...
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Presentation00000001.pptx
- 2. GENERIC DRUG PRODUCT DEVELOPMENT • ROLL NO-0381 •ROLL NO- 0382 •ROLLNO -0383 • ROLLNO- 0384 GAURAV KUMAR DIYA RAJ DHRUV PRAKASH BHAI VEKARIA DIPANSHU MEVAL
- 3. CONTENT Introduction to Generic Drug Product Development Research and Development Clinical Trials Regulatory Approval Conclusion
- 4. Introduction to Generic Drug Product Development • Generic drug product development is a process of creating medications that are identical to the original, brand-name product. This process involves research and development, clinical trials, and regulatory approval. By creating generic drugs, pharmaceutical companies are able to provide affordable medications to patients. • Generic drugs are typically less expensive than brand-name drugs, as they do not have to go through the same lengthy and expensive process of research and development. Generic drugs also have the same active ingredients, dosage forms, safety, strength, quality, and intended use as the brand-name drug. This allows generic drugs to be used interchangeably with the brand-name drug.
- 5. Research and Development • The research and development process for generic drug product development involves the identification of active ingredients, the selection of appropriate dosage forms, and the development of a manufacturing process. The active ingredients must be identified and tested to ensure they are safe and effective. The dosage forms must be selected to ensure that the drug is delivered to the body in an effective manner. • The manufacturing process must be developed to ensure that the drug is produced in a safe and consistent manner. This process includes the selection of raw materials, the development of manufacturing processes, and the validation of the processes to ensure that the drug is produced according to the required quality standards.
- 6. Clinical Trials & Regulatory Approval • Clinical trials are conducted to ensure that the generic drug product is safe and effective. The trials involve the administration of the drug to human subjects to evaluate its safety and effectiveness. The trials are conducted in accordance with Good Clinical Practices, which are guidelines established by the FDA to ensure that the trials are conducted in a safe and ethical manner. • The results of the clinical trials are evaluated to determine if the drug is safe and effective. The data from the trials is then submitted to the FDA for review and approval. Once the drug is approved, it can be marketed and sold. • The FDA reviews the data from the clinical trials to determine if the drug is safe and effective. The FDA also reviews the manufacturing process to ensure that the drug is produced in a safe and consistent manner. Once the drug is approved, it can be marketed and sold. • Generic drugs must meet the same standards of safety and effectiveness as the brand-name drug. Generic drugs must also be manufactured in accordance with the same standards as the brand-name drug. This ensures that the generic drug is safe and effective for use by patients.
- 7. Conclusion • Generic drug product development is a process of creating medications that are identical to the original, brand-name product. This process involves research and development, clinical trials, and regulatory approval. By creating generic drugs, pharmaceutical companies are able to provide affordable medications to patients. • Generic drugs are typically less expensive than brand-name drugs, as they do not have to go through the same lengthy and expensive process of research and development. Generic drugs also have the same active ingredients, dosage forms, safety, strength, quality, and intended use as the brand- name drug. This allows generic drugs to be used interchangeably with the brand-name drug.