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Generics drug approval and timelines in china
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Recommended
Basic Candlestick Pattern in stock market, finance
The document provides information on various candlestick patterns used in technical analysis of financial markets. It begins with definitions of basic candlestick types like doji and hanging man candles. It then outlines several reversal patterns like morning star and engulfing patterns that indicate a change in trend. Continuation patterns like rising three methods and falling three methods that suggest the current trend will persist are also discussed. The document provides illustrations and explanations of many common candlestick patterns to help readers understand how to interpret these visual representations of market price action.
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This document discusses critical material attributes (CMA), critical process parameters (CPP), and critical quality attributes (CQA) for various pharmaceutical unit operations used in manufacturing oral solid dosage forms. It provides examples of CMAs, CPPS, and CQAs for common processes like blending, granulation, drying, compaction, and tableting. The goal is to identify material traits and processing conditions that most impact the critical quality standards of the finished drugs.
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Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
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Pharma figures 2017 ; Efpia
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CTD ~ Common Technical Document
The document describes the five modules of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format for ASEAN countries. Module 1 contains regional administrative information. Module 2 provides an overall summary of Modules 3, 4, and 5, including quality, non-clinical, and clinical overviews. Module 3 includes chemistry, manufacturing, and quality control documents. Module 4 contains non-clinical safety data. Module 5 provides clinical study reports, though generics only need to include bioequivalence studies. The CTD format is required for both new drug and generic applications in ASEAN countries.
Points to be considered in topical formulation design
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Topicals product development NDA,ANDA
The document discusses requirements for new drug applications and abbreviated new drug applications for topical products. A full NDA requires extensive safety studies including toxicity, skin irritation, and sensitization testing as well as two clinical efficacy studies and manufacturing controls. An ANDA for generic topical products requires abbreviated safety testing for skin irritation and toxicity along with manufacturing controls and either in vivo bioequivalence studies or in vitro release testing, and qualitatively and quantitatively matching inactive ingredients.
Comparasion of IND,NDA,BLA,ANDA,OTC
IND refers to investigational new drugs used in clinical trials. NDA and BLA are for approval of new drugs and biologics respectively, requiring clinical data. ANDA is an abbreviated application for generic drugs, needing bioequivalence data. OTC drugs are approved via monographs without premarket review or the orange/purple book.
Pharmaceutical QbD concepts for drug development
The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
Generic product development with QbD pathway
This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.
Qbd scheme
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Comparative regulatory of neutraceuticals
This document compares the regulatory registration of nutraceuticals in India, Canada, and Australia. It outlines key differences in how each country defines nutraceuticals, the regulatory authorities responsible for registration, and requirements for registration like product evaluation, licensing, and health claims approval. The table shows that regulations were established in 2011 in India, 2004 in Canada, and 1989 in Australia, with each country taking different approaches to nutraceutical definitions and registration processes.
Paragraph 1,2,3,4 certification usfda
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Generics lead the way
This document discusses the global generic pharmaceutical market and product development. It begins with an introduction that outlines increasing demand for medicines globally and a shift toward generics. It then provides details on the size and growth of the global generics market. The document discusses key aspects of pharmaceutical research and development as well as quality by design (QbD) approaches. It outlines the common regulatory requirements for different markets like the US, Europe, and India. Finally, it concludes that regulations favoring generics and health insurance coverage will boost the generics market, while consolidation and complex therapies will present challenges.
Intellectual patent rights(ipr) patents, copyrights, trademarks
The document discusses different types of intellectual property rights (IPR), including patents, copyrights, trademarks, and geographical indicators. Patents can be granted for inventions that are novel, non-obvious, and capable of industrial application. Copyright automatically protects original creative works from copying. Trademarks distinguish goods and services through distinctive words, numbers, designs, shapes or colors. A patent attorney can help guide an inventor through the patent application and approval process.
Tablet press operation
Tablet pressing is the final step in manufacturing tablets. It involves compressing powdered materials into a solid dosage form using compression forces. The powder is fed into the tablet press machine where molds or punches compress it into the desired shape and size before ejecting the finished tablets for further processing or packaging.
QbD
The document outlines the key steps in a Quality by Design (QbD) approach including identifying critical quality attributes and critical process parameters, developing a design space that mathematically expresses their relationship, designing and implementing a control strategy, continually improving the product lifecycle through risk assessment and management, and developing a robust process to monitor critical quality attributes and adjust critical process parameters accordingly.
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Pharma figures 2017 ; Efpia
The pharmaceutical industry is a key driver of scientific and medical progress. It invests billions annually in research and development to develop new medicines. In Europe, the industry invested an estimated €33.6 billion in R&D in 2015 and directly employs over 745,000 people. However, the industry faces challenges from fiscal austerity in Europe and increasing competition from emerging markets with fast-growing pharmaceutical sectors like Brazil and China.
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CTD ~ Common Technical Document
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Points to be considered in topical formulation design
This document outlines key points to consider in topical formulation design, including the drug substance, excipients, physicochemical properties, container closure system, chemical and physical stability, manufacturability and scalability, preservative efficacy, and patient acceptance. Some important considerations are the quality and physical characteristics of the active pharmaceutical ingredient and excipients, ensuring compatibility between ingredients, and establishing a target product profile that maintains consistency of the formulation over time. Process parameters and equipment must also be identified during development to enable scalability and reproducibility of the commercial manufacturing process.
Topicals product development NDA,ANDA
The document discusses requirements for new drug applications and abbreviated new drug applications for topical products. A full NDA requires extensive safety studies including toxicity, skin irritation, and sensitization testing as well as two clinical efficacy studies and manufacturing controls. An ANDA for generic topical products requires abbreviated safety testing for skin irritation and toxicity along with manufacturing controls and either in vivo bioequivalence studies or in vitro release testing, and qualitatively and quantitatively matching inactive ingredients.
Comparasion of IND,NDA,BLA,ANDA,OTC
IND refers to investigational new drugs used in clinical trials. NDA and BLA are for approval of new drugs and biologics respectively, requiring clinical data. ANDA is an abbreviated application for generic drugs, needing bioequivalence data. OTC drugs are approved via monographs without premarket review or the orange/purple book.
Pharmaceutical QbD concepts for drug development
The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
Generic product development with QbD pathway
This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.
Qbd scheme
This document outlines a Quality by Design (QbD) scheme for developing a pharmaceutical product. The scheme involves defining the quality target product profile and critical quality attributes, conducting an initial risk assessment of the drug substance and formulation variables, processes, and packaging. It then proposes risk mitigation strategies, an updated risk assessment, establishing a design space, quality risk management plans, and control strategies.
Comparative regulatory of neutraceuticals
This document compares the regulatory registration of nutraceuticals in India, Canada, and Australia. It outlines key differences in how each country defines nutraceuticals, the regulatory authorities responsible for registration, and requirements for registration like product evaluation, licensing, and health claims approval. The table shows that regulations were established in 2011 in India, 2004 in Canada, and 1989 in Australia, with each country taking different approaches to nutraceutical definitions and registration processes.
Paragraph 1,2,3,4 certification usfda
1) When filing an ANDA application, an applicant must provide information on any patents listed for the reference drug in the Orange Book.
2) In its application, a generic applicant must submit one of four certifications regarding the patents: that there are no patents (Paragraph I); any patents have expired (Paragraph II); any patents will expire on a specific date (Paragraph III); or the generic product does not infringe on or the patents are invalid (Paragraph IV).
3) A Paragraph I or II certification allows immediate approval, while a Paragraph III approval is effective after patent expiration. A Paragraph IV certification requires notifying the innovator and may allow early generic entry.
Generics lead the way
This document discusses the global generic pharmaceutical market and product development. It begins with an introduction that outlines increasing demand for medicines globally and a shift toward generics. It then provides details on the size and growth of the global generics market. The document discusses key aspects of pharmaceutical research and development as well as quality by design (QbD) approaches. It outlines the common regulatory requirements for different markets like the US, Europe, and India. Finally, it concludes that regulations favoring generics and health insurance coverage will boost the generics market, while consolidation and complex therapies will present challenges.
Intellectual patent rights(ipr) patents, copyrights, trademarks
The document discusses different types of intellectual property rights (IPR), including patents, copyrights, trademarks, and geographical indicators. Patents can be granted for inventions that are novel, non-obvious, and capable of industrial application. Copyright automatically protects original creative works from copying. Trademarks distinguish goods and services through distinctive words, numbers, designs, shapes or colors. A patent attorney can help guide an inventor through the patent application and approval process.
Tablet press operation
Tablet pressing is the final step in manufacturing tablets. It involves compressing powdered materials into a solid dosage form using compression forces. The powder is fed into the tablet press machine where molds or punches compress it into the desired shape and size before ejecting the finished tablets for further processing or packaging.
QbD
The document outlines the key steps in a Quality by Design (QbD) approach including identifying critical quality attributes and critical process parameters, developing a design space that mathematically expresses their relationship, designing and implementing a control strategy, continually improving the product lifecycle through risk assessment and management, and developing a robust process to monitor critical quality attributes and adjust critical process parameters accordingly.
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