This document provides guidance on bracketing and matrixing designs for stability testing of drug substances and products. Bracketing involves testing samples only at the extremes of certain design factors, like strength or container size, at all time points. Matrixing involves testing a subset of all possible samples at each time point, assuming the stability of each subset represents all samples. The document defines when bracketing and matrixing can be applied and provides examples of design factors and sample designs. It notes that reduced designs may establish a shorter shelf life than a full design due to less collected data.
This presentation is about the force distribution in tablet compression, energy involved in compression,compression mechanism and evaluation of the tablet formulations.
The document discusses the Master Formula Record (MFR), which contains all information about the manufacturing process for a pharmaceutical product. It is prepared by the research and development team and used as a reference standard for preparing batch manufacturing records. The MFR includes details like product name, ingredients, batch size, manufacturing process steps, packaging process, and expected yields. It provides standardized instructions for consistently producing batches of a product.
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
A review on waiving in vivo bioequivalence tests or Biovaiwer, with a case review on the biowaiver monograph on Ibuprofen by H. POTTHAST, J.B. DRESSMAN, H.E. JUNGINGER, K.K. MIDHA, H. OESER, V.P. SHAH,
H. VOGELPOEL, D.M. BARENDS
in J Pharm Sci 94:2121–2131, 2005
Explaining different approaches to waive different BCS class medicines based on their solubility and permeability, as is described by FDA and WHO
This document discusses drug product performance and bioequivalence studies. It defines drug product performance as the release of the drug substance from the product leading to bioavailability, which relates to clinical safety and efficacy. Bioequivalence studies compare formulations and are used to assess the impact of changes to the drug substance, formulation, or manufacturing process. They can be conducted in vivo using pharmacokinetic or pharmacodynamic endpoints or in vitro using dissolution studies.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
This presentation is about the force distribution in tablet compression, energy involved in compression,compression mechanism and evaluation of the tablet formulations.
The document discusses the Master Formula Record (MFR), which contains all information about the manufacturing process for a pharmaceutical product. It is prepared by the research and development team and used as a reference standard for preparing batch manufacturing records. The MFR includes details like product name, ingredients, batch size, manufacturing process steps, packaging process, and expected yields. It provides standardized instructions for consistently producing batches of a product.
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
This document discusses bracketing and matrixing designs for stability testing of new drug substances and products according to ICH Q1D guidelines. Bracketing design involves testing only the extremes of design factors like strength or container size, assuming stability of intermediates is represented by extremes. Matrixing design involves testing selected combinations of factors at each time point rather than all combinations at all time points. Both designs provide reduced testing compared to full design testing all samples at all time points, but require justification and carry potential risks of underestimating shelf life if variability is high.
ICH Guideline Q8 Pharmaceutical DevelopmentBINDIYA PATEL
The document discusses ICH Q8 guidelines, which aim to provide harmonized guidance for pharmaceutical development. It introduces key concepts like design space and risk-based approaches. The guidelines encourage developing products and processes based on scientific understanding of critical quality attributes and how they are impacted by material attributes and process parameters. This facilitates continuous improvement and assurance of quality without need for regulatory review when operating within the approved design space. Overall, ICH Q8 promotes moving from quality by testing to quality by design.
A review on waiving in vivo bioequivalence tests or Biovaiwer, with a case review on the biowaiver monograph on Ibuprofen by H. POTTHAST, J.B. DRESSMAN, H.E. JUNGINGER, K.K. MIDHA, H. OESER, V.P. SHAH,
H. VOGELPOEL, D.M. BARENDS
in J Pharm Sci 94:2121–2131, 2005
Explaining different approaches to waive different BCS class medicines based on their solubility and permeability, as is described by FDA and WHO
This document discusses drug product performance and bioequivalence studies. It defines drug product performance as the release of the drug substance from the product leading to bioavailability, which relates to clinical safety and efficacy. Bioequivalence studies compare formulations and are used to assess the impact of changes to the drug substance, formulation, or manufacturing process. They can be conducted in vivo using pharmacokinetic or pharmacodynamic endpoints or in vitro using dissolution studies.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
WHAT IS COMPRESSION ?
Compression means reduction of bulk volume of material as a result of the removal of gaseous phase (air) by applied pressure
WHAT IS CONSOLIDATION?
Consolidation is an increase in mechanical strength of material resulting from particle - particle interactions.
Drug stability refers to a drug substance or product remaining within established specifications over time. The stability of a product is expressed as its shelf life or expiry period. Stability testing involves multiple stages from early stress testing to ongoing long-term testing as required by regulatory bodies. Stability is affected by various factors related to the drug, formulation, and environment. Reduced stability study designs like bracketing and matrixing allow testing of representative samples and are acceptable with proper scientific justification.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
Drug-excipient compatibility studies are important to identify compatible excipients for drug formulations. Compatibility can be tested using various analytical techniques including thermal methods like DSC and DTA, accelerated stability studies, spectroscopy like FTIR, and chromatography like TLC. Incompatibilities are identified by changes in thermal behavior, degradation of the drug, or appearance of new peaks in analytical tests. Common techniques involve storing drug-excipient mixtures under accelerated conditions and monitoring the samples for physical or chemical changes over time. The results of compatibility studies provide critical information for formulation development and regulatory filings.
The tablet compression process involves different steps of the rearrangement of particles within the die cavity and initial elimination of voids. It is very necessary for the academicians, students, production chemists, managers in the pharma background, to have the idea about the physics behind the tablet compression process.
The document discusses key topics in powder compression:
1. Compression properties like compressibility and compactibility are important for forming tablets.
2. Axial and radial forces are exerted during compression and must be withstood for decompression.
3. The compression process involves stages like particle rearrangement, deformation, fragmentation, and bonding which increase density and form strong tablets.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
The document discusses orodispersible films as a drug delivery system. It provides an introduction to orodispersible films, describes their advantages over other dosage forms like tablets, and discusses various aspects of formulation such as polymers, plasticizers, and drug loading. The document also summarizes evaluation methods for orodispersible films and provides examples of marketed products in this category. In conclusion, it states that orodispersible films are considered a promising drug delivery system, especially for pediatric and geriatric patients due to their ease of administration.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
Pharmaceutical aerosols can be filled using either a cold-fill or pressure-fill process depending on the nature of the product concentrate and propellant. The cold-fill process involves cooling the concentrate and propellant below their boiling points to liquefy them before filling the chilled container. The pressure-fill process places the concentrate in the container before forcing the hydrocarbon propellant in under pressure. Both processes involve sealing the valve and checking for leaks by heating the filled container in a water bath.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
This document discusses tablet manufacturing and quality control. It begins by explaining how direct compression became the most advanced tablet manufacturing technique as it requires fewer steps and less time than older granulation methods. It then describes common excipients used in tablets and the three main manufacturing methods - direct compression, dry granulation, and wet granulation. The mechanisms and components of rotary tablet presses are outlined. Quality control tests for tablets like hardness, thickness, friability, disintegration, weight variation and dissolution are also summarized. References on pharmaceutical manufacturing and quality standards are provided.
Self Micro Emulsifying Drug Delivery SystemSagar Savale
The document provides information on self-microemulsifying drug delivery systems (SMEDDS), including their definition, components, mechanism of action, formulation, evaluation, and applications. SMEDDS consist of oils, surfactants, and cosolvents/surfactants that form fine oil-in-water microemulsions upon mild agitation followed by dilution in aqueous fluids. The small droplet size of SMEDDS enhances drug absorption by increasing surface area and promoting intestinal lymphatic transport. SMEDDS have shown improved oral absorption for several poorly soluble drugs over conventional formulations.
The document discusses various techniques to enhance the solubility and dissolution rate of poorly soluble drugs, including physical and chemical modifications. Some key points:
1. Physical modifications like particle size reduction through micronization, nanosuspensions, and sonocrystallization can increase surface area and solubility. Other methods are polymorphism, solid dispersions, and complexation.
2. Chemical modifications involve changing pH, adding buffers, or derivatizing drugs.
3. Other solubility enhancement methods discussed are co-crystallization, cosolvency, hydrotrophy, solubilizing agents, and using soluble prodrugs. Compaction analysis and different compaction profiles are also summarized.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document provides guidance on bracketing and matrixing study designs for stability testing of new drug substances and products. Bracketing involves testing only samples on the extremes of certain design factors, like strength or container size, at all time points. Matrixing involves testing a subset of all possible samples at each time point. The guideline outlines when and how bracketing and matrixing can be applied, including design examples. Any reduced design must be justified and have the ability to adequately predict shelf life or retest period. All factor combinations should be tested at initial, final, and 12-month time points.
BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES...Moremrunal
This document discusses guidelines for applying bracketing and matrixing designs to stability testing as outlined in ICH Q1A. Bracketing involves testing only the extremes of design factors like strength, while assuming stability of intermediates is represented by the extremes. Matrixing involves testing selected samples of all combinations at time points. Reduced designs can shorten testing if justified based on supporting data variability and product stability. However, reduced designs may underestimate shelf life compared to full testing and miss some degradation interactions. Data from reduced designs should still be evaluated statistically.
WHAT IS COMPRESSION ?
Compression means reduction of bulk volume of material as a result of the removal of gaseous phase (air) by applied pressure
WHAT IS CONSOLIDATION?
Consolidation is an increase in mechanical strength of material resulting from particle - particle interactions.
Drug stability refers to a drug substance or product remaining within established specifications over time. The stability of a product is expressed as its shelf life or expiry period. Stability testing involves multiple stages from early stress testing to ongoing long-term testing as required by regulatory bodies. Stability is affected by various factors related to the drug, formulation, and environment. Reduced stability study designs like bracketing and matrixing allow testing of representative samples and are acceptable with proper scientific justification.
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
Drug-excipient compatibility studies are important to identify compatible excipients for drug formulations. Compatibility can be tested using various analytical techniques including thermal methods like DSC and DTA, accelerated stability studies, spectroscopy like FTIR, and chromatography like TLC. Incompatibilities are identified by changes in thermal behavior, degradation of the drug, or appearance of new peaks in analytical tests. Common techniques involve storing drug-excipient mixtures under accelerated conditions and monitoring the samples for physical or chemical changes over time. The results of compatibility studies provide critical information for formulation development and regulatory filings.
The tablet compression process involves different steps of the rearrangement of particles within the die cavity and initial elimination of voids. It is very necessary for the academicians, students, production chemists, managers in the pharma background, to have the idea about the physics behind the tablet compression process.
The document discusses key topics in powder compression:
1. Compression properties like compressibility and compactibility are important for forming tablets.
2. Axial and radial forces are exerted during compression and must be withstood for decompression.
3. The compression process involves stages like particle rearrangement, deformation, fragmentation, and bonding which increase density and form strong tablets.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
The document discusses orodispersible films as a drug delivery system. It provides an introduction to orodispersible films, describes their advantages over other dosage forms like tablets, and discusses various aspects of formulation such as polymers, plasticizers, and drug loading. The document also summarizes evaluation methods for orodispersible films and provides examples of marketed products in this category. In conclusion, it states that orodispersible films are considered a promising drug delivery system, especially for pediatric and geriatric patients due to their ease of administration.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
This guideline is a revised of the ICHQ1A –stability data package for new drug substance /DRUG PRODUCT .The [urpose of guideline to define stability data package that sufficient for a registration application within the 3 regions of EU ,JAPAN & USA & to maintain the quality of drug products, in relation to safety , efficacy & acceptability throughout the propose shelf life.
This document summarizes the ICH guideline for stability testing. The ICH provides guidance on stability testing to ensure drug quality over time under various environmental conditions. Key aspects covered include the objectives of stability testing, variables that affect stability, terminology, and ICH guidelines Q1A through Q1F which provide detailed recommendations on stability testing procedures, data evaluation, and submissions for registration.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
Pharmaceutical aerosols can be filled using either a cold-fill or pressure-fill process depending on the nature of the product concentrate and propellant. The cold-fill process involves cooling the concentrate and propellant below their boiling points to liquefy them before filling the chilled container. The pressure-fill process places the concentrate in the container before forcing the hydrocarbon propellant in under pressure. Both processes involve sealing the valve and checking for leaks by heating the filled container in a water bath.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
This document discusses tablet manufacturing and quality control. It begins by explaining how direct compression became the most advanced tablet manufacturing technique as it requires fewer steps and less time than older granulation methods. It then describes common excipients used in tablets and the three main manufacturing methods - direct compression, dry granulation, and wet granulation. The mechanisms and components of rotary tablet presses are outlined. Quality control tests for tablets like hardness, thickness, friability, disintegration, weight variation and dissolution are also summarized. References on pharmaceutical manufacturing and quality standards are provided.
Self Micro Emulsifying Drug Delivery SystemSagar Savale
The document provides information on self-microemulsifying drug delivery systems (SMEDDS), including their definition, components, mechanism of action, formulation, evaluation, and applications. SMEDDS consist of oils, surfactants, and cosolvents/surfactants that form fine oil-in-water microemulsions upon mild agitation followed by dilution in aqueous fluids. The small droplet size of SMEDDS enhances drug absorption by increasing surface area and promoting intestinal lymphatic transport. SMEDDS have shown improved oral absorption for several poorly soluble drugs over conventional formulations.
The document discusses various techniques to enhance the solubility and dissolution rate of poorly soluble drugs, including physical and chemical modifications. Some key points:
1. Physical modifications like particle size reduction through micronization, nanosuspensions, and sonocrystallization can increase surface area and solubility. Other methods are polymorphism, solid dispersions, and complexation.
2. Chemical modifications involve changing pH, adding buffers, or derivatizing drugs.
3. Other solubility enhancement methods discussed are co-crystallization, cosolvency, hydrotrophy, solubilizing agents, and using soluble prodrugs. Compaction analysis and different compaction profiles are also summarized.
This document defines stability testing requirements for new drug products. It outlines that three primary batches packaged in the proposed marketing container closure system should undergo long term testing at 25°C/60% RH or 30°C/65% RH, accelerated testing at 40°C/75% RH, and intermediate testing if needed. Specifications, frequency of testing, storage conditions and a post-approval stability commitment are also addressed. The purpose is to provide evidence of a drug product's quality over time under various environmental conditions and establish a shelf life.
This document provides guidance on bracketing and matrixing study designs for stability testing of new drug substances and products. Bracketing involves testing only samples on the extremes of certain design factors, like strength or container size, at all time points. Matrixing involves testing a subset of all possible samples at each time point. The guideline outlines when and how bracketing and matrixing can be applied, including design examples. Any reduced design must be justified and have the ability to adequately predict shelf life or retest period. All factor combinations should be tested at initial, final, and 12-month time points.
BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES...Moremrunal
This document discusses guidelines for applying bracketing and matrixing designs to stability testing as outlined in ICH Q1A. Bracketing involves testing only the extremes of design factors like strength, while assuming stability of intermediates is represented by the extremes. Matrixing involves testing selected samples of all combinations at time points. Reduced designs can shorten testing if justified based on supporting data variability and product stability. However, reduced designs may underestimate shelf life compared to full testing and miss some degradation interactions. Data from reduced designs should still be evaluated statistically.
Bracketing and matrixing designs (Q1D) AISSMS College Of PharmacyAISSMS
Read an interesting information about Bracketing and Matrixing designs for stability testing of new drug substances and products by AISSMS College Of Pharmacy.
The document discusses stability testing of pharmaceutical products. It defines the purpose of stability testing as providing evidence of how a product's quality varies over time under the influence of factors like temperature, humidity and light. There are two main types of stability studies: stability studies and accelerated stability studies. Stability studies involve testing products under various storage conditions like long term, intermediate and accelerated conditions over minimum time periods to establish a product's shelf life.
Ich guidelines for stability testing of biotechnological biological products (1)Dr Raj kumar Kudari
This document provides guidelines for stability testing of biotechnological and biological products. It discusses selecting representative batches of drug substance and drug product for testing, establishing a stability-indicating profile including potency, purity, and other characteristics, and testing under various storage conditions like temperature, humidity, and accelerated/stress conditions. The guidelines aim to ensure biologics maintain biological activity and avoid degradation during their intended storage period.
Adaptive clinical trials have risen in popularity and gained more attention since the FDA Critical Path Initiative (2004) and Critical Path Opportunity List (2006) called for innovative solutions to transform the way medicinal products are developed, evaluated, and manufactured. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
The document discusses International Council for Harmonisation (ICH) guidelines related to stability testing of drug substances and products. It provides an overview of the historical background and development of ICH. It summarizes several ICH guidelines including Q1A on stability testing, Q1B on photostability testing, Q1C on stability testing for new dosage forms, and Q1D on bracketing and matrixing designs for stability testing. It also discusses stability storage conditions, principles of ICH guidelines for stability testing, and the objectives of guidelines like Q1E on evaluation of stability data.
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
This document summarizes WHO guidelines for stability testing of liquid dosage forms. It outlines the key aspects that should be covered in stability protocols, including specifications tested, storage conditions and minimum time periods for long term, intermediate and accelerated studies. Specific recommendations are provided for drug substances, oral solutions, suspensions, small volume parenterals and other dosage forms. The purpose of stability testing is to provide evidence of a product's quality over time under various environmental factors and establish a re-test period or shelf life. Ongoing stability studies are also required to monitor products throughout their shelf life.
This document discusses stability studies and testing. Stability studies are conducted to provide evidence on how the quality of a drug substance or product varies over time under the influence of environmental factors like temperature, humidity, and light. They are required to recommend storage conditions, establish retest and shelf life periods, review product quality, and meet regulatory requirements. Key aspects covered include guidelines for stability testing, types of studies (long term, intermediate, accelerated), storage conditions, specifications, testing frequency, and requirements for stability protocols, batches, and reports.
The document provides guidance on stability testing and data requirements for biotechnological/biological products. It recommends that stability data be provided for at least 3 batches of the drug substance manufactured at pilot scale and stored under intended conditions for 6 months or longer. For drug products, data is required from 3 batches derived from different drug substance batches, with a minimum of 6 months data if a shelf life greater than 6 months is claimed. Products should be tested regularly as per predefined protocols, with more frequent testing in early time periods. Specifications should include stability-indicating parameters to monitor purity, identity, potency and other characteristics over the proposed shelf life.
This document provides guidelines for stability studies of drug products, including:
- Recommendations for the design of stability studies, including parameters to test, specifications, storage conditions and frequency of testing.
- Examples of protocols, reports and statistical approaches.
- Guidance on selection of batches, reduced designs, and extrapolation of data for shelf-life estimation.
- Annexes covering specific topics like types of packaging materials and decision trees for data evaluation.
The guidelines aim to provide a standardized approach to stability testing while allowing flexibility for different products and scientific considerations.
This document provides guidelines for stability studies of drug products, including objectives, scope, design considerations, testing parameters, storage conditions, evaluation, and reporting requirements. Key aspects covered include testing at least three primary batches of new chemical entities and two batches of generics, analyzing physical, chemical, and microbiological attributes, storing products under various conditions like room temperature and refrigeration, evaluating data at multiple time points, and committing to a shelf life. The guidelines aim to ensure drug products maintain quality, safety and efficacy throughout their proposed shelf life.
Stability testing is conducted to provide evidence on how the quality of a drug substance or product varies over time under various environmental conditions. It establishes a re-test period or shelf life and recommended storage conditions. Key aspects of stability testing include stress testing of the drug substance, selection of representative batches in final packaging, specification testing at various time points under different storage conditions, evaluation of results, and commitments for ongoing testing. Bracketing and matrixing designs can reduce testing requirements if the stability is expected to be similar across product variations.
Shivam Dubey Pharmaceutics Assignment 03: ICH Guidelines On Drug StudiesMrHotmaster1
The document summarizes ICH guidelines for stability studies of new drug substances and products. It discusses the purpose of stability testing to ensure drug quality over shelf life. Key guidelines covered include Q1A for stability testing of new drug substances and products, Q1B for photostability testing, Q1C for new dosage forms, and Q1D for bracketing and matrixing designs. The summary also discusses long term, intermediate, and accelerated storage conditions for drug substances and products, and criteria for evaluation of stability data and establishing retest periods or shelf lives.
This document discusses stability studies of a finished pharmaceutical product (FPP) by Zafar Mahmood. It defines the purpose of stability testing as providing evidence of how quality varies over time under various environmental factors like temperature and humidity. This helps establish a product's shelf life and recommended storage conditions. The document outlines types of stability studies including real-time, intermediate, and accelerated studies conducted under different climatic zones and temperatures. It provides guidance on selecting batches, container closure systems, specifications, testing frequency, storage conditions, evaluation, and ongoing stability programs to ensure product quality over time.
Thuốc thử là hóa chất không thể thiếu của bất kỳ phòng thí nghiệm nào và do đó đóng vai trò quan trọng trong việc đảm bảo kết quả phân tích. Thuốc thử phải phù hợp với mục đích sử dụng.
Trong phòng thí nghiệm, hai loại thuốc thử chính thường được phân biệt: loại thương mại và loại được điều chế trong phòng thí nghiệm. Hai loại thuốc thử này chủ yếu được đề cập riêng trong tài liệu này.
Các khuyến nghị về thời hạn sử dụng của dung dịch thuốc thử được chuẩn bị và sử dụng trong phòng thí nghiệm và được trình bày trong tài liệu này được thiết lập dựa trên dữ liệu khoa học (bao gồm dữ liệu xác nhận thu được từ biểu đồ kiểm soát chất lượng, hướng dẫn, tiêu chuẩn, dược điển, ấn phẩm, v.v.) và trên phân tích. kinh nghiệm và kiến thức về OMCL. Thời gian chuẩn bị, chi phí, chính sách quản lý chất thải bền vững và các mối quan tâm về bảo vệ môi trường cũng được xem xét trong quá trình chuẩn bị các khuyến nghị này.
Các khuyến nghị về thời hạn sử dụng của các dung dịch thuốc thử được cung cấp ở đây sẽ cho phép các phòng thí nghiệm đánh giá liệu một dung dịch nhất định có thể được sử dụng một cách an toàn và đáng tin cậy hay không (với điều kiện là các điều kiện bảo quản tuân thủ các yêu cầu) khi chúng tính đến các yếu tố khác nhau góp phần làm giảm chất lượng của một số thuốc thử (nhiệt độ, tiếp xúc với không khí, độ ẩm).
The document discusses comparison of dissolution profiles through different methods and establishing an IVIVC (in vitro-in vivo correlation). It provides definitions of dissolution profile and objectives of comparing profiles. Various methods for comparing profiles are described, including graphical, statistical, and model-dependent/independent methods. Key factors for determining similarity between dissolution profiles using statistical methods like difference factor and similarity factor are outlined. The importance of developing an IVIVC to reduce costs and the need for bioavailability studies is also mentioned. A research article comparing different brands of metformin tablets using tests like dissolution rate, drug content and disintegration is briefly summarized.
This document discusses stability testing and guidelines for conducting stability studies. It provides definitions and purposes of stability testing, including determining a product's shelf life and suitable storage conditions. Key points:
- Stability testing involves studying how a drug's quality changes over time under environmental factors like temperature, humidity, and light.
- Studies are conducted according to ICH guidelines and involve long-term, accelerated, and intermediate storage conditions on multiple batches.
- Results provide evidence for a retest period or shelf life. Significant changes observed during testing may require adjusting the proposed shelf life.
- Guidelines cover topics like selection of batches, containers, testing frequency, evaluation of results, and data presentation required in applications. Matrix
Similar to Role of bracketing & matrixing during stability study (20)
The University of Tartu certified that Md Selim Reza, born December 1, 1980, completed a 52-hour continuing education program called "LC-MS Method Validation" from November 27, 2018 to February 8, 2019. The certificate was issued on February 8, 2019 and signed by the Deputy Head of the Office of Academic Affairs and the Programme Director for Continuing Education.
Md selim reza_supplement_to_completion_certificateMD. SELIM REZA
This document is a certificate summarizing Md Selim Reza's completion of a 52-hour continuing education programme on LC-MS Method Validation from November 27, 2018 to February 8, 2019. It was issued by Tiia Ristolainen, Deputy Head of the Office of Academic Affairs and Esta Pilt, Programme Director for Continuing Education. The course covered topics like selectivity, linearity, precision, trueness, accuracy, stability, detection limits, ruggedness and robustness. Upon successful completion, participants would understand key method performance parameters, be able to design validation experiments and assessments, and evaluate a method's fitness for its intended purpose based on the validation results. Md Selim Reza received an
Discovering science-science-writing certificate-of_achievement_mv2ayqeMD. SELIM REZA
Md. Selim Reza completed a two-week course called "Discovering Science: Science Writing" from the University of Leeds. The course explored how to structure narratives and convey messages using different writing formats for science writing. It also covered topics like interview techniques and using video to communicate scientific information to various audiences. The course aimed to explain different types of science writing and help students develop news articles, blog posts, or video scripts about science.
ICH 7- GMP Guidance for API-questions & answersMD. SELIM REZA
This document provides clarification on uncertainties regarding the interpretation of certain sections of the ICH Q7 guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients. It answers questions on applying GMP to manufacturing steps before and after the defined API starting material. It also addresses questions on applying GMP to steps that add substances to stabilize an API, and clarifies that ICH Q7 should be applied to mixtures classified as an API.
What is TOC & why it's measurement in production process usable water is important in the pharmaceutical industrial environment in respect to product quality
WHO Guidance on Model Certificate of Analysis (COA)MD. SELIM REZA
WHO guided Model Certificate of Analysis (COA) for pharmaceuticals/Chemical industries/API Manufacturers to submit dosier for export regulatory market or in-house release purposes.
Guidelines for Preparing Laboratory Information FileMD. SELIM REZA
This document provides guidelines for preparing a Laboratory Information File (LIF) to describe the operations of pharmaceutical quality control laboratories. The LIF should include 13 sections that describe: general laboratory information; quality management systems; documentation control; personnel; premises; equipment; materials; subcontracting; sample handling; validation; out-of-specification investigations; stability testing; and microbiological testing, if applicable. The LIF is intended to be a concise yet comprehensive reference of approximately 30 pages that outlines all relevant aspects of the laboratory's quality system and operations.
QMS for setting a coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance.
To cater a green environment of manufacturing industries, reponsible persons or designee, higher management, owners should go through it and implement as required as their scope for safety, health, profitable business to global customer response.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Role of bracketing & matrixing during stability study
1. European Medicines Agency
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Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40
E-mail: mail@emea.eu.int http://www.emea.eu.int
EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
February 2002
CPMP/ICH/4104/00
ICH Topic Q 1 D
Bracketing and Matrixing designs for Stability Testing of Drug Substances and Drug
Products
Step 5
NOTE FOR GUIDANCE ON
BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF
DRUG SUBSTANCES AND DRUG PRODUCTS
(CPMP/ICH/4104/00)
TRANSMISSION TO CPMP November 2000
TRANSMISSION TO INTERESTED PARTIES November 2000
DEADLINE FOR COMMENTS March 2001
FINAL APPROVAL BY CPMP February 2002
DATE FOR COMING INTO OPERATION August 2002