The document discusses forced degradation studies which are used to assess the stability of drug substances and products and develop stability indicating analytical methods. Forced degradation involves subjecting drug samples to extreme chemical and environmental conditions to purposefully degrade the drug. This helps identify possible degradation pathways and products. The document outlines experimental designs for forced degradation studies on both solid and solution drug substances involving heat, humidity, light, acid/base hydrolysis, and oxidation. It emphasizes the need for appropriate forced degradation studies to develop stability indicating analytical methods.
MED-01 Medical Packaging Tester is professionally applicable to the determination of force properties of various medical packaging materials, with high precision (better than 0.5% of reading accuracy) and multiple test ranges. The instrument is designed with 16 independent test modes and bidirectional test mode of stretching and compression, which can meet various test requirements.
This study characterized a modified release multiparticulate tablet formulation consisting of acetaminophen-loaded beads and placebo beads. Acetaminophen beads containing 40-60% ethylcellulose and placebo beads containing 30% calcium silicate were developed using extrusion-spheronization. Tablets were compressed containing a 50:50 mixture of the drug and placebo beads. The drug beads released acetaminophen over 2 hours while the tablet formulation provided modified release up to 5 hours, though some coating damage occurred during compression.
1) A simple and sensitive UV spectrophotometric method was developed and validated for the quantitative analysis of sodium risedronate. The method was linear over the concentration range of 2-120 μg/ml.
2) Forced degradation studies were conducted according to ICH guidelines including acid, base, oxidation, thermal and photolytic conditions. Sodium risedronate was found to degrade under acid, base, oxidation and thermal stress but was stable to photolytic conditions.
3) The developed and validated stability-indicating UV method can be applied for the routine analysis of sodium risedronate in raw materials and pharmaceutical formulations.
Modeling and simulation has impacted drug development decision-making by allowing evaluation of different study designs, doses, and regimens using computer simulations. For a potential Alzheimer's drug, trial simulations were used to compare different study designs and select a 4x4 Latin square design with 4-week treatment periods. This design was predicted to have the best power to detect drug effects and correctly characterize the dose-response relationship. In another example, population PK/PD modeling of gabapentin clinical trial data supported the drug's efficacy in neuropathic pain at 1800 mg and 2400 mg daily doses.
GSK approach to enhancing process understanding using DynoChem: reaction kine...Scale-up Systems
The document describes GSK's use of Dynochem software to build a kinetic model for a homogeneous reaction involving Pleuromutilin. Experimental data was collected for the reaction at different temperatures and acid concentrations. Dynochem was used to develop a reaction scheme, fit kinetic parameters, and refine the model. The optimized model with 3 reactions provided the best fit to the experimental data and can be used to characterize the effects of temperature and acid on the reaction.
This document provides a list of 10 core assays for testing compounds that modulate the immune system. The assays measure things like cell proliferation, nitric oxide release from macrophages, and cytokine release from splenocytes or human PBMCs in response to test compounds. Each assay is described in terms of the test model, turnaround time, minimum compound requirement, and standard reporting format. The assays will help optimize leads for anti-inflammatory, pro-inflammatory, or other immunomodulatory activities.
These presentations are compiled by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM, WHO and similar organizations.
This document provides a list of 10 in vitro cell-based assays for testing compounds that may have effects related to immunomodulation. Each assay tests the effect of compounds on various cell-mediated immune responses such as cell proliferation, cytokine or nitric oxide release from murine or human cells. The assays would allow screening of up to 3-4 compounds per assay at multiple concentrations to determine potency and optimize leads for anti-inflammatory or pro-inflammatory activity over a 4 week period. Standard reporting includes Word reports with raw data also provided in Excel files.
MED-01 Medical Packaging Tester is professionally applicable to the determination of force properties of various medical packaging materials, with high precision (better than 0.5% of reading accuracy) and multiple test ranges. The instrument is designed with 16 independent test modes and bidirectional test mode of stretching and compression, which can meet various test requirements.
This study characterized a modified release multiparticulate tablet formulation consisting of acetaminophen-loaded beads and placebo beads. Acetaminophen beads containing 40-60% ethylcellulose and placebo beads containing 30% calcium silicate were developed using extrusion-spheronization. Tablets were compressed containing a 50:50 mixture of the drug and placebo beads. The drug beads released acetaminophen over 2 hours while the tablet formulation provided modified release up to 5 hours, though some coating damage occurred during compression.
1) A simple and sensitive UV spectrophotometric method was developed and validated for the quantitative analysis of sodium risedronate. The method was linear over the concentration range of 2-120 μg/ml.
2) Forced degradation studies were conducted according to ICH guidelines including acid, base, oxidation, thermal and photolytic conditions. Sodium risedronate was found to degrade under acid, base, oxidation and thermal stress but was stable to photolytic conditions.
3) The developed and validated stability-indicating UV method can be applied for the routine analysis of sodium risedronate in raw materials and pharmaceutical formulations.
Modeling and simulation has impacted drug development decision-making by allowing evaluation of different study designs, doses, and regimens using computer simulations. For a potential Alzheimer's drug, trial simulations were used to compare different study designs and select a 4x4 Latin square design with 4-week treatment periods. This design was predicted to have the best power to detect drug effects and correctly characterize the dose-response relationship. In another example, population PK/PD modeling of gabapentin clinical trial data supported the drug's efficacy in neuropathic pain at 1800 mg and 2400 mg daily doses.
GSK approach to enhancing process understanding using DynoChem: reaction kine...Scale-up Systems
The document describes GSK's use of Dynochem software to build a kinetic model for a homogeneous reaction involving Pleuromutilin. Experimental data was collected for the reaction at different temperatures and acid concentrations. Dynochem was used to develop a reaction scheme, fit kinetic parameters, and refine the model. The optimized model with 3 reactions provided the best fit to the experimental data and can be used to characterize the effects of temperature and acid on the reaction.
This document provides a list of 10 core assays for testing compounds that modulate the immune system. The assays measure things like cell proliferation, nitric oxide release from macrophages, and cytokine release from splenocytes or human PBMCs in response to test compounds. Each assay is described in terms of the test model, turnaround time, minimum compound requirement, and standard reporting format. The assays will help optimize leads for anti-inflammatory, pro-inflammatory, or other immunomodulatory activities.
These presentations are compiled by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM, WHO and similar organizations.
This document provides a list of 10 in vitro cell-based assays for testing compounds that may have effects related to immunomodulation. Each assay tests the effect of compounds on various cell-mediated immune responses such as cell proliferation, cytokine or nitric oxide release from murine or human cells. The assays would allow screening of up to 3-4 compounds per assay at multiple concentrations to determine potency and optimize leads for anti-inflammatory or pro-inflammatory activity over a 4 week period. Standard reporting includes Word reports with raw data also provided in Excel files.
High hydrostatic pressure between 500-4000 bar can disaggregate and refold proteins while maintaining native structure. This "PreEMT" technology enables refolding of inclusion bodies and aggregates from bacterial and mammalian expression into properly folded monomers. Studies show refolded interferon-beta and growth hormone had reduced aggregates and immunogenicity compared to commercially available versions. The technology is scalable and can improve safety and yields of protein therapeutics.
The document discusses terminology, objectives, types, protocols, and procedures for drug substance stability studies. It defines key terms like re-test date and period. It describes the three types of studies - accelerated, intermediate, and long term. It outlines the stability protocol including batch selection, storage conditions, testing frequency, and commitments. It also discusses stress testing to identify degradation products and evaluate the stability of molecules under various challenge conditions.
This document discusses techniques for preparing pharmaceutical samples for analysis. It covers sample types like tablets, capsules, and biological samples. The key goals of sample preparation are to get the analyte concentration within the instrument's measurement range, remove interfering compounds, achieve high and reproducible recovery, and ensure stability of the analyte until analysis. Common techniques include dissolution, dilution, extraction, and precipitation. The sample solvent selected must be compatible with the analytical method used.
Differential scanning calorimetry (DSC) can be used to quickly predict the storage stability of enzymes in liquid detergents. DSC measures the thermal stability of enzymes by determining the temperature at which they denature (Tm). Higher Tm values indicate better thermal stability. DSC studies found that enzymes are less stable in liquid detergents than buffers, and stability decreases with increasing hydrotrope concentration or changing surfactants. Adding known stabilizers like glycerol increased Tm and correlated with improved long-term stability. Thus DSC provides a fast way to screen enzyme and detergent formulations for thermal stability.
A simple rp hplc method for simultaneous analysis of pseudoephedrine, bambute...ijsidonlineinfo
This document describes the development and validation of a reverse phase HPLC method for the simultaneous analysis of Pseudoephedrine, Bambuterol, Levocetirizine, and Montelukast in pharmaceutical dosage forms. The method uses a C18 column with a gradient mobile phase of buffer and acetonitrile at a flow rate of 1 mL/min. The compounds were well separated with retention times between 4.1-21.1 minutes. The method was validated for linearity, precision, accuracy and robustness according to ICH guidelines and is suitable for quality control of these drugs in tablets and other dosage forms.
Risk reduction in tablet dosage form development and manufacturingDipankar Dey
This article describes how measuring material properties that
relate directly to the final tablet product, including the inherent
ability of materials to form tablets (compressibility) reduces the
overall risk in tablet development and manufacture. A case
study illustrates the benefits of rapid compressibility assessment.
Canadian Palestinian Professional Foundation Gala - 2016MEDIAinTORONTO
The document summarizes the 4th annual gala event of the Canadian Palestinian Professional Foundation (CPPF) held on September 8th, 2018 in Toronto. The event celebrated Palestinian culture and the foundation's achievement in preserving Palestinian heritage and culture. It provided scholarships to Palestinian students worldwide funded through various programs. The foundation's goals are to assist Palestinian students and promote the Palestinian community in Canada. The event included welcoming remarks, performances, award presentations, and thanks to sponsors and donors for their support in helping Palestinian students achieve their educational goals.
El resumen del caso es el siguiente:
1) adidas buscó potenciar su liderazgo en running y organizar la mayor prueba nacional de maratón en Chile con la ayuda de la agencia Strategika.
2) Strategika diseñó una estrategia para convertir el Maratón de Santiago en "la gran fiesta deportiva de la ciudad" y motivar a la población a salir a las calles a apoyar a los corredores.
3) El Maratón de Santiago se ha consolidado como la principal prueba de maratón en Chile y una de las
This document discusses preformulation and various analytical techniques used for drug-excipient compatibility studies. It describes types of incompatibilities like physical and chemical incompatibilities. Techniques discussed include thermal analysis methods like thermogravimetry (TG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). Other techniques mentioned are X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). The document also covers limitations of thermal analysis and applications of these techniques in preformulation studies like characterization of hydrates/solvates, detection of impurities, and compatibility 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.
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...MilliporeSigma
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...Merck Life Sciences
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
The document discusses terminology, objectives, types, protocols, and procedures for drug substance stability studies. It defines key terms like re-test date and period. It describes the three types of studies - accelerated, intermediate, and long term. It outlines the stability protocol including batch selection, storage conditions, testing frequency, and commitments. It also discusses stress testing to identify degradation products and evaluate the stability of molecules under various challenge conditions.
Three analytical techniques are essential for effectively evaluating the stability of monoclonal antibodies (MABs):
1. Size-exclusion chromatography provides quantification of MAB monomers and aggregates as well as purity assessment. Validation is needed to establish linearity, accuracy, precision, and robustness.
2. Dynamic light scattering characterizes polydispersity and size distributions to detect aggregation. It can resolve oligomers and high molecular weight aggregates.
3. Microflow imaging counts and characterizes insoluble particles above 1um, 2um, and 10um, allowing separation of aggregates from air bubbles and oil droplets.
Together these techniques provide a stability-indicating profile to monitor changes in primary,
This document summarizes ICH guidelines for stability testing of drug substances and products. It discusses the key topics covered by ICH Q1 including stability protocols, studies at different storage conditions, evaluation of stability data, and design approaches like bracketing and matrixing. The guidelines provide recommendations for parameters to test at different timepoints under long term, intermediate, and accelerated conditions. Statistical analysis of batch variability is important to establish a retest or expiry date. Photostability testing and requirements for new dosage forms are also outlined. Overall the ICH Q1 guidelines aim to standardize stability testing practices to ensure quality, safety and efficacy of drugs over their shelf life.
ANALYTICAL METHOD VALIDATION BY P.RAVISANKAR Dr. Ravi Sankar
This document discusses analytical method validation. It begins with an introduction that defines validation and discusses its importance and regulatory requirements. The document then covers specific validation parameters such as specificity, linearity, accuracy, precision, limit of detection, limit of quantification and more. For each parameter, the document provides definitions, procedures for evaluation, and acceptance criteria. It emphasizes that validation demonstrates a method is suitable for its intended purpose and supports the identity, quality, purity and potency of drug substances and products. The overall summary is that analytical method validation is critical to ensure quality and compliance in the pharmaceutical industry.
High hydrostatic pressure between 500-4000 bar can disaggregate and refold proteins while maintaining native structure. This "PreEMT" technology enables refolding of inclusion bodies and aggregates from bacterial and mammalian expression into properly folded monomers. Studies show refolded interferon-beta and growth hormone had reduced aggregates and immunogenicity compared to commercially available versions. The technology is scalable and can improve safety and yields of protein therapeutics.
The document discusses terminology, objectives, types, protocols, and procedures for drug substance stability studies. It defines key terms like re-test date and period. It describes the three types of studies - accelerated, intermediate, and long term. It outlines the stability protocol including batch selection, storage conditions, testing frequency, and commitments. It also discusses stress testing to identify degradation products and evaluate the stability of molecules under various challenge conditions.
This document discusses techniques for preparing pharmaceutical samples for analysis. It covers sample types like tablets, capsules, and biological samples. The key goals of sample preparation are to get the analyte concentration within the instrument's measurement range, remove interfering compounds, achieve high and reproducible recovery, and ensure stability of the analyte until analysis. Common techniques include dissolution, dilution, extraction, and precipitation. The sample solvent selected must be compatible with the analytical method used.
Differential scanning calorimetry (DSC) can be used to quickly predict the storage stability of enzymes in liquid detergents. DSC measures the thermal stability of enzymes by determining the temperature at which they denature (Tm). Higher Tm values indicate better thermal stability. DSC studies found that enzymes are less stable in liquid detergents than buffers, and stability decreases with increasing hydrotrope concentration or changing surfactants. Adding known stabilizers like glycerol increased Tm and correlated with improved long-term stability. Thus DSC provides a fast way to screen enzyme and detergent formulations for thermal stability.
A simple rp hplc method for simultaneous analysis of pseudoephedrine, bambute...ijsidonlineinfo
This document describes the development and validation of a reverse phase HPLC method for the simultaneous analysis of Pseudoephedrine, Bambuterol, Levocetirizine, and Montelukast in pharmaceutical dosage forms. The method uses a C18 column with a gradient mobile phase of buffer and acetonitrile at a flow rate of 1 mL/min. The compounds were well separated with retention times between 4.1-21.1 minutes. The method was validated for linearity, precision, accuracy and robustness according to ICH guidelines and is suitable for quality control of these drugs in tablets and other dosage forms.
Risk reduction in tablet dosage form development and manufacturingDipankar Dey
This article describes how measuring material properties that
relate directly to the final tablet product, including the inherent
ability of materials to form tablets (compressibility) reduces the
overall risk in tablet development and manufacture. A case
study illustrates the benefits of rapid compressibility assessment.
Canadian Palestinian Professional Foundation Gala - 2016MEDIAinTORONTO
The document summarizes the 4th annual gala event of the Canadian Palestinian Professional Foundation (CPPF) held on September 8th, 2018 in Toronto. The event celebrated Palestinian culture and the foundation's achievement in preserving Palestinian heritage and culture. It provided scholarships to Palestinian students worldwide funded through various programs. The foundation's goals are to assist Palestinian students and promote the Palestinian community in Canada. The event included welcoming remarks, performances, award presentations, and thanks to sponsors and donors for their support in helping Palestinian students achieve their educational goals.
El resumen del caso es el siguiente:
1) adidas buscó potenciar su liderazgo en running y organizar la mayor prueba nacional de maratón en Chile con la ayuda de la agencia Strategika.
2) Strategika diseñó una estrategia para convertir el Maratón de Santiago en "la gran fiesta deportiva de la ciudad" y motivar a la población a salir a las calles a apoyar a los corredores.
3) El Maratón de Santiago se ha consolidado como la principal prueba de maratón en Chile y una de las
This document discusses preformulation and various analytical techniques used for drug-excipient compatibility studies. It describes types of incompatibilities like physical and chemical incompatibilities. Techniques discussed include thermal analysis methods like thermogravimetry (TG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). Other techniques mentioned are X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). The document also covers limitations of thermal analysis and applications of these techniques in preformulation studies like characterization of hydrates/solvates, detection of impurities, and compatibility 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.
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...MilliporeSigma
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
Hot melt extrusion with PVA – solubility enhancement, supersaturation perform...Merck Life Sciences
Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs).
In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development.
A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations.
This webinar includes:
- The current status and further potential of HME in pharmaceutical industry
- Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options
- Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions
In this webinar, you will learn:
- which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA)
- why PVA is more than just a polymer
- how to create your final dosage form and speed up your formulation development
The document discusses terminology, objectives, types, protocols, and procedures for drug substance stability studies. It defines key terms like re-test date and period. It describes the three types of studies - accelerated, intermediate, and long term. It outlines the stability protocol including batch selection, storage conditions, testing frequency, and commitments. It also discusses stress testing to identify degradation products and evaluate the stability of molecules under various challenge conditions.
Three analytical techniques are essential for effectively evaluating the stability of monoclonal antibodies (MABs):
1. Size-exclusion chromatography provides quantification of MAB monomers and aggregates as well as purity assessment. Validation is needed to establish linearity, accuracy, precision, and robustness.
2. Dynamic light scattering characterizes polydispersity and size distributions to detect aggregation. It can resolve oligomers and high molecular weight aggregates.
3. Microflow imaging counts and characterizes insoluble particles above 1um, 2um, and 10um, allowing separation of aggregates from air bubbles and oil droplets.
Together these techniques provide a stability-indicating profile to monitor changes in primary,
This document summarizes ICH guidelines for stability testing of drug substances and products. It discusses the key topics covered by ICH Q1 including stability protocols, studies at different storage conditions, evaluation of stability data, and design approaches like bracketing and matrixing. The guidelines provide recommendations for parameters to test at different timepoints under long term, intermediate, and accelerated conditions. Statistical analysis of batch variability is important to establish a retest or expiry date. Photostability testing and requirements for new dosage forms are also outlined. Overall the ICH Q1 guidelines aim to standardize stability testing practices to ensure quality, safety and efficacy of drugs over their shelf life.
ANALYTICAL METHOD VALIDATION BY P.RAVISANKAR Dr. Ravi Sankar
This document discusses analytical method validation. It begins with an introduction that defines validation and discusses its importance and regulatory requirements. The document then covers specific validation parameters such as specificity, linearity, accuracy, precision, limit of detection, limit of quantification and more. For each parameter, the document provides definitions, procedures for evaluation, and acceptance criteria. It emphasizes that validation demonstrates a method is suitable for its intended purpose and supports the identity, quality, purity and potency of drug substances and products. The overall summary is that analytical method validation is critical to ensure quality and compliance in the pharmaceutical industry.
Similar to Anabiotec presentation forced degradation (8)
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
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.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
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1. Integration of Forced Degradation Study in
LC Stability Indicating Method Development
Katy Dewitte, Ph.D. Pharm
Knowledge Manager, Anabiotec
1
2. Introduction Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Today’s Agenda
Forced degradation: definition and principles
The stability indicating power of an analytical method
Experimental design to conduct a study
Practical example: case study
Challenging the stability indicating method
Conclusion
2
3. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Definition of forced degradation or stress testing
The process of subjecting drug compounds:
DRUG SUBSTANCE
DRUG PRODUCT
PLACEBO
…
to extreme chemical and environmental conditions.
3
4. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
3 main purposes (according to ICH and FDA):
To provide a stability assessment of the drug substance (DS) or
drug product (DP), to determine the intrinsic stability of a molecule
To elucidate the possible degradation pathways of the DS or the
API in the DP (by identifying the likely degradation products)
To investigate the stability indicating power of the analytical
method applied for DS and DP.
4
5. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
A stability indicating method:
is a validated, quantitative analytical procedure
can detect the changes with time in the pertinent properties of the
drug substance and drug product; is able to detect the increase in
degradation products.
measures accurately the active ingredients without interference
from degradation products, process impurities, excipients, or
other potential impurities (specificity)
5
6. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Development of a stability indicating method:
Purpose of forced degradation studies:
Formation of potential degradation products
Purposeful degradation
Which degradation products can be expected during storage and
stability studies?
Need for appropriate forced degradation studies!
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7. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
4 main degradation mechanisms:
Heat (thermolytic degradation)
Hydrolytic degradation
Oxidative degradation
Photolytic degradation
Degrade the drug by ± 10%, or slightly exceeding the accelerated
stability conditions
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9. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solid
Light, 1 X ICH
Photolysis Light, 3 X ICH
Heat Light control
Heat + humidity
9
10. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solid
More severe than accelerated
(40°C / 75%RH)
Photolysis 60°C or 80°C
Heat 1, 3 and 5 days
Heat + humidity
10
11. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solid
More severe than accelerated
(40°C / 75%RH)
Photolysis 60°C / 75%RH or
aa80°C / 75%RH
Heat
1, 3 and 5 days
Heat + humidity
11
12. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solution /
Suspension
Light, 1 X ICH
Light, 3 X ICH Photolysis
Light control Acid/base hydrolysis
Oxidation
12
13. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solution /
Solutions at various pH (2-12) Suspension
0.1M – 1M HCl
0.1M – 1M NaOH Photolysis
Room temperature or elevated Acid/base hydrolysis
1, 3 and 5 days Oxidation
13
14. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Drug Substance
Solution /
Suspension
0.1% – 3% H2O2
Metal ions
Photolysis
Radical initiators
Acid/base hydrolysis
1, 3 and 5 days
Oxidation
14
15. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Case: A new drug substance (early phase)
Step 1: Development of a (stability indicating?) method
0.060
0.050
2 .0 0
0.040
1 .8 0 0.030
0.020
1 .6 0 0.010
AU
0.000
1 .4 0
-0.010
-0.020
1 .2 0
-0.030
AU
-0.040
1 .0 0
-0.050
0 .8 0 -0.060
3. 00 4. 00 5.00 6.00 7.00 8.00 9.00 10.00 11.00 12.00 13.00 14.00 15.00 16.00 17.00
Minutes
0 .6 0
0 .4 0
0 .2 0
0 .0 0
0 .0 0 2 .0 0 4 .0 0 6 .0 0 8 .0 0 1 0 .0 0 1 2 .0 0 1 4 .0 0 1 6 .0 0 1 8 .0 0 2 0 .0 0
M in u t e s
15
16. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Quality-by-design approach
Software based development of an analytical method
DS
Starting materials
Degradants
Synthesis impurities
A stressed DS sample (if any information is available)
16
17. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Quality-by-design approach
17
18. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Quality-by-design approach
18
33. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Conclusion of the case study
The method developed with the initial information is already very
suitable for conducting forced degradation experiments.
Full data from the 4 stress mechanisms indicate if additional method
optimization is needed.
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34. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Conclusion
Power Method
Conclusion of the case study
Consider the guidelines: only degradants that will be expected under
normal storage conditions must be taken into account.
Fit for purpose combined with Quality-by-design approach reduces the
workload and pass-through time.
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35. Forced Degradation Stability Indicating Experimental Design Practical Example Stability Indicating Acknowledgement
Power Method
Acknowledgement
Mr. Herman Nuytten, CSO of AnaBioTec
Mrs. Ineke Verweire, COO of AnaBioTec
The project managers from AnaBioTec
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