Physicochemical and biological properties of sustained release formulationsSonam Gandhi
This document discusses factors that influence the biological performance of sustained drug release formulations (SDRFs). It outlines five key factors: 1) aqueous solubility, 2) partition coefficient, 3) drug stability, 4) protein binding, and 5) molecular size and diffusivity. It then examines how these factors impact absorption, distribution, metabolism, elimination, and biological half-life of drugs from SDRFs. Specifically, it notes how these pharmacokinetic properties must be considered to minimize side effects and control plasma drug concentrations over time.
This document discusses the key aspects of technology transfer between a sending unit and receiving unit. It outlines the types of documentation, analytical methods, equipment, and facilities information that should be provided to properly transfer a manufacturing process. This includes details on APIs, excipients, finished products, packaging, cleaning procedures, and quality control testing. The roles and responsibilities of both units are defined to ensure a successful technology transfer.
This document summarizes a seminar on gastroretentive drug delivery systems (GRDDS). GRDDS are designed to retain drugs in the stomach for prolonged periods of time to allow for sustained drug release. The seminar outlines various GRDDS technologies including floating, swelling, mucoadhesive, and high density systems. It also discusses candidate drugs for GRDDS, advantages like improved bioavailability, and evaluation methods like dissolution testing, floating time, and mucoadhesive strength testing. Limitations include instability at gastric pH and requirement of high fluid levels for floating systems.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
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
Physicochemical and biological properties of sustained release formulationsSonam Gandhi
This document discusses factors that influence the biological performance of sustained drug release formulations (SDRFs). It outlines five key factors: 1) aqueous solubility, 2) partition coefficient, 3) drug stability, 4) protein binding, and 5) molecular size and diffusivity. It then examines how these factors impact absorption, distribution, metabolism, elimination, and biological half-life of drugs from SDRFs. Specifically, it notes how these pharmacokinetic properties must be considered to minimize side effects and control plasma drug concentrations over time.
This document discusses the key aspects of technology transfer between a sending unit and receiving unit. It outlines the types of documentation, analytical methods, equipment, and facilities information that should be provided to properly transfer a manufacturing process. This includes details on APIs, excipients, finished products, packaging, cleaning procedures, and quality control testing. The roles and responsibilities of both units are defined to ensure a successful technology transfer.
This document summarizes a seminar on gastroretentive drug delivery systems (GRDDS). GRDDS are designed to retain drugs in the stomach for prolonged periods of time to allow for sustained drug release. The seminar outlines various GRDDS technologies including floating, swelling, mucoadhesive, and high density systems. It also discusses candidate drugs for GRDDS, advantages like improved bioavailability, and evaluation methods like dissolution testing, floating time, and mucoadhesive strength testing. Limitations include instability at gastric pH and requirement of high fluid levels for floating systems.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Scale up and post approval changes(supac)bdvfgbdhg
The document discusses guidelines for post-approval changes to drug products, including changes to batch size, manufacturing sites and equipment, and composition. It outlines 3 levels of changes - minor, moderate, and major - and provides recommendations for documentation and regulatory filings required for each level of change. Major changes, such as a new manufacturing site or changes in the amount of active ingredients, require more extensive documentation including stability testing and possibly bioequivalence studies.
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
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
The document discusses Supplemental Abbreviated Changes to an Approved Application (SUPAC) guidelines for post-approval changes to pharmaceutical drug products. It defines three levels of changes - minor, moderate, and major - and provides recommendations for documentation and necessary filings based on the level of change for components/composition, manufacturing equipment, processes, batch size, and site changes. Minor changes may only require annual reporting, while major changes involving new excipients, processes, or sites would necessitate prior approval supplements and additional testing.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
This document discusses the design and scale up considerations of pilot plants for tablet manufacturing. It begins by defining a pilot plant and its significance in transforming a lab-scale formula into a viable product. The objectives of the pilot plant include producing stable dosage forms, identifying critical process features, and providing information to support larger scale production. The document then discusses various unit operations involved in tablet manufacturing like material handling, blending, granulation, drying, milling, blending, compression, and coating. It provides details on equipment selection and process parameters that must be considered during scale up for each unit operation to ensure quality and reproducibility at production scale.
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTSuraj Pamadi
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The document discusses regulatory requirements for non-clinical drug development, including guidelines from the European Medicines Agency. It describes the types of non-clinical studies done in silico, in vitro, and in vivo to determine efficacy, safety, delivery methods, and manufacturing viability before clinical trials. Key submissions to regulators include the Investigational New Drug Application, New Drug Application, and Abbreviated New Drug Application.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
Technology development & transfer by devillSnake EYE
The document discusses key aspects of technology transfer between a sending unit and receiving unit. It defines technology transfer and lists requirements such as a documented approach, trained personnel, and quality documentation. It also defines terms related to quality assurance in technology transfer, including active pharmaceutical ingredients, good manufacturing practices, process validation, and more. Finally, it provides guidance on aspects of technology transfer including developing a transfer protocol, specifications for starting materials, and information that should be transferred about APIs and excipients.
This document discusses FDA's efforts to standardize regulatory data submissions through the use of data standards and the Janus initiative. It provides background on the large and growing volumes of submissions received by FDA. It then describes the challenges of disparate data formats and lack of standards. The vision is outlined for a standardized approach using exchange standards like SDTM and terminology standards. The Janus initiative aims to create a centralized data infrastructure within FDA to improve management and analysis of scientific data submissions and help modernize the review process.
Evaluation of transdermal drug delivery systemSagar Savale
This document discusses the evaluation of transdermal drug delivery systems. Key aspects that are evaluated include physicochemical properties, adhesive properties, in vitro studies, in vivo studies, stability studies, and toxicological studies. These evaluations are important to ensure consistency between batches in terms of quality, performance, reproducibility and stability, and to predict factors that may influence drug delivery.
Investigational new drug application (ind)Siddu K M
The document provides an overview of the Investigational New Drug Application (IND) process. An IND is required before beginning clinical trials of an unapproved drug and provides the FDA with data to assess risks to human subjects. The IND application includes a cover sheet, table of contents, general investigation plan, investigators brochure outlining the clinical protocol, chemistry and manufacturing data, pharmacological/toxicological data, and information on previous human exposure. It describes the content and format requirements for an IND as specified in 21 CFR part 312 regulations. The IND allows companies to initiate clinical studies of new drug products and obtain marketing approval.
Non clinical drug development (Investigational Medicinal Product, IMPD) By Pr...PRAJAKTASAWANT33
The document presents information on regulatory requirements for investigational medicinal products (IMPs) and investigational medicinal product dossiers (IMPDs) in the European Union. It defines an IMP as a pharmaceutical product used in a clinical trial, including products with marketing authorization being tested differently than approved. A full or simplified IMPD must be submitted and approved as part of a clinical trial authorization application. The IMPD contains quality, non-clinical and clinical data about the IMP to assess risks and benefits before trials.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.
This document discusses mucoadhesive drug delivery systems (MDDS). It begins by defining MDDS as drug delivery systems that interact with mucus layers and increase drug residence time at absorption sites. It then discusses various types of MDDS (buccal, sublingual, etc.), advantages like prolonged drug effects, and challenges like irritation. The document also covers mucoadhesion theories, drug transport mechanisms, formulation considerations, and provides an example case study on salbutamol sulfate buccal patches.
This document discusses in vitro dissolution testing methods. It defines dissolution as the process by which a solid substance solubilizes in a solvent, and dissolution rate as the amount of drug substance that goes into solution per unit time under standardized conditions. It then describes 7 common apparatus used for in vitro dissolution testing according to pharmacopeial standards, including the rotating basket, paddle, reciprocating cylinder, flow through cell, paddle over disk, rotating cylinder, and reciprocating disk methods. Each apparatus has distinct advantages and disadvantages for testing different drug products and dosage forms.
This document discusses various parameters used to characterize drug release from pharmaceutical formulations, including diffusion parameters described by Higuchi's equation, dissolution parameters like the effects of agitation and pH, and pharmacokinetic parameters like Cmax, Tmax, and AUC. It also covers models like the Heckel equation that can be applied to understand powder compaction and the Korsmeyer-Peppas model for characterizing drug release mechanisms.
This document discusses bioavailability and bioequivalence studies. It defines bioavailability as the amount of drug that reaches systemic circulation in an unchanged form. Bioequivalence studies compare the test and reference formulations to show they have the same rate and extent of absorption. The document outlines study design considerations and parameters assessed, including Cmax, Tmax, and AUC from plasma concentration data. It also discusses single and multiple dose studies, as well as parallel and crossover study designs used in bioequivalence testing.
The document discusses bioavailability studies, which determine the efficiency of drug absorption from different dosage forms and formulations. Key aspects covered include:
- Objectives of bioavailability studies such as determining the influence of excipients and other drugs on absorption during new drug development.
- Factors affecting bioavailability including drug properties, dosage form characteristics, and patient-related factors.
- Methods of measuring bioavailability including plasma concentration-time curves and urinary drug excretion.
- The importance of correlating in vitro dissolution tests to in vivo absorption through levels of in vitro-in vivo correlation (IVIVC).
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
The document discusses Indian regulatory requirements for drugs, including the Central Drugs Standard Control Organization (CDSCO) which regulates drugs, cosmetics, diagnostics and devices in India. CDSCO is headed by the Drug Controller General of India and oversees functions like new drug approval, clinical trials, good manufacturing practices, and state licensing. It provides an overview of the application and approval process for new drugs in India.
The document discusses Supplemental Abbreviated Changes to an Approved Application (SUPAC) guidelines for post-approval changes to pharmaceutical drug products. It defines three levels of changes - minor, moderate, and major - and provides recommendations for documentation and necessary filings based on the level of change for components/composition, manufacturing equipment, processes, batch size, and site changes. Minor changes may only require annual reporting, while major changes involving new excipients, processes, or sites would necessitate prior approval supplements and additional testing.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
This document discusses the design and scale up considerations of pilot plants for tablet manufacturing. It begins by defining a pilot plant and its significance in transforming a lab-scale formula into a viable product. The objectives of the pilot plant include producing stable dosage forms, identifying critical process features, and providing information to support larger scale production. The document then discusses various unit operations involved in tablet manufacturing like material handling, blending, granulation, drying, milling, blending, compression, and coating. It provides details on equipment selection and process parameters that must be considered during scale up for each unit operation to ensure quality and reproducibility at production scale.
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCTSuraj Pamadi
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The document discusses regulatory requirements for non-clinical drug development, including guidelines from the European Medicines Agency. It describes the types of non-clinical studies done in silico, in vitro, and in vivo to determine efficacy, safety, delivery methods, and manufacturing viability before clinical trials. Key submissions to regulators include the Investigational New Drug Application, New Drug Application, and Abbreviated New Drug Application.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
Technology development & transfer by devillSnake EYE
The document discusses key aspects of technology transfer between a sending unit and receiving unit. It defines technology transfer and lists requirements such as a documented approach, trained personnel, and quality documentation. It also defines terms related to quality assurance in technology transfer, including active pharmaceutical ingredients, good manufacturing practices, process validation, and more. Finally, it provides guidance on aspects of technology transfer including developing a transfer protocol, specifications for starting materials, and information that should be transferred about APIs and excipients.
This document discusses FDA's efforts to standardize regulatory data submissions through the use of data standards and the Janus initiative. It provides background on the large and growing volumes of submissions received by FDA. It then describes the challenges of disparate data formats and lack of standards. The vision is outlined for a standardized approach using exchange standards like SDTM and terminology standards. The Janus initiative aims to create a centralized data infrastructure within FDA to improve management and analysis of scientific data submissions and help modernize the review process.
Evaluation of transdermal drug delivery systemSagar Savale
This document discusses the evaluation of transdermal drug delivery systems. Key aspects that are evaluated include physicochemical properties, adhesive properties, in vitro studies, in vivo studies, stability studies, and toxicological studies. These evaluations are important to ensure consistency between batches in terms of quality, performance, reproducibility and stability, and to predict factors that may influence drug delivery.
Investigational new drug application (ind)Siddu K M
The document provides an overview of the Investigational New Drug Application (IND) process. An IND is required before beginning clinical trials of an unapproved drug and provides the FDA with data to assess risks to human subjects. The IND application includes a cover sheet, table of contents, general investigation plan, investigators brochure outlining the clinical protocol, chemistry and manufacturing data, pharmacological/toxicological data, and information on previous human exposure. It describes the content and format requirements for an IND as specified in 21 CFR part 312 regulations. The IND allows companies to initiate clinical studies of new drug products and obtain marketing approval.
Non clinical drug development (Investigational Medicinal Product, IMPD) By Pr...PRAJAKTASAWANT33
The document presents information on regulatory requirements for investigational medicinal products (IMPs) and investigational medicinal product dossiers (IMPDs) in the European Union. It defines an IMP as a pharmaceutical product used in a clinical trial, including products with marketing authorization being tested differently than approved. A full or simplified IMPD must be submitted and approved as part of a clinical trial authorization application. The IMPD contains quality, non-clinical and clinical data about the IMP to assess risks and benefits before trials.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.
This document discusses mucoadhesive drug delivery systems (MDDS). It begins by defining MDDS as drug delivery systems that interact with mucus layers and increase drug residence time at absorption sites. It then discusses various types of MDDS (buccal, sublingual, etc.), advantages like prolonged drug effects, and challenges like irritation. The document also covers mucoadhesion theories, drug transport mechanisms, formulation considerations, and provides an example case study on salbutamol sulfate buccal patches.
This document discusses in vitro dissolution testing methods. It defines dissolution as the process by which a solid substance solubilizes in a solvent, and dissolution rate as the amount of drug substance that goes into solution per unit time under standardized conditions. It then describes 7 common apparatus used for in vitro dissolution testing according to pharmacopeial standards, including the rotating basket, paddle, reciprocating cylinder, flow through cell, paddle over disk, rotating cylinder, and reciprocating disk methods. Each apparatus has distinct advantages and disadvantages for testing different drug products and dosage forms.
This document discusses various parameters used to characterize drug release from pharmaceutical formulations, including diffusion parameters described by Higuchi's equation, dissolution parameters like the effects of agitation and pH, and pharmacokinetic parameters like Cmax, Tmax, and AUC. It also covers models like the Heckel equation that can be applied to understand powder compaction and the Korsmeyer-Peppas model for characterizing drug release mechanisms.
This document discusses bioavailability and bioequivalence studies. It defines bioavailability as the amount of drug that reaches systemic circulation in an unchanged form. Bioequivalence studies compare the test and reference formulations to show they have the same rate and extent of absorption. The document outlines study design considerations and parameters assessed, including Cmax, Tmax, and AUC from plasma concentration data. It also discusses single and multiple dose studies, as well as parallel and crossover study designs used in bioequivalence testing.
The document discusses bioavailability studies, which determine the efficiency of drug absorption from different dosage forms and formulations. Key aspects covered include:
- Objectives of bioavailability studies such as determining the influence of excipients and other drugs on absorption during new drug development.
- Factors affecting bioavailability including drug properties, dosage form characteristics, and patient-related factors.
- Methods of measuring bioavailability including plasma concentration-time curves and urinary drug excretion.
- The importance of correlating in vitro dissolution tests to in vivo absorption through levels of in vitro-in vivo correlation (IVIVC).
The document discusses bioavailability and bioequivalence. It defines bioavailability as the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioequivalence is achieved when two drug products containing the same active ingredient have the same rate and extent of absorption. The document outlines factors that affect bioavailability such as pharmaceutical, patient, and route of administration factors. It also describes various methods to measure bioavailability including pharmacokinetic and pharmacodynamic approaches.
This document discusses bioavailability and bioequivalence studies. It defines bioavailability as the fraction of a drug that reaches systemic circulation, and bioequivalence as drugs reaching circulation at the same rate and to the same extent. It describes various methods to measure bioavailability including plasma level time studies, urinary excretion studies, and pharmacological or therapeutic response. The document outlines study designs for bioequivalence testing including randomization, cross-over, and Latin square designs. It discusses the importance of these studies for drug development and quality control.
This document discusses bioavailability and bioequivalence. It defines bioavailability as the rate and extent of absorption of an orally administered drug, which depends on factors like absorption and hepatic metabolism. Bioequivalence refers to similar bioavailability between formulations, and is determined by comparing AUC and Cmax values. The document outlines methods to assess bioavailability, including pharmacokinetic studies and dissolution testing, and factors that can influence bioavailability such as physiological, physicochemical, and pharmacological factors. It also discusses limitations of bioavailability and bioequivalence studies.
This document discusses bioavailability and bioequivalence of drug products. It defines key terms like bioavailability, bioequivalence, chemical equivalence and absolute/relative bioavailability. It describes objectives of bioavailability studies and methods of measuring bioavailability including pharmacokinetic methods like plasma level time studies and urinary excretion studies, and pharmacodynamic methods like acute pharmacological response and therapeutic response. It also discusses in vitro dissolution studies, IVIVC correlation, types of bioequivalence experimental study designs and statistical interpretation of bioequivalence data.
This document discusses guidelines for bioavailability and bioequivalence studies. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents and alternatives. It outlines when bioequivalence studies are necessary, such as for modified release drugs, and when they are not required, such as for parenteral solutions. It also describes the different types of studies including pharmacokinetic, pharmacodynamic and clinical endpoint studies. Finally, it provides details on study design, population, conditions and statistical evaluation for pharmacokinetic bioequivalence studies.
This document provides information on bioavailability and bioequivalence. It defines bioavailability as the rate and extent of absorption of a drug that reaches systemic circulation in an active form. Bioequivalence exists when the bioavailability of a drug is the same between different formulations. The document discusses factors affecting bioavailability and various methods to assess bioavailability such as pharmacokinetic and urinary excretion methods. It also covers dissolution testing, limitations of assessing bioavailability and bioequivalence, and the need to conduct bioequivalence studies.
General Pharmacology Lecture Slides on Bioavailability and Bioequivalence by Sanjaya Mani Dixit Assistant Professor of Pharmacology at Kathmandu Medical College
Bioavailability, Bioequivalence and BCS ClassificationVignan University
This document provides an overview of bioavailability, bioequivalence, and BCS classification. It defines key terms like bioavailability, absolute and relative bioavailability, and factors affecting bioavailability. Measurement methods like pharmacokinetic and pharmacodynamic approaches are discussed. Bioequivalence studies and their types are summarized. The six classes of BCS classification and its applications in drug development are highlighted in brief. In conclusion, the document notes that BCS classification provides guidance in drug formulation and review processes to reduce costs and time of approval.
Bioavailability & Bioequivalence ppt, Objectives, Improving bioavailability, Assessment of bioavailability, Urinary excretion studies, Blood serum studies, in vitro drug dissolution testing, need for dissolution testing, in vitro drug dissolution testing models, Bioequivalence, Therapeutic equivalence, Types of bioequivalence studies, Pharmacokinetic studies, Methods to enhance dissolution rate.
The key factors affecting drug absorption from oral formulations are drug solubility and dissolution rate. The two critical rate-determining steps are the rate of drug dissolution and the rate of permeation through the gastrointestinal membrane. Drug solubility and permeability classify drugs into four Biopharmaceutics Classification System classes. In vitro drug dissolution tests aim to maintain sink conditions to obtain a good correlation with in vivo absorption, such as by increasing fluid volume, partitioning dissolved drug, or adding solvents or adsorbents. Dissolution models account for changing surface area as particles dissolve over time.
The key factors affecting drug absorption from oral formulations are drug solubility and dissolution rate. The two critical rate-determining steps are the rate of drug dissolution and the rate of permeation through the gastrointestinal membrane. Drug solubility and permeability classify drugs into four Biopharmaceutics Classification System classes. In vitro drug dissolution tests aim to maintain sink conditions to obtain a good correlation with in vivo absorption, such as by increasing fluid volume, partitioning dissolved drug, or adding solvents or adsorbents. Dissolution models account for changing surface area as particles dissolve over time.
Estimation of pharmacokinetic parametersKarun Kumar
This document discusses key pharmacokinetic parameters that can be estimated including those related to absorption, distribution, and elimination of drugs in the body. It provides definitions and formulas for parameters such as bioavailability, absorption rate constant, volume of distribution, clearance, and half-life. Methods for measuring the area under the plasma concentration-time curve are also outlined. Factors that can influence bioavailability like pharmaceutical properties and physiological factors are briefly explained.
This document discusses bioavailability and factors that affect it. It defines bioavailability as the rate and extent to which an administered drug reaches systemic circulation. Factors that can impact bioavailability include pharmaceutical factors like drug properties and dosage form characteristics, patient factors like disease state and gastrointestinal contents, and route of administration. Methods for measuring bioavailability include pharmacokinetic methods using plasma concentration-time profiles or urinary excretion studies, pharmacodynamic methods assessing pharmacological or therapeutic responses, and scintigraphy studies. Approaches to enhance bioavailability involve modifying pharmaceutical, pharmacokinetic, or biological factors.
This document discusses bioavailability and factors affecting it. It defines bioavailability as the rate and extent of absorption of a drug into systemic circulation from its dosage form. Absolute bioavailability is the systemic availability of a drug after extravascular administration compared to intravenous dosing. Relative bioavailability compares the systemic availability of a drug after oral administration to that of an oral standard. The document then discusses primary stages of drug development, factors affecting subject selection in bioavailability studies, and methods of assessing bioavailability including pharmacokinetic, urinary excretion, and pharmacological response methods.
This document discusses bioavailability and bioequivalence. It defines bioavailability as the rate and extent of drug absorption into systemic circulation from its dosage form. Bioequivalence is established when two similar dosage forms reach systemic circulation at the same relative rate and extent. The objectives, significance, and various study designs of bioavailability testing are described, including absolute vs relative bioavailability. Methods for measuring bioavailability and various in vitro drug dissolution models are also summarized.
This document discusses drug bioavailability, which refers to the rate and extent to which an unchanged drug is absorbed into the bloodstream and made available at the site of action. It outlines different types of bioavailability, including absolute and relative bioavailability. Methods for assessing bioavailability are also presented, such as pharmacokinetic methods like plasma level analysis and urinary excretion data, as well as pharmacodynamic methods like measuring acute pharmacological response or therapeutic response. Factors that can influence bioavailability include the route of administration, patient characteristics, drug properties, and dosage form characteristics.
1.0.bioavailability, pharmacokinetics and efficacy determinationsalummkata1
Bioavailability is a measure of the rate and fraction of the initial dose of a drug that successfully reaches either; the site of action or the bodily fluid domain from which the drug’s intended targets have unimpeded access.
For majority purposes, bioavailability is defined as the fraction of the active form of a drug that reaches systemic circulation unaltered. This definition assumes 100% of the active drug that enters systemic circulation will successfully reach the target site. However, it should be appreciated that this definition is not inclusive of drugs that do not require access to systemic circulation for function (i.e., certain topical drugs). The bioavailability of these drugs is measured by different parameters discussed elsewhere.
Similar to In vitro Performance evaluation methods of Tablets (20)
Essential Trace elements and Iron.pptxKabin Maleku
Essential Trace elements
Definition of transition elements; Iron & haematenics; Functions of iron in the body, Causes of deficiency of iron. Focus on Compounds: Ferrous Fumarate; Ferrous Gluconate and Ferrous sulphate) Mineral Supplements (Cu, Zn, Cr, Mn, Sb, S, I).- Introduction, Role and deficiency.
Radiopharmaceuticals are radioactive pharmaceutical agents used for diagnostic or therapeutic procedures. They consist of a carrier molecule and a radionuclide. Common isotopes used include iodine-131, technetium-99m, cobalt-57, cobalt-60, gold-198, and iodine-125. Radiopharmaceuticals allow non-invasive monitoring of biological processes through imaging techniques. They are produced in specialized facilities and handled with precautions due to their radioactivity, requiring shielding and controlled storage conditions. Clinical applications include diagnosis of thyroid function and cancer treatment through targeted radiation exposure.
The document discusses filtration and clarification processes. It defines filtration as separating solids from fluid using a porous medium, while clarification refers to separating solids present at low concentrations (below 1.0% w/v) from liquid. The mechanisms of filtration include straining, impingement, entanglement, and attractive forces. Factors that influence filtration rates include properties of the liquid, solids, filter medium, temperature, and operating pressure. Common filter media include rigid media, flexible media, and filter aids. Filtration finds applications in pharmaceutical, chemical, and wastewater treatment industries.
The document discusses the handling of gases in the pharmaceutical industry. It describes the properties of gases including their diffusion, compressibility, and temperature/pressure dependence. It discusses the risks of gases and regulations for handling, storing, and transporting gas cylinders safely. The document outlines different types of gases used in the industry like nitrogen, oxygen, acetylene and their properties. It also discusses equipment for controlling gases including cylinders, regulators, valves, traps, piping and compressors. The principles and best practices for safely operating this equipment are provided.
This document discusses principles and methods for handling solids in pharmaceutical engineering. It begins by describing different types of solids like powders, granules, and how their properties like cohesiveness, moisture content, and particle size affect flow. It then discusses various methods for handling solids including different types of conveyors, bins, vacuum systems. Specific conveyor types covered are belt, screw, bucket, and pneumatic conveyors. Factors affecting powder flow like shape, moisture and methods to improve flow like granulation, vibration are also summarized.
Danphe is a highly innovative company which is committed for your health and well being. We bring our expertise in healthcare and technology to provide excellent care for you and your family. Our team has specialists from all around the world, mostly from Nepal and the United States of America. Our goal is to make a safe and high quality healthcare readily accessible to our patients at a reasonable cost.
www.danphecare.com
Multiparticulate dosage forms are pharmaceutical formulations in which the active substance is present as a number of small independent subunits. These sub units are compressed to form MUPS tablets
Introduction to CR/SR preparations, concept of controlled release formulation, challenges of CR drug delivery system, advantages and disadvantages, Factors influencing the design and performance of CR products (physiochemical properties: molecular size and diffusivity, aqueous solubility, ionization constant, partition coefficient, stability, pharmacokinetic and pharmacodynamic considerations: release rate and dose, Biological factors: Absorption, distribution, metabolism and elimination half life, therapeutic index, duration of action.
Kinetics of drug release from CRDS: Zero order, first order, Hixson-Crowell Release Model, Higuchi Release Model and Korsmeyer-Peppas Release Model
Oral controlled release systems: Dissolution controlled release (Matrix and encapsulated dissolution), diffusion controlled release (Reservoir and matrix system), dissolution and diffusion controlled release, Osmotically controlled release, pH independent formulations, Ion exchange resins.
Evaluation of CR formulations: Quality control methods( Identity, purity, strength, stability of the dosage form and drug in the dosage form, disintegration and dissolution, dosage form appearance, bioavailability of the drug from dosage form
Definition, role of gases in our body, focus on Oxygen, CO2 Inorganic anesthetics: Definition, Nitrous oxide Respiratory Stimulant: Definition, Ammonia solution, spirit of ammonia
Phr. Kabin Maleku
This document discusses dental products used to promote oral health, including dentifrices, anti-caries agents, and desensitizing agents. It describes dental plaque as a sticky biofilm that forms on teeth and contributes to dental caries. Fluoride is discussed as an effective anti-caries agent when applied topically or through public water supplies in low concentrations. Sodium fluoride and stannous fluoride are mentioned as common topical fluoride agents. Side effects from fluoride overdosing like dental fluorosis are also summarized.
Introduction/ Concept of acid and base, Importance of acids and bases in Pharmacy, storage condition. Official acids: Phosphoric acid (Conc/dil), HCl (Conc/dil), Boric acid. Official Bases: NaOH, KOH, Ca (OH)2, dil. and strong NH3, Na2CO3, Acidosis and Alkalosis.
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
This document provides an overview of pulmonary drug delivery systems (PDDS). It begins with an introduction to the history and advantages of pulmonary delivery. It then describes the anatomy and physiology of the lungs, including the different regions and cell types. Next, it discusses the mechanisms of particle deposition in the airways, including impaction, sedimentation, diffusion, and interception. It also covers factors that can affect deposition. The document concludes by exploring applications of PDDS and evaluation methods.
“Pellets Technology: Special focus on Wruster Coating and Extruder
spheronization”
Basic introduction, various methods of pellets technology, Wruster process, equipments, various process parameters and equipment parameters, Extrusion-Spheronization, Equipments, process and equipment parameters
The document discusses the various roles of pharmacists in healthcare, including working in community pharmacies, hospitals, academia, research and development, herbal medicine, industrial pharmacy, and regulatory and government roles. Pharmacists are involved in all aspects of medication from cultivation and extraction of plants to clinical drug development, dispensing and counseling patients, and ensuring safe and effective use of drugs. The field of pharmacy covers a wide range of specializations and responsibilities in improving public health.
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.
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- 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
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share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
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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
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3. Factors affecting dissolution rate
1. Disintegration is the important first step to drug dissolution in a tablet.
2. Particle size of drug substance.
3. Solubility and hydrophobicity of the drug; type and amount of disintegrant, diluent,
binder, lubricant, glidant and the coating type and thickness.
4. Solubility and dissolution also influenced by pH of the media, media composition,
change in the crystalinity of drug, temperature, paddle speed.
5. Manufacturing method (compactness of the granulation and compression force
used in tableting)
9. Media used in dissolution test:
- Purified water.
- Simulated gastric fluid.
- Simulated intestinal fluid.
- Solvents mixture may be used if the drug solubility is very low.
Dissolution test is performed in-process and on the final product.
10. Bioavailability studies and bioavailability testing protocol and
procedures
Bioavailability - Bioequivalence
11. Bioavailability
Bioavailability is a pharmacokinetic
term that describes the rate and
extent to which the active drug
ingredient is absorbed from a drug
product and becomes available at
the site of drug action.
Why?
Pharmacologic response is
generally related to the
concentration of drug at the
receptor site
Quantity of Drugs in
blood/Urine need to be
estimated
Assumption- Drug
concentration in blood is
equivalent to receptor site
concentration
12. Absolute Bioavailability
Tofraction of an
administered dose which
actually reaches the
systemic circulation
Denoted by F
Ranges from F = 0 (no
drug absorption) to F = 1
(complete drug
absorption).
13. Relative Bioavailability
Availability of a drug product
as compared to another
dosage form or product of the
same drug given in the same
dose.
The relative bioavailability of
product A compared to
product B, both products
containing the same dose of
the same drug, is obtained by
comparing their respective
14. Relative Bioavailability
When the bioavailability of
a generic product is
considered, it is usually the
relative bioavailability that
is referred to. A more
general form of the
equation results from
considering the possibility
of different doses:
16. Factors affecting Bioavaliability
disintegration of the drug product
dissolution of the drug in the fluids at the
absorption site
transfer of drug molecule across the
membrane lining the gastrointestinal tract into
the systemic circulation.
21. Methods of assessing bioavailability-
Predicting Clinical efficacy
In vivo:
Single dose
Normal/healthy adult
Clinical performance- Large test population
Need to be validated,
22. Methods of assessing bioavailability-
Predicting Clinical efficacy
Blood sampling
Parameters
1. AUC , The area under the plasma concentration-time curve, The
AUC is proportional to the total amount of drug reaching the
systemic circulation, and thus characterizes the extent of
absorption.
2. Cmax , The maximum drug concentration. The maximum
concentration of drug in the plasma is a function of both the rate
and extent of absorption. Cmax will increase with an increase in
the dose, as well as with an increase in the absorption rate.
3. Tmax , The time at which the Cmax occurs. The Tmax reflects the
rate of drug absorption, and decreases as the absorption rate
increases.
23. Methods of assessing bioavailability-
Predicting Clinical efficacy
Urinary Excretion Data
-determination of the total quantity of drug excreted in the urine as a function
of time
- urinary excretion of the unchanged drug is directly proportional to the
plasma concentration of total drug.
- Consider the following example: two products, A and B, each containing
100 mg of the same drug are administered orally. A total of 80 mg of drug is
recovered in the urine from Product A, but only 40 mg is recovered from
Product B. This indicates that twice as much drug was absorbed from
Product A as from Product B. (The fact that neither product resulted in
excretion of the entire dose might be due to the existence of other routes of
elimination, e.g. metabolism).
24. Methods of assessing bioavailability-
Predicting Clinical efficacy
Urinary Excretion Data
1. the fraction of drug entering the bloodstream
and being excreted intact by the kidneys
must remain constant.
2. collection of the urine has to continue until all
the drug has been completely excreted (five
times the half-life ).
25. Parameters for Urinary Excretion
1. Maximum urinary excretion
rate
2. Time for Maximum excretion
rate
3. Cumulative amount of Drug
excreted
26. The assessment o bioavailability by urinary
excretion is based on the assumption that the
appearance of the drug and/ or its metabolites in
the urine is a function of the rate and extent o
absorption. This assumption is only valid when a
drug and/ or its metabolites are extensively
excreted in the urine, and where the rate of
urinary excretion is proportional to the
concentration o the intact drug in the blood
plasma.
28. This proportionality does not hold
if:
the drug and/ or its metabolites are excreted
by an active transport process into the distal
kidney tubule
the intact drug and/ or its metabolites are
weakly acidic or weakly basic (i.e. their rate of
excretion is dependent on urine pH)
the excretion rate depends on the rate o urine
flow.
29. Interpretation: Plasma concentration-time curves for three different
formulations of the same drug administered in equal single doses by the same
extravascular route.
31. Biopharmaceutics Classification
System
Class I – high solubility/ high permeability
Class II – low solubility/ high permeability
Class III – high solubility/ low permeability
Class IV – low solubility/ low permeability.