The document discusses the Biopharmaceutics Classification System (BCS), which is a framework developed by the FDA to classify drugs based on their aqueous solubility and intestinal permeability. The BCS aims to improve drug development and review processes by identifying when clinical bioequivalence tests are not necessary. It classifies drugs as Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability) or Class IV (low solubility, low permeability) based on their solubility and permeability parameters. The classification can help determine if in vitro dissolution tests alone can demonstrate bioequivalence or if in vivo testing is still required.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics from simple in vitro tests and provide a scientific framework for biowaiver considerations. It categorizes drugs into four classes based on their solubility and permeability properties, with Class I drugs being the most suitable for oral administration due to their high solubility and permeability. The document outlines the classification system and its applications in drug development and regulation.
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS includes four classes based on whether a drug is highly soluble/permeable, poorly soluble/highly permeable, highly soluble/poorly permeable, or poorly soluble/permeable. The classification can help predict a drug's pharmacokinetics, guide product development and biowaivers, and support regulatory decisions regarding bioequivalence. Key factors like solubility, permeability, and dissolution rate are defined. Examples of drug classes are provided.
The document discusses the Biopharmaceutics Classification System (BCS), which classifies drugs based on their aqueous solubility and intestinal permeability. It defines the four BCS classes - Class I drugs have high solubility and high permeability, Class II have low solubility and high permeability, Class III have high solubility and low permeability, and Class IV have low solubility and low permeability. Factors that affect BCS classification include a drug's solubility, permeability, and dissolution rate. The BCS aims to predict a drug's in vivo performance based on solubility and permeability measurements in order to guide bioequivalence assessments and product development.
The Biopharmaceutical Classification System (BCS) was developed in 1995 to classify drugs based on their aqueous solubility and intestinal permeability. The BCS classifies drugs into four classes based on being high or low solubility and permeability. Class I drugs are highly soluble and permeable, while Class IV drugs are poorly soluble and permeable. The BCS aims to predict drug performance using solubility and permeability measurements and to determine if in vivo bioequivalence testing is necessary based on in vitro dissolution tests.
Biopharmaceutical classification system & drug delivery system associated wit...PratikShinde120
Biopharmaceutical classification system & drug delivery system based on BCS.
By Pratik shinde, Mpharm, University department of pharmaceutical sciences, Nagpur
The document discusses the Biopharmaceutics Classification System (BCS), which is a framework developed by the FDA to classify drugs based on their aqueous solubility and intestinal permeability. The BCS aims to improve drug development and review processes by identifying when clinical bioequivalence tests are not necessary. It classifies drugs as Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability) or Class IV (low solubility, low permeability) based on their solubility and permeability parameters. The classification can help determine if in vitro dissolution tests alone can demonstrate bioequivalence or if in vivo testing is still required.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics from simple in vitro tests and provide a scientific framework for biowaiver considerations. It categorizes drugs into four classes based on their solubility and permeability properties, with Class I drugs being the most suitable for oral administration due to their high solubility and permeability. The document outlines the classification system and its applications in drug development and regulation.
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS includes four classes based on whether a drug is highly soluble/permeable, poorly soluble/highly permeable, highly soluble/poorly permeable, or poorly soluble/permeable. The classification can help predict a drug's pharmacokinetics, guide product development and biowaivers, and support regulatory decisions regarding bioequivalence. Key factors like solubility, permeability, and dissolution rate are defined. Examples of drug classes are provided.
The document discusses the Biopharmaceutics Classification System (BCS), which classifies drugs based on their aqueous solubility and intestinal permeability. It defines the four BCS classes - Class I drugs have high solubility and high permeability, Class II have low solubility and high permeability, Class III have high solubility and low permeability, and Class IV have low solubility and low permeability. Factors that affect BCS classification include a drug's solubility, permeability, and dissolution rate. The BCS aims to predict a drug's in vivo performance based on solubility and permeability measurements in order to guide bioequivalence assessments and product development.
The Biopharmaceutical Classification System (BCS) was developed in 1995 to classify drugs based on their aqueous solubility and intestinal permeability. The BCS classifies drugs into four classes based on being high or low solubility and permeability. Class I drugs are highly soluble and permeable, while Class IV drugs are poorly soluble and permeable. The BCS aims to predict drug performance using solubility and permeability measurements and to determine if in vivo bioequivalence testing is necessary based on in vitro dissolution tests.
Biopharmaceutical classification system & drug delivery system associated wit...PratikShinde120
Biopharmaceutical classification system & drug delivery system based on BCS.
By Pratik shinde, Mpharm, University department of pharmaceutical sciences, Nagpur
Biopharmaceutical Classification system. A major system to classify the medicines based on its permeability and solubility. Detail explanation on the same. Specifically for the regulatory requirements. Work as material for MPharm RA students under PCI syllabus.
Pharmacy presentation about BCS classification its criteria.Biowaiever and its conditions .permeability studies in vivo,invitro,in situ.mpharmacy b pharmacy pharmaceutics
The document provides an overview of the Biopharmaceutics Classification System (BCS). The BCS classifies drugs into four classes based on their aqueous solubility and permeability characteristics. Class I drugs are highly soluble and permeable. Class II drugs are highly permeable but poorly soluble. Class III drugs are highly soluble but poorly permeable. Class IV drugs exhibit low solubility and permeability. The BCS is used to guide drug product development and determine if in vivo bioequivalence studies can be waived based on in vitro dissolution testing.
Biopharmaceutical Classification System (BCS)Suraj Khali
The Biopharmaceutical Classification System (BCS) classifies drug compounds based on their solubility and permeability properties. The BCS can be used to predict in vivo pharmacokinetics and determine when a waiver for bioavailability and bioequivalence studies may be requested. BCS Class I drugs that are highly soluble and permeable are most suitable for oral administration as they are rapidly dissolved and absorbed. The BCS aids in drug development by using solubility and permeability measurements to predict in vivo drug performance and guide biowaiver considerations.
biopharmaceuticals classification system and biowaiverRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses biowaiver consideration based on the Biopharmaceutics Classification System (BCS). It provides an introduction to biowaivers and outlines the four classes in the BCS. The key requirements for a BCS-based biowaiver are described, including demonstrating high solubility, high permeability, and rapid dissolution of the drug product. The types of data needed to support a biowaiver request are summarized. Additional factors like excipients, prodrugs, and exceptions are also covered.
Biopharmaceutical system , methods of permeability , generic biologics, gener...Siddhapura Pratik
Biopharmaceutical classification system, methods of permeability, generic biologics ( biosimilar drug product), clinical significance of bioequivalence studies , special concerns in bioavailability and bioequivalence studies , Generic substitution
BCS Guideline for solubility and Dissolution.pptxImdad H. Mukeri
Briefly explanation of The Biopharmaceutics Classification System (BCS) of drug substance
and its solubility in the pH range of 1–7.5, absorption or intestinal membrane permeability
Biopharmaceutics classification system class 1Aloysiatreslyn
Biopharmaceutics classification system class
defination,bcs,class1 drugs,physiochemical parameters,advantages,disadvantages,list of drugs,formulaton consideration,solubility,permability,disssolution etc .The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. This system restricts the prediction using the parameters solubility and intestinal permeability.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS categorizes drugs into four classes and can be used to guide formulation strategies. It provides a framework for biowaivers where in vivo bioequivalence studies are not required for highly soluble, highly permeable Class I drugs and highly soluble Class III drugs, if the drug products dissolve rapidly. The BCS aims to improve drug development efficiency by identifying bioequivalence tests that can be waived.
The document provides an overview of the Biopharmaceutics Classification System (BCS). The BCS is a scientific framework used to classify drug substances based on their aqueous solubility and intestinal permeability. It includes four classes based on whether a drug is highly soluble/permeable, low soluble/high permeable, etc. The BCS is used to determine a drug's bioavailability and guide formulation approaches. It can help obtain a biowaiver for in vivo bioequivalence studies if a drug meets certain solubility and permeability criteria. While useful, the BCS has some limitations in predicting drug behavior due to challenges in determining permeability.
The document provides an overview of the Biopharmaceutics Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's absorption based on these characteristics. It defines four classes of drugs. Class 1 drugs are highly soluble and permeable, while Class 4 drugs are poorly soluble and permeable. The BCS guidance provided by the FDA can help determine if in vivo bioequivalence studies are needed for new drug products. It provides a framework for biowaivers and for developing formulations to improve solubility or permeability depending on a drug's class.
The document summarizes the Biopharmaceutics Classification System (BCS), which classifies drugs based on their aqueous solubility and intestinal permeability. The BCS includes four classes of drugs. Class 1 drugs are highly soluble and highly permeable. Class 2 drugs are poorly soluble but highly permeable. Class 3 drugs are highly soluble but poorly permeable. Class 4 drugs are poorly soluble and poorly permeable. The BCS aims to provide a scientific framework for predicting a drug's absorption and bioavailability based on its solubility and permeability characteristics. It can help guide drug development and determine if in vivo bioequivalence studies are necessary for approval of generic drugs.
This document discusses dissolution testing, which is used to evaluate how quickly an active pharmaceutical ingredient is released from its solid dosage form after administration. Key points include:
- Dissolution is the process by which a solid enters solution and is controlled by the affinity between the solid and solvent.
- Dissolution testing seeks to relate in vitro dissolution to in vivo drug absorption and bioavailability.
- The Biopharmaceutics Classification System categorizes drugs based on their solubility and permeability properties to determine the rate-limiting step of absorption.
- Procedures for dissolution testing must account for factors like pH, surfactants, and apparatus to mimic conditions in the gastrointestinal tract.
- Diss
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS has four classes based on whether a drug is highly soluble/permeable or low soluble/permeable. It provides a framework to determine if in vitro dissolution tests can replace bioequivalence studies for certain drugs. The BCS considers factors like dose/solubility ratios, dissolution rates, and permeability to classify drugs and determine regulatory applications like biowaivers for bioequivalence studies.
This document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics based on these factors. It describes the four classes of drugs based on whether they are highly soluble and permeable, soluble but poorly permeable, etc. The BCS can be used to guide drug development and biowaivers and determine appropriate drug delivery technologies and formulations.
This document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics based on these factors. It defines four classes of drugs based on whether they are highly soluble and permeable, soluble but poorly permeable, etc. The BCS can be used to guide drug development and biowaivers, and help determine appropriate drug delivery technologies and formulations.
Dr. Tan's Balance Method.pdf (From Academy of Oriental Medicine at Austin)GeorgeKieling1
Home
Organization
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
About AOMA: The Academy of Oriental Medicine at Austin offers a masters-level graduate program in acupuncture and Oriental medicine, preparing its students for careers as skilled, professional practitioners. AOMA is known for its internationally recognized faculty, award-winning student clinical internship program, and herbal medicine program. Since its founding in 1993, AOMA has grown rapidly in size and reputation, drawing students from around the nation and faculty from around the world. AOMA also conducts more than 20,000 patient visits annually in its student and professional clinics. AOMA collaborates with Western healthcare institutions including the Seton Family of Hospitals, and gives back to the community through partnerships with nonprofit organizations and by providing free and reduced price treatments to people who cannot afford them. The Academy of Oriental Medicine at Austin is located at 2700 West Anderson Lane. AOMA also serves patients and retail customers at its south Austin location, 4701 West Gate Blvd. For more information see www.aoma.edu or call 512-492-303434.
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Biopharmaceutical Classification system. A major system to classify the medicines based on its permeability and solubility. Detail explanation on the same. Specifically for the regulatory requirements. Work as material for MPharm RA students under PCI syllabus.
Pharmacy presentation about BCS classification its criteria.Biowaiever and its conditions .permeability studies in vivo,invitro,in situ.mpharmacy b pharmacy pharmaceutics
The document provides an overview of the Biopharmaceutics Classification System (BCS). The BCS classifies drugs into four classes based on their aqueous solubility and permeability characteristics. Class I drugs are highly soluble and permeable. Class II drugs are highly permeable but poorly soluble. Class III drugs are highly soluble but poorly permeable. Class IV drugs exhibit low solubility and permeability. The BCS is used to guide drug product development and determine if in vivo bioequivalence studies can be waived based on in vitro dissolution testing.
Biopharmaceutical Classification System (BCS)Suraj Khali
The Biopharmaceutical Classification System (BCS) classifies drug compounds based on their solubility and permeability properties. The BCS can be used to predict in vivo pharmacokinetics and determine when a waiver for bioavailability and bioequivalence studies may be requested. BCS Class I drugs that are highly soluble and permeable are most suitable for oral administration as they are rapidly dissolved and absorbed. The BCS aids in drug development by using solubility and permeability measurements to predict in vivo drug performance and guide biowaiver considerations.
biopharmaceuticals classification system and biowaiverRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses biowaiver consideration based on the Biopharmaceutics Classification System (BCS). It provides an introduction to biowaivers and outlines the four classes in the BCS. The key requirements for a BCS-based biowaiver are described, including demonstrating high solubility, high permeability, and rapid dissolution of the drug product. The types of data needed to support a biowaiver request are summarized. Additional factors like excipients, prodrugs, and exceptions are also covered.
Biopharmaceutical system , methods of permeability , generic biologics, gener...Siddhapura Pratik
Biopharmaceutical classification system, methods of permeability, generic biologics ( biosimilar drug product), clinical significance of bioequivalence studies , special concerns in bioavailability and bioequivalence studies , Generic substitution
BCS Guideline for solubility and Dissolution.pptxImdad H. Mukeri
Briefly explanation of The Biopharmaceutics Classification System (BCS) of drug substance
and its solubility in the pH range of 1–7.5, absorption or intestinal membrane permeability
Biopharmaceutics classification system class 1Aloysiatreslyn
Biopharmaceutics classification system class
defination,bcs,class1 drugs,physiochemical parameters,advantages,disadvantages,list of drugs,formulaton consideration,solubility,permability,disssolution etc .The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. This system restricts the prediction using the parameters solubility and intestinal permeability.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS categorizes drugs into four classes and can be used to guide formulation strategies. It provides a framework for biowaivers where in vivo bioequivalence studies are not required for highly soluble, highly permeable Class I drugs and highly soluble Class III drugs, if the drug products dissolve rapidly. The BCS aims to improve drug development efficiency by identifying bioequivalence tests that can be waived.
The document provides an overview of the Biopharmaceutics Classification System (BCS). The BCS is a scientific framework used to classify drug substances based on their aqueous solubility and intestinal permeability. It includes four classes based on whether a drug is highly soluble/permeable, low soluble/high permeable, etc. The BCS is used to determine a drug's bioavailability and guide formulation approaches. It can help obtain a biowaiver for in vivo bioequivalence studies if a drug meets certain solubility and permeability criteria. While useful, the BCS has some limitations in predicting drug behavior due to challenges in determining permeability.
The document provides an overview of the Biopharmaceutics Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's absorption based on these characteristics. It defines four classes of drugs. Class 1 drugs are highly soluble and permeable, while Class 4 drugs are poorly soluble and permeable. The BCS guidance provided by the FDA can help determine if in vivo bioequivalence studies are needed for new drug products. It provides a framework for biowaivers and for developing formulations to improve solubility or permeability depending on a drug's class.
The document summarizes the Biopharmaceutics Classification System (BCS), which classifies drugs based on their aqueous solubility and intestinal permeability. The BCS includes four classes of drugs. Class 1 drugs are highly soluble and highly permeable. Class 2 drugs are poorly soluble but highly permeable. Class 3 drugs are highly soluble but poorly permeable. Class 4 drugs are poorly soluble and poorly permeable. The BCS aims to provide a scientific framework for predicting a drug's absorption and bioavailability based on its solubility and permeability characteristics. It can help guide drug development and determine if in vivo bioequivalence studies are necessary for approval of generic drugs.
This document discusses dissolution testing, which is used to evaluate how quickly an active pharmaceutical ingredient is released from its solid dosage form after administration. Key points include:
- Dissolution is the process by which a solid enters solution and is controlled by the affinity between the solid and solvent.
- Dissolution testing seeks to relate in vitro dissolution to in vivo drug absorption and bioavailability.
- The Biopharmaceutics Classification System categorizes drugs based on their solubility and permeability properties to determine the rate-limiting step of absorption.
- Procedures for dissolution testing must account for factors like pH, surfactants, and apparatus to mimic conditions in the gastrointestinal tract.
- Diss
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS has four classes based on whether a drug is highly soluble/permeable or low soluble/permeable. It provides a framework to determine if in vitro dissolution tests can replace bioequivalence studies for certain drugs. The BCS considers factors like dose/solubility ratios, dissolution rates, and permeability to classify drugs and determine regulatory applications like biowaivers for bioequivalence studies.
This document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics based on these factors. It describes the four classes of drugs based on whether they are highly soluble and permeable, soluble but poorly permeable, etc. The BCS can be used to guide drug development and biowaivers and determine appropriate drug delivery technologies and formulations.
This document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS aims to predict a drug's pharmacokinetics based on these factors. It defines four classes of drugs based on whether they are highly soluble and permeable, soluble but poorly permeable, etc. The BCS can be used to guide drug development and biowaivers, and help determine appropriate drug delivery technologies and formulations.
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Dr. Tan's Balance Method.pdf (From Academy of Oriental Medicine at Austin)GeorgeKieling1
Home
Organization
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
About AOMA: The Academy of Oriental Medicine at Austin offers a masters-level graduate program in acupuncture and Oriental medicine, preparing its students for careers as skilled, professional practitioners. AOMA is known for its internationally recognized faculty, award-winning student clinical internship program, and herbal medicine program. Since its founding in 1993, AOMA has grown rapidly in size and reputation, drawing students from around the nation and faculty from around the world. AOMA also conducts more than 20,000 patient visits annually in its student and professional clinics. AOMA collaborates with Western healthcare institutions including the Seton Family of Hospitals, and gives back to the community through partnerships with nonprofit organizations and by providing free and reduced price treatments to people who cannot afford them. The Academy of Oriental Medicine at Austin is located at 2700 West Anderson Lane. AOMA also serves patients and retail customers at its south Austin location, 4701 West Gate Blvd. For more information see www.aoma.edu or call 512-492-303434.
Congestive Heart failure is caused by low cardiac output and high sympathetic discharge. Diuretics reduce preload, ACE inhibitors lower afterload, beta blockers reduce sympathetic activity, and digitalis has inotropic effects. Newer medications target vasodilation and myosin activation to improve heart efficiency while lowering energy requirements. Combination therapy, following an assessment of cardiac function and volume status, is the most effective strategy to heart failure care.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
Discover the benefits of homeopathic medicine for irregular periods with our guide on 5 common remedies. Learn how these natural treatments can help regulate menstrual cycles and improve overall menstrual health.
Visit Us: https://drdeepikashomeopathy.com/service/irregular-periods-treatment/
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
2. INTRODUCTION
• The biopharmaceutics classification system is guidance for
Predicting the intestinal drug absorption provided by the U.S.
Food and Drug Administration. The fundamental basis for the
BCs was established by Dr. Gordon Amidon.
DEFINITION
• The Biopharmaceutical Classification System is a scientific
framework for classifying a drug substance based on its
aqueous solubility & intestinal permeability & dissolution rate.
3. OBJECTIVE OF THE BCS
• To improve the efficiency of the drug development and review
process by recommending a strategy for identifying expendable
clinical bioequivalence test.
• To recommend a class of immediate-release (IR) solid oral
dosage forms for which bioequivalence may be assessed based
on in vitro dissolution tests.
• To recommend methods for classification according to dosage
form dissolution along with the solubility– permeability
characteristics of the drug product.
4. CLASSIFICATIAON
• According to the BCS, drug substances are classified as follows:
A. CLASS I
1.
2.
3.
High Permeability and high Solubility.
These are well absorbed and their absorption rate is usually higher
than excretion.
Example - Metoprolol.
B. CLASS II
1.
2.
3.
High Permeability and Low Solubility.
Bioavailability is limited by their solvation rate.
Example- Glibenclmide.
5. B. CLASS III
1.
2.
3.
Low Permeability and High Solublity.
The absorption is limited by the permeation rate but drug is solvated very
fast.
Example- Cimetidine.
C. CLASS IV
1.
2.
3.
Low Permeability
And High Solubility.
Poor bioavailability and
Not well absorbed over the intestinal mucosa.
Example- Hydrochlorothiazide.
6. PARAMETERS OF DRUGS CLASSIFIED IN BCS
The drugs are classified inn BCS on the basis of following parameters:
1. SOLUBILITY
• The Maximum Amount of solute dissolved in a given solvent under
standard conditions of temperature, pressure and pH.
• Solubility is the ability of the drug to be solution after dissolution.
• The higher single unit dose is completely soluble in 250 ml at pH 1-
6.8 ( 37˚C ).
7. 2. PERMEABILITY
• Permeability of the drug to pass the biological
membrane which is the lipophilic.
• Permeability is indirectly based on the extent of
absorption of a drug substance.
• Drug substance is considered to be highly permeable,
when the extent of absorption in human determined to
be 90% or more of administered drug or compare to in
vivo reference dose.
8. DISSOLUTION
• A drug product is considered to be RAPIDLY DISSOLVING
when > 85% of the labeled amount of drug substance dissolves
within 30 minutes using USP dissolution apparatus I or II in a
volume of 900 ml or less in the following media:
1.0.1 N HCl or simulated gastric fluid (pH 1.2) without enzyme.
2. pH 4.5 buffer & pH 6.8 buffer.
3. Simulated intestinal fluid without enzyme.
9. APPLICATIONS OF BIOPHARMACEUTICS
• To predict in vivo performance of drug product using solubility
and permeability measurements.
• Aid in earliest stages of drug discovery research.
• For research scientist to decide upon which drug delivery
technology to follow or develop.
• Also for the regulation of bioequivalence of the drug product
during scale up and post approval.
10. CONCLUSION
• Biopharmaceutical classification system aims to provide
regulatory tools for replacing certain bio-equivalence studies by
accurate in vivo dissolution tests.
• The in vivo pharmacokinetics of drug depends largely on the
solubility and permeability.
• Many laboratories are engaged to find better means to estimates
in vivo behavior of the drug after oral administration by using
simple in vitro dissolution tests