INSTITUTIONAL REVIEW BOARD.pptx
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This document discusses Institutional Review Boards/Independent Ethics Committees (IRB/IEC) and their role and responsibilities. It explains that IRB/IECs serve as independent bodies that review clinical trial protocols to evaluate scientific and ethical aspects and protect participant safety and rights. The document outlines the background, composition, responsibilities and procedures of IRB/IECs, including reviewing proposed trials, providing continuing oversight, and maintaining records for regulatory authorities. IRB/IEC membership includes experts from medical, scientific, non-scientific, and layperson backgrounds.
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This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
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An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
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Niosome An Non-Ionic Surfactant Vesicles.pptx
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosomes (Formulation and evaluation).pptx
Niosomes are a novel drug delivery system that encapsulates the medication in a vesicular system made up of non ionic surfactants.
The vesicle is made up of a bilayer of non-ionic surfactants, thus the name niosomes.
Niosomes are extremely small and microscopic (on a nanometric scale).
Despite having a similar structure to liposomes, they have several advantages over them.
Niosomes are biocompatible, nonimmunogenic, and biodegradable in nature and exhibit flexibility in their structured characterization
Based on the vesicle size, niosomes can be divided into three groups.
Small unilamellar vesicles (SUV, size=0.025-0.05 μm),
Multilamellar vesicles (MLV, size=>0.05 μm), and
Large unilamellar vesicles (LUV, size=>0.10 μm).
In the formulation of niosomes, the selection of surfactants is based on hydrophilic-lipophilic balance (HLB) value. HLB values between 4 and 8 recommended for the facile formation of niosomes and surfactants with an HLB value of more than 8 are required to optimize cholesterol concentration.
However, it has been widely observed that HLB value between 4 and 8 is highly recommended for better encapsulation efficiency, of niosomes. For example, long stearyl and short lauryl chain length increase and decrease the entrapment efficiency of niosomes, respectively.
Long hydrophilic chains result in increased encapsulation of hydrophilic drugs, and long hydrophobic chains result in improved encapsulation of lipophilic drugs.
Long Hydrophilic Chains and Increased Encapsulation of Hydrophilic Drugs:
Surfactants with longer hydrophilic chains create larger aqueous compartments within the niosome bilayer. This provides more space for water-soluble drugs to reside, leading to higher encapsulation efficiency.
Example: Span 60 (HLB 4.7) has a longer hydrophilic chain compared to Span 20 (HLB 8.6). Studies have shown that using Span 60 in niosomes resulted in significantly higher encapsulation efficiency of the hydrophilic drug gentamicin, compared to formulations using Span 20.
Long Hydrophobic Chains and Improved Encapsulation of Lipophilic Drugs:
Long hydrophobic chains increase the affinity of the niosome bilayer for lipid-soluble drugs. These drugs can partition and entrap themselves within the bilayer structure, leading to improved encapsulation.
Example: Tween 80 (HLB 15) has a longer hydrophobic chain compared to Tween 20 (HLB 16.7). Niosomes prepared with Tween 80 demonstrated superior encapsulation of the lipophilic drug curcumin compared to those made with Tween 20.
Pegylation is a process where polyethylene glycol (PEG), a biocompatible and hydrophilic polymer, is attached to the surface of niosomes. This modification offers several advantages for drug delivery:
Benefits of Pegylation:
Increased Stability: PEG creates a steric barrier, preventing proteins and other molecules in the blood from adhering to the niosome surface. This reduces aggregation and opsonization (recognition by immune cells).
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); Advanceme...
Non-ionic surfactant vesicles, commonly referred to as niosomes, have garnered significant attention within the pharmaceutical industry due to their remarkable capacity to encapsulate both hydrophilic and hydrophobic drugs. Recent studies have demonstrated the potential of these vesicles to enhance the bioavailability of drugs, making them a promising strategy for delivering various therapeutic agents such as gene materials, protein therapeutics, and chemical pharmaceuticals. This approach offers minimal toxicity and desirable targeting effectiveness. Niosomes are substantially more stable during the preparation and storage procedure than liposomes. The desired pharmacokinetics property can be attained through the optimization of constituents or surface modifications. This novel method of distribution is also facile to establish and expand, while maintaining cost-effective manufacturing expenses. This review article elucidates the fundamentals of niosomes as non-ionic surfactant vesicles, including their structure and components, as well as various formulation methods. Additionally, the article explores the diverse applications of niosomal in the analgesics.
The Application of Response Surface Methodology (RSM) In the Computational Op...
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
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employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
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Determination of Partition coefficient of Known and Unknown drug.pdf
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
Pharmaceutical Suspension Dosage Form (PPT)
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.ppt
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination.pptx
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
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THE CURRENT STATUS IN MUCOSALDRUG DELIVERY SYSTEM (MDDS)AND FUTURE PROSPECTUS...
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Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
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ProductManagement-InventroyManagementandControls.pptx
This document discusses product management, material management, inventory management, and control in the pharmaceutical industry. It defines key terms like CGMP, material management, inventory classification, and inventory control techniques. The objectives of inventory management are to avoid stockouts and shortages while minimizing costs. Techniques like ABC analysis, VED analysis, EOQ, perpetual inventory, and buffer stock are described for effective inventory control. The roles and responsibilities of pharmacists in drug procurement are also outlined.
IMPORTSOFDRUGS.pptx
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
MicrospheresPreparationandEvaluations.pptx
Microspheres are small spherical particles, with diameter 1 µm to 1000 µm.
They are spherical free flowing particles consisting of proteins or synthetic polymers which are biodegradable in nature.
Protein and Peptide.pptx
PROTEINS: Proteins are the large organic compounds made of amino acids arranged in a linear chain and joined together by peptide bonds.
Protein > 50 amino acids
PEPTIDES: These are short polymers formed from the linking, in a defined order of amino acids.
Peptide < 50 amino acids
NanoTechnology3DEuropeanChemicalBulletin.pdf
Three-dimensional (3-D) printing is elevating various growth in production viewpoint both at nanoscale and macro-scales. 3-D printing is being scouted for numerous bio-pharmaceutical administration and creation of nano-medicines employing supplementary production methods and shows assurance in capability in satisfying the demands for a patient-based customized approach. The previous outcome features the accessibility of novel natural bio-materials and finely designed polymeric substances, which can be created as unique 3-D printed nano-materials for numerous bio-pharmaceutical administrations as nano-medicines. Nano-medicine is described as the utilization of nanoscience in fabricating nano-materials for various pharmaceutical utilization, comprising identification, cure, scan, stopping, and management of diseases. Nano-medicine has also displayed a huge effect in the creation and evolve an accurate drug. In contrary the "one-size-fits-all" benchmark for the traditional drug is a personalized, structured, or accurate drug considering the variation in numerous characteristics, comprising genetics and pharmacokinetics of various victims, which have exhibited better outcomes over traditional cures. This article highlights the approaches advancements in the design and development of customized-made nano-medicine employing 3-D printing science.
TOTAL QUALITY MANAGEMENT, BUDGET & COST CONTROL.pptx
Definition: TQM has been defined as an integrated organization effort designed to improve quality at every level.
“ The process to produce a perfect product by a series of measures require an organized effort by the entire company to prevent or eliminate errors at every stage in production is called Total Quality Management (TQM).”
The Aim of TQM is “Prevention of defect rather than detection on defect.”
TQM is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of health care system and also protect waste of money for both government and individual customer.
IntroductiontoPharmacyPharmaceutics.pptx
The word pharmacy is derived from the Greek word “Pharmakon”, meaning medicine or drug. In other term, “Pharmacy may defined as the art and science of preparing (manufacturing) and dispensing of drugs prepared by the natural and synthetic sources and using for the treatment as well as prevention of diseases”. In general sense, it is the place where medicine or drugs are sold. Pharmacy is a health profession that links health science with chemical science and aims to ensure the safe and effective use of pharmaceutical drugs. It includes the collection, identification, synthesis, purification, isolation and quality control of medical substance or pharmaceutical products.
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Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
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Chapter 4
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Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
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INSTITUTIONAL REVIEW BOARD.pptx
- 1. INSTITUTIONAL REVIEW BOARD/INDEPEDENT ETHICS COMMITTEE (IRB/IEC) S U B M I T T E D B Y: P R A C H I PA N D E Y, R A H U L PA L REGULATORY AFFAIRS
- 2. CONTENT IRB/IEC 2 INTRODUCTION BACKGROUND COMPOSITION RESPONSIBILITIES OF IRB/IEC PROCEDURE OF IRB/IEC MAINTENANCE OF RECORD OF IRB/IEC
- 3. INTRODUCTION 3 IRB/IEC serves as an independent body that reviews, evaluate, approves and decides on the scientific and ethical aspects of the clinical trial protocol as well as the benefits and risks to the study participants. Main purpose of IRB/IEC is to protect the rights, safety and well being of the subjects who participate in a trial.
- 4. BACKGROUND • National research act passed by congress on July 12, 1974, mandated establishment of IRB/IEC. • Act provide national commission for protection of human subjects of biomedical and behavioral research and lead to publication of The Belmont Report in 1979. • The amended regulation on July 27, 1981. • Submission of NDA’S approval of IRB is necessary. 4
- 5. COMPOSITION IRB Consists of members, who • Collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trials. • Include at least five members, of which at least one members whose primary area of interest is nonscientific discipline and at least one member who is independent of the institutional/trial site. 5 IRB/IEC
- 6. IRB/IEC MEMBERSHIP Members of ICE: • Chair person. • 1-2 basic medical scientists. • 1-2 clinicians from various institutes. • One legal exert or retired judge. • One social scientist. • One philosopher/ethicist. • One lay person. • Member secretary. 6 IRB/IEC
- 7. RESPONSIBILITIES OF IRB/IEC The Committee has been designated to- • Approve • Monitor • Review biomedical and behavioral research, involving humans with the aim to protect the rights, safety and welfare of the research subjects. • Safeguard the rights, safety and well-being of all trial subjects. • Reviews a proposed clinical trial within a reasonable time and documents its view s in writing. • Conducts continuing review of each ongoing trails at least once per year. 7 PRESENTATION TITLE
- 8. PROCEDURE OF IRB/IEC • Determines its composition and authority under which it is established. • Schedules, notifies its members of, and conducts its meetings. • Conducts initial and continuing review of trials. • Specifies that no subjects should be admitted to atrial before the IRB/IEC issues its written approval/favorable opinion of the trail. • Specifies the information that the investigator should promptly report to the IRB/IEC (like deviations from the protocol, adverse drug reactions etc) 8 PRESENTATION TITLE
- 10. MAINTENANCE OF RECORD OF IRB/IEC • IRB/IEC retains all relevant records (e.g. written procedures, lists of occupations/affiliations of members, submitted document, minutes of meeting etc.) for period of at least 3 years after completion of the trial and makes them available upon request from the regulatory authorities. • IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide copies of its written procedures and membership lists. 1 0 PRESENTATION TITLE