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.
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Bioavailability & Bioequivalence Studies
https://youtube.com/vishalshelke99
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Sub :- Research Methodology
M.Phrmacy Semister 1
Savitribai Phule Pune University
Bioavailability:
Bioavailability is defined as a measure, of the rate and amount of drug, which reaches the systemic circulation unchanged following the administration of a dosage form.
Absolute bioavailability:
When systemic availability of a drug administered orally
is determined in comparison to its I.V. administration, denoted by F.
Relative bioavailability:
When systemic availability of a drug after oral administration is
Compared with that of oral standard of the same drug
( Solution or suspension ) and denoted by Fr.
Methods For Assesment Of Bioavailability Anindya Jana
Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Bioavailability studies are important in the Primary stages of development of a suitable dosage form for a new drug entity, determination of influence of excipients, patient related factors & possible interaction with other drugs on the efficiency of absorption, development of new formulations of the existing drugs, control of quality of a drug product during the early stages of marketing in order to determine the influence of processing factors, storage & stability on drug absorption
CHRONOPHARMACOKINETICS AND TIME DEPENDENT PHARMACOKINETICSN Anusha
Chronopharmacokinetic studies have been demonstrating that time of administration is a possible factor of variation in the kinetics of the drug.
It entails the study of temporal changes in drug absorption, distribution, metabolism and elimination.
It investigates the variation in drug plasma levels as a function of time of day and the mechanisms responsible for time dependant variations.
The term circadian coined by Franz Halberg, comes from Latin.
“Circa” means around &“diem” means day.
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Bioavailability & Bioequivalence Studies
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Research Methodology
M.Phrmacy Semister 1
Savitribai Phule Pune University
Bioavailability:
Bioavailability is defined as a measure, of the rate and amount of drug, which reaches the systemic circulation unchanged following the administration of a dosage form.
Absolute bioavailability:
When systemic availability of a drug administered orally
is determined in comparison to its I.V. administration, denoted by F.
Relative bioavailability:
When systemic availability of a drug after oral administration is
Compared with that of oral standard of the same drug
( Solution or suspension ) and denoted by Fr.
Methods For Assesment Of Bioavailability Anindya Jana
Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Bioavailability studies are important in the Primary stages of development of a suitable dosage form for a new drug entity, determination of influence of excipients, patient related factors & possible interaction with other drugs on the efficiency of absorption, development of new formulations of the existing drugs, control of quality of a drug product during the early stages of marketing in order to determine the influence of processing factors, storage & stability on drug absorption
CHRONOPHARMACOKINETICS AND TIME DEPENDENT PHARMACOKINETICSN Anusha
Chronopharmacokinetic studies have been demonstrating that time of administration is a possible factor of variation in the kinetics of the drug.
It entails the study of temporal changes in drug absorption, distribution, metabolism and elimination.
It investigates the variation in drug plasma levels as a function of time of day and the mechanisms responsible for time dependant variations.
The term circadian coined by Franz Halberg, comes from Latin.
“Circa” means around &“diem” means day.
Measurement of bioavailability and concept of equivalenceRavish Yadav
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1. Measurement of Bioavailability:
Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.
Pharmacokinetic and/or pharmacodynamic parameters as well as clinical observations and in-vitro studies may be used to determine drug bioavailability from a drug product.
1.1. Pharmacokinetic methods:
These are very widely used and based upon the assumption that the pharmacokinetic profile reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. The two major pharmacokinetic methods are:
The major pharmacokinetic methods are:
Plasma / blood level time profile.
o Time for peak plasma (blood) concentration (t max)
o Peak plasma drug concentration (Cmax)
o Area under the plasma drug concentration–time curve (AUC)
Urinary excretion studies.
o Cumulative amount of drug excreted in the urine (Du)
o Rate of drug excretion in the urine (dDu/dt)
o Time for maximum urinary excretion (t)
C. Other biological fluids
1.2. Pharmacodynamic methods:
IT involves direct measurement of drug effect on a (patho) physiological process as a function of time. Disadvantages of it may be high variability, difficult to measure, limited choices, less reliable, more subjective, drug response influenced by several physiological & environmental factors.
They involve determination of bioavailability from:
Acute pharmacological response.
Therapeutic response.
1.3. In-vitro dissolution studies
Closed compartment apparatus
Open compartment apparatus
Dialysis systems.
1.4. Clinical observations
Well-controlled clinical trials
Bioequivalence studies for various pharmaceutical drug formulations manufactured and released into the market is outlined in this presentation. The various studies used to establish bioequivalency with the original formulation is also mentioned.
Circular Dichroism Spectroscopy
Introduction
Amino Acid Structure & Polarity
Protein Structures
Polarization of Light
Circular Dichroism
Measurement of Circular Dichroism
Instrumentation For CD Spectropolarimeter
CD Spectrum
CD Spectra of Protein Secondary Structures
Other - CD Based Techniques
Conclusion
References
Microbial Assay of Antibiotics
STANDARD PREPARATION AND UNITS OF ACTIVITY
Preparation of media
Buffer solutions
Standard solution
Sample solution
Test organisms
Preparation of inoculum Method -1
Method 2
Method 3
Method 4
Determination of Inoculum
Apparatus
Assay design
Assay method
cylinder plate method
One level assay with standard curve
Estimation of potency
Turbidimetric method
Health & Dimensions of Health
Health
Dimensions of Health
WHO
OPERATIONAL DEFINITION
Broad Sense
Narrow sense
PHYSICAL DIMENSION
MENTAL DIMENSION
Features of mentally healthy person
SOCIAL DIMENSION
SPIRITUAL DIMENSION
Socio Cultural Factors Related to Health and Disease Aditya Sharma
Socio Cultural Factors Related to Health and Disease
PPT
Heredity
Environment
Lifestyle
Socio-economic conditions
Health services
Education
Income
Housing
Residual solvents
USP <467>
ICH Q3C
Classification of Residual Solvents by Risk Assessment
Options for Determining Levels of Class 2 Residual Solvents
Methods For Establishing Exposure Limits
Analytical Procedures
Taxol and Derivatives in Therapy
Introduction
Mechanism of Action
Structure-Activity Relationship of Taxol
Side Effects of Taxol
Paclitaxel/Taxol In Cancer Therapy
Docetaxel
Drug Interactions of Docetaxel
Taxanes: Complicating Factors
References
National Programme for Prevention and Control of Deafness (NPPCD)Aditya Sharma
National Programme for Prevention and Control of Deafness (NPPCD)
Introduction
Programme Execution & Expansion
Objectives of the Programme
Components of the Programme
Strategies
Expected Benefits of the Programme
NMR Instrumentation
ppt
Magnet
Permanent and conventional electromagnets
The Magnetic Field Sweep
Sweep Generator
frequency sweep method
field sweep method
The Sample Holder
The Sample Probe
Radio Frequency Generator
Oscillator
Radio Frequency Receiver
Amplifier
The Signal Detector and Recording System
NMR Instrumentation
ppt
Magnet
Permanent and conventional electromagnets
The Magnetic Field Sweep
Sweep Generator
frequency sweep method
field sweep method
The Sample Holder
The Sample Probe
Radio Frequency Generator
Oscillator
Radio Frequency Receiver
Amplifier
The Signal Detector and Recording System
PRINCIPLES of FT-NMR & 13C NMR
Fourier Transform
FOURIER TRANSFORM NMR SPECTROSCOPY
THEORY OF FT-NMR
13C NMR SPECTROSCOPY
Principle
Why C13-NMR is required though we have H1-NMR?
CHARACTERISTIC FEATURES OF 13 C NMR
Chemical Shifts
NUCLEAR OVERHAUSER ENHANCEMENT
Short-Comings of 13C-NMR Spectra
Stability and Shelf Life
Introduction
Stability Testing Methods:
Real Time Stability Testing
Accelerated Stability Testing
Retained Sample Stability Testing
Cyclic Temperature Stress Testing
Expiration Date/Shelf Life
Estimation of Shelf Life
Qualification of HVAC Systems As Per WHOAditya Sharma
Qualification of HVAC Systems As Per WHO
Documentation requirements to assist in commissioning, qualification and maintenance
Objectives
Commissioning
Qualification
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
Qualification – examples of aspects to consider
Schedule of tests to demonstrate continuing compliance
Cleanroom monitoring program (1)
Cleanroom monitoring program (2)Particles and Microbiological contaminants
Definition of Conditions
examples of aspects to consider in qualification (OQ, PQ)
Maintenance
Inspecting the air handling system
Quality Management Principles
Quality Management System(QMS)
Total Quality Management(TQM)
ISO
ISO 9000
PPT
Seven Quality Management Principles
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence-Based Decision Making
Relationship Management
Statement
Rationale
Key benefits
quality assurance
quality control
gmp
Limit tests, Introduction, Definition,
Limit Test For Chlorides
Limit Test For Sulphates
Limit Test For Iron
Limit Test For Lead
Limit Test For Arsenic
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
2. BIOAVAILABILITY
• It is relative amount of drug from an administered dosage form
which enters the systemic circulation and rate at which the drug
appears in the systemic circulation.
• The extent and rate at which its active moiety is delivered from
pharmaceutical form and becomes available in the systemic
circulation
3. Why do we care about BIOAVAILABILITY?
The “true dose” is not the drug swallowed; BUT is the drug available
to exert its effect.
Bioavailable fraction (F), refers to the fraction of administered dose
that enters the systemic circulation.
F = Bioavailable dose
Administered dose
4. Objectives of bioavailability studies
• Development of new formulation.
• Determination of influence of excipients, patient related factors and
possible interaction with other drugs on the efficiency of absorption.
• Control of quality of a drug product during the early stages of marketing in
order to determine the influence of processing factors, storage, stability on
drug absorption.
• Primary stages of the development of a suitable dosage form for a new
drug entity.
• To formulate a new dosage form of the existing drug molecule which can
be used during emergency
5. REASONS OF POOR BIOAVAILABILITY
Poor aqueous
solubility
Inappropriate
partition
coefficient
First-pass
metabolism
Degradation
due to low pH
in stomach
Degradation
due to
chemical
reactions
taking place in
gastrointestinal
tract
Interaction
with food
Route of
administration
6. HOW TO IMPROVE BIOAVAILABILITY
• By increasing the aqueous drug solubility ie. by making salts of the drug.
• By maintaining the drugs partition coefficient.
• By synthesizing pro drugs.
• Enteric coating of drugs prevents its degradation in stomach pH.
• If food is present in stomach than it may decreases the drugs absorption and for this
the medication can be preferred before meal or after 2-3 hours.
• I/V given drug has highest bioavailability.
7.
8. RELATIVE BIOAVAILABILITY
• Compares the bioavailability of a formulation (A) of a certain drug
when compared with another formulation (B) of the same drug,
usually an established standard
• Fr=AUCA
AUCB
• Eg. Comparison of amoxicillin cap and suspension
9. ASSESSMENT OF BIOAVAILABILITY
➢Pharmacokinetics method – This method is more practical and discriminative.
Pharmacokinetic methods are of two types.
a) Determination of whole blood, plasma or serum concentration
b) Urinary excretion method
➢ Pharmacodynamic methods:
• Acute Pharmacologic Response Method : When bioavailability measurement by pharmacokinetic
method is difficult, an acute pharmacologic effect such as effect on pupil diameter, heart rate or BP can
be useful as an index of drug bioavailability.
• Bioavailability can then be determined by construction of pharmacological effect- time curve as well as
dose response graphs
• Disadvantage: It tends to be complex, expensive, time-consuming and require a sensitive and
quantitative measure of the desired response.
• Therapeutic Response Method: Clinical response of the drug for which it is intended to be used is
measured.
• E.g.: heart rate, body temperature, blood sugar levels, and for anti-inflammatory drugs, reduction in
inflammation is determined.
• Drawbacks: quantification of observed response is too improper to allow for reasonable assessment of
relative bioavailability between two dosage forms of the same drug.
10. A) The blood (or serum or plasma) concentration-time curve -
• Widely used and based on assumption that Pharmacokinetic profile reflects the
therapeutic effectiveness of a drug. Plasma Level- Time Studies:
• Most common type of human bioavailability studies.
• Based on the assumption that there is a direct relationship between the concentration
of drug in blood or plasma and the concentration of drug at the site of action.
• Following the administration of a single dose of a medication, blood samples are
drawn at specific time intervals and analyzed for drug content.
• If the drugs are given to the volunteers through iv dose, the blood samples should be
withdraw after 5min. And the frequency of sampling should be 15min.
11. • A profile is constructed showing the concentration of drug in
blood at the specific times the samples were taken.
• Bioavailability (the rate and extent of drug absorption) is
generally assessed by the determination of following three
parameters. They are..
• Cmax (Peak plasma concentration)
• tmax(time of peak)
• Area under curve
12.
13. AUC: The AUC is proportional to the total amount of drug reaching
the systemic circulation, and thus characterizes the extent of
absorption.
Cmax: Gives indication whether drug is sufficiently absorbed
systemically to provide a therapeutic response.
Tmax: The Tmax reflects the rate of drug absorption, and decreases as
the absorption rate increases.
MEC: The minimum plasma concentration of the drug required to
achieve a given pharmacological or therapeutic response
MSC: plasma concentration of the drug beyond which adverse effects
are likely to happen
14.
15. Urinary Excretion Studies
• Urinary excretion of unchanged drug is directly proportional to plasma
concentration of drug.
• Thus, even if a drug is excreted to some extent (at least 10 to 20%) in the
bioavailability can be determined. eg: Thiazide diuretics, Sulphonamides.
• Method is useful when there is lack of sufficiently sensitive analytical technique
to measure drug concentration.
• Noninvasive method, so better patient compliance.
• This technique of studying bioavailability is most useful for those drugs that are
not extensively metabolized prior to urinary elimination.
16.
17. The three major parameters examined in urinary excretion data are
as follow:
1.(dXu/dt)max : maximum urinary excretion rate, gives the rate of
appearance of drug in the urine is proportional to its concentration
in systemic circulation. Its value increases as the rate of and/or
extent of absorption increases.
2. (tu)max : time for maximum excretion rate, is analogous to the of
plasma level data, its value decreases as the absorption rate
increases.
3. Xu : cumulative amount of drug excreted in the urine is related to
the AUC of plasma level data and increases as the extent of
absorption increases
21. DISSOLUTION
• It is a process by which drug released from solid dosage form and
immediately goes into molecular solution.
• It is a Rate Determining Step.
• If the drug is hydrophilic with high aqueous solubility then dissolution is
rapid and rate determining step in the absorption of such drugs is rate
of permeation through the bio membrane.
• Absorption of such drugs is said to be permeation rate limited or Tran’s
membrane rate limited.
22.
23. NEED FOR DISSOLUTION TESTING:
Evaluation of bioavailability.
Batch to batch drug release uniformity.
Development of more efficacious and therapeutically ACTIVE dosage
forms.
Ensures quality and stability of the product.
24. IN-VITRO DISSOLUTION TESTING MODELS
Non-Sink methods
1) NATURAL CONVECTION NON SINK METHODS:
a) Klein solvmeter method
b) Nelson hanging pellet method
c) Levy static disk method
2) FORCED CONVECTION NON SINK METHODS:
a) Tumbling method
b) Levy or Beaker method
c) Rotating disk method
d) Particle size method
e) USP Rotating basket apparatus
f) USP Paddle apparatus
25. Sink Methods
3) FORCED CONVECTION SINK DEVICES:
a) Wurster pollis adsorption method
b) Partition method
c) Dialysis method s
d) Rotating disk apparatus
4) CONTINOUS FLOW/FLOW THROUGH METHODS:
a) Pernarowski method
b) Langenbucher method
c) Baun and Walker
d) Tingstad and Reigelman
e) Modified column apparatus
f) Takenaka method
26. NATURAL CONVECTION NONSINK METHOD
Klein Solvmeter method:
•Carrier device surrounded by flat and is immersed in
dissolution medium
•When dosage form is placed in the boat the bar moves and as
dosage form dissolves it moves upwards
•Amount of dosage form dissolved is revealed from the difference
in height of bar movement
27. Levy static Disk method:
• Acrylic holder containing dosage form is inserted into a known
volume of medium through rubber stopper.
• The vial is inverted and placed in incubator at 37 C .At specific
time intervals the vial is removed from incubator and samples are
analyzed.
• Disadvantages :- effect of conc. On dissolution medium is ignored
and the surface area of dosage form while dissolving is assumed
constant which is not impractical.
28. FORCED CONVECTION NON SINK METHODS
a. Tumbling Method:
• The Drug/ Dosage form with the dissolution medium is placed in test tube that is in turn clamped to
the revolving drum which is rotated at the speed of 6- 12rpm in water bath at 37 C
• The test tubes are removed and the medium is assayed at regular time points for the dissolved drug
amount
b. Beaker method
• Reported by Levy and Hayes(1960).
• Dissolution medium, 250ml of 0.1N HCl at 37°C placed in a 400ml beaker.
• Agitation by three blade polyethylene stirrer,5cm diameter and rotates at 60 rpm.
• Stirrer immersed to a depth of 2.7 cm in medium and in the center.
• Tablets are placed in a beaker and test was carried out.
• Samples are removed and assayed for the content
29. c. Rotating disk method:
• Developed by late Eino nelson and described by Levy and Sahli.
• In this method ,the drug is compressed in a non-disintegrating disc
without excipients.
• The disc is mounted in a holder so that only one face of the disc is
exposed to the dissolution medium.
• The holder and disc are immersed in medium and held in a fixed
position as in static disc method and rotated at a given speed in
rotating disc method.
• Samples are collected at predetermined times.
• Surface area of the drug through which dissolution occurs is kept
constant –intrinsic dissolution rate.
30. d. USP ROTATING BASKET:
• DESIGN:
Vessel: -Made of borosilicate glass.
-Semi hemispherical bottom
-Capacity 1000ml
Shaft : -Stainless steel 316
-Rotates smoothly without significance wobble(100 rpm)
-Speed regulator
Water bath:-Maintained at 37±0.5ºC
USE: Tablets, capsules, delayed release suppositories, floating dosage
forms.
31. Forced Convection Sink Devices:
A. Wurster-Polli Adsorption Method:
In this method the dissolved drug is adsorbed by charcoal or
bentonite. Care should be taken regarding the adsorbent, adsorbent
should not alter the viscosity of the medium
B. Partition Method:
In this device organic phase is employed to remove the dissolved
drug such that the drug would partition between the lipophilic and
hydrophilic phases. selection of organic phase plays a critical role.
32. Flow Through Devices
a) CONTINUOUS FLOW APPARATUS BY PERNAROWSKI
• It consists of 10 mesh stainless steel basket stirrer assembly with
an adjustable stirrer.
• the chamber is 3 necked flask of 33 mm and the rest two of 20
mm diameter.
• 1L of medium is employed within the flask. the dissolution
characteristics are dependent upon the amount of medium
pumped through the dissolution chamber
33. B. LANGENBUCHER COLUMN
• This device is according to the dissolution basic design .
• The screen is constructed such that the medium flows equally
through the entire cross section in a laminar pattern.
• This is again closed by a secondary screen, filter which prevents
the undissolved drug from being eluted.
34.
35. C. CONTINUOUS FLOW APPARATUS BY TAKENAKA
• The release of drug is measured with the aid of in vitro simulator device
consisting of flow type dissolution container.
• The dosage form is placed in the basket rotating at 94 rpm with 300 ml of
medium.
• Then the medium is removed by collecting reservoir using peristaltic pump.
• Aliquots are withdrawn using syringe and then filtered using Whatman filter
paper and the same volume is
• Replaced immediately with fresh medium.
36.
37. Bioequivalence
• Bioequivalence :- It is a relative term which denotes that the drug
substance in two or more identical dosage forms, reaches the
systemic circulation at the same relative rate and to the same
relative extent i.e. their plasma concentration-time profiles will be
identical without significant statistical differences
• When a generic drug is claimed bioequivalent to a Reference drug,
it is assumed that they are therapeutically equivalent
38. Therapeutic equivalence
Two products are therapeutically equivalent if
• pharmaceutically equivalent
• their effects, with respect to both efficacy and safety, will be
essentially the same as derived from appropriate studies including
bioequivalence studies, pharmacodynamic studies, clinical studies,
in vitro studies
39.
40. TYPES OF BIOEQUIVALENCE STUDIES
•Bioequivalence can be demonstrated either –
In vivo, or
In vitro.
41. In vivo bioequivalence studies are conducted in the usual manner as
discussed for bioavailability studies, i.e. the pharmacokinetic and the
pharmacodynamic methods.
1. Pharmacokinetic Methods
a)Plasma level-time studies
b) Urinary Excretion studies
2. Pharmacodynamic Methods
a)Acute pharmacological response
b)Therapeutic response
42. In vitro studies, i.e. dissolution studies can be used in lieu of
in vivo bioequivalence under certain circumstances, called
as biowaivers(exemptions)
1. The drug product differs only in strength of the active substance It contains,
provided all the following conditions hold –
• Pharmacokinetics are linear.
• The qualitative composition is the same.
• The ratio between active substance and the excipients is the same, or (in the case of
small strengths) the ratio between the excipients is the same.
• Both products are produced by the same manufacturer at the same production site.
• A bioavailability or bioequivalence study has been performed with a original
product.
• Under the same test conditions, the in vitro dissolution rate is the same
51. METHODS TO ENHANCE THE DISSOLUTION
RATE
1. Increase in the effective surface area of the drug.
2. Particle size reduction
3. Incorporation of surface active agents in formulation. EG non-ionic surfactants like
polysorbates are widely used.
4. Solute-Solvent complexation reactions.
5. Polymorphism. E.g. Riboflavin exist in 1,2,3 forms but form 3 is 20 times more
soluble than 1
6. Molecular encapsulation with cyclodextrins or complexation with
cyclodextrins.
7. Prodrug approach.
8. Salt formation of drug.
52. References
• Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence
Studies. 3. Chapman Hall/CRC Press, Taylor& Francis; New York, New York, USA:
2008.
• Balant LP. Is there a need for more precise definitions of bioavailability? European
Journal of Clinical Pharmacology. 1991;40:123–126.
• Chen ML, Lesko L, Williams RL. Measures of exposure versus measures of rate
and extent of absorption. Clinical Pharmacokinetics. 2001;40:565–572.
• Chow SC, Shao J. An alternative approach for the assessment of bioequivalence
between two formulations of a drug. Biometrical Journal. 1990;32:969–976
• http://www.slideworld.com/slideshow.aspx/Bioavailability-and-
Bioequivalenceppt- 2810356