Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Physics of Tablet compression is very useful during study of the tablet. It contains the mechanism of tablet compression. It also contains the process of tablet compression.
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Physics of Tablet compression is very useful during study of the tablet. It contains the mechanism of tablet compression. It also contains the process of tablet compression.
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
QbD is new concept in pharmaceutical industries which is beneficial for producing and maintaining quality in product. With help of QbD a quality is built in product during manufacturing.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
The Pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
Quality cannot be tested into products; it has to be built in by design.
Antimicrobial resistance is the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals, and antifungals) from working against it.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
Bioavailability is defined as rate and extent of absorption of the unchanged drug from its dosage form and become available at the site of action. Solubility is the most important physical characteristic of a drug for its oral bioavailability, formulation, development of different dosage form of different drugs, therapeutic efficacy of the drug and for quantitative analysis. Proper selection of solubility enhancement method is the key to ensure the goals of a good formulation.
Personalised Medicine is a young but rapidly advancing field.
The term 'Personalised Medicine' is described as providing "the right patient with the right drug at the right dose at the right time".
Suprachoroidal drug delivery system is a novel drug delivery used in opthalmology.. It is a novel approach by which ocular side effects can be minimized.
Ayurveda vs Allopathy : Look, Think & DecideKushal Saha
Life is a running race now a day. We need quick but efficient relief. Modern medicine or Allopathic medicine is saving numerous lives since the time of World War II. Especially in emergencies like viral attacks, epidemic and surgical cases the allopathic system has been so impressive and approved by all over the world. Presently, use of computers is making it more accurate. But, this rapid relief method of medicine or you can say "Short-Cut" method of relief is also producing several adverse effects which cause severe problems like multi organ failure etc. We're taking medicine to get rid of a side effect created by another and that also shows another side effect and thus we're becoming medicine prone.
So I'm trying to look behind, in the pages of Vedas, our traditional medicinal system – Ayurveda; Which not only cures the disease but also teaches us how to stay healthy. They've very less side effects as they are naturally derived.
But, here also one question arises. Can the so called backdated ayurveda satisfy our need for being healthy in this modern era?
So, here I'm presenting the basic comparison between Ayurveda and Allopathy. Now you have to look, think and decide which you should choose for your betterment.
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
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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Hot Selling Organic intermediates
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
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!
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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
2. INTRODUCTION
Traditional approach of formulating a new drug product is an
exhaustive task and involves a number of resources like man,
money, time and experimental efforts. While, using this Quality by
Design (QBD) approach one can get the pharmaceutical product of
desired (best) quality with minimizing above resources as well as
knowing the influence of one factor over the desired associated
process. Hence aim of this study is the understanding of QBD
approach to design product and manufacturing process to get
desired pharmaceutical product. QBD follows the concepts of ICH
guidelines (Q8, Q9 & Q10) which are essential for processing a
pharmaceutical process. In this presentation we are going to focus
upon QBD for immediate release dosage forms.
3. Overview of QBD
Product Design
& Understanding
Process Design &
Understanding
Control
Strategy
Continuous
Improvement
Target
Product
Profile
4. Elements of QBD
Quality target product profile (QTPP)
Define CQA (Critical Quality Attribute)
Perform Risk Management
Link raw materials attributes & process
parameter to CQAs
Design and implement of a control strategy
5. Quality target product profile(QTPP) for ANDA
Products
QTPP is a prospective summary of the quality characteristics of a
drug product that ideally will be achieved to ensure the desired
quality, talking into account safety and efficacy of the drug
product.
The QTPP is an essential element of QBD approach and forms
the basis of design of generic product.
For ANDA’s, the target should be defines early in the development
based on the properties of the drug substances, characterization
of the product and intended patient population.
The QTPP includes all product attributes that are needed to
ensure equivalent safety and efficiency.
Based on the clinical and pharmacokinetic (PK) characteristics as
well as invitro dissolution and physicochemical characteristics of
the product, a QTPP is defined.
6. QTPP Components for IR tablets
QTPP Elements Target Justification
Dosage form Tablet Pharmaceutical equivalence
requirement: same dosage
form
Dosage design Immediate release tablet
without a score or coating
Immediate release design
needed to meet label claims
Route of administration Oral Pharmaceutical equivalence
requirement: same route of
administration
Dosage strength 20 mg Pharmaceutical equivalence
requirement: same strength
Pharmacokinetics Immediate release enabling
Tmax in 2.5 hours or less;
Bioequivalent to RLD
Bioequivalence requirement
Needed to ensure rapid onset
and efficacy
Stability At least 24-month shelf-life
at room temperature
Equivalent to or better than
RLD shelf-life
7. QTPP Elements Target Justification
Drug
product
quality
attributes
Physical
Attributes
Pharmaceutical equivalence requirement: Must
meet the same compendial or other applicable
(quality) standards (i.e., identity, assay, purity,
and quality).
Identification
Assay
Content
Uniformity
Dissolution
Degradation
Products
Residual
Solvents
Water Content
Microbial
Limits
Container closure system
Container closure
system qualified as
suitable for this drug
product
Needed to achieve the
target shelf-life and to
ensure tablet integrity
during shipping
Contd…
8. Critical Quality Attributes (CQA)
A critical quality attribute (CQA) is a “physical, chemical, biological
or microbiological property or characteristics that should be within
an appropriate limit, range or distribution to ensure desired product
quality.
CQA for IR tablets:
• Assay,
• Content uniformity,
• Dissolution,
• Disintegration of products,
• Residual solvents,
• Water content,
• Microbial limits.
10. • A risk management of the drug substance attributes is
performed to evaluate the impact that each attribute could have
on the drug product CQA’s.
• The two primary principles that should be considered when
implementing quality risk management are-
I. The evaluation of the risk to quality should be based on
scientific knowledge and ultimately linked to the protection of
the patient.
II. The level of effort, formality and documentation of the quality
risk management process should be commensurate with the
level of risk.
• Based upon the physicochemical and biological properties of the
drug substances, the initial risk assessment of drug substance
attributes on drug product CQAs should be done.
Risk Assessment of Drug Substances Attribute
14. Control Strategy
The control strategy is a planned set of controls derived from current
products and process understanding, that assures process performances
and product quality.
Control Strategy for raw material attributes:
The drug substance particle size distribution limits arise from a
combination of its impact on binding and invivo performance.
Control Strategy for roller compaction & integrated milling:
The intent of control strategy for roller compaction is to maintain ribbon
density with required range to ensure drug product CQAs are met. For
milling, the mill screen orifice size is specified to ensure that the granule
size distribution remains within the acceptable range.
Control Strategy for blending and lubrication:
The control strategy for blending the granules with the talc is to
maintain the targeted number of revolutions. For granule lubrications
with Mg stearate, the control strategy is to adjust the number of
revolutions based on the blender capacity used and the volume of
blender.
15. Contd…
Control Strategy for tablet compression:
The control strategy for tablet compression is to maintain the in
process tablet attributes of weight, hardness, thickness, friability
and disintegration within the required ranges.
The target compression force required to produce tablets with
desired hardness, and ultimate friability and disintegration is
established at the beginning of each run.
After tablets with target weight and hardness are obtained during
the tablet press set up, the upper punch penetration depth and the
fill depth are fixed.
The compression force is continuously measured throughout the
run for each tablet and compared to the target compression force.
16. Product Lifecycle Management & Continual
Improvement
Upon approval, the manufacturing process for IR tablets will be validated
using the lifecycle approach that employs risk based decision making
throughout the drug product lifecycle as defined in the FDA process
validation guidance.
There are 3 stages in Product lifecycle management:
The commercial manufacturing process was defined baaed on knowledge
gained through development and scale up activities.
The goal of stage 2 is to evaluate if the process is capable of reproducible
commercial manufacturing facility will be designed according to cGMP
regulations.
Throughout the product lifecycle, the manufacturing process performance
will be monitored to ensure that it is working as anticipated to deliver the
product with desired quality attributes, process stability and process
capability will be measured and evaluated if any unexpected process
variability is detected, appropriate action will be taken to correct, anticipate
and prevent future problems so that the process remain in control as part of
the continual improvement of the drug product.