Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
The Common Technical Document (CTD) is a standardized format for regulatory submission of information on drugs, biologics, and medical devices to regulatory authorities in different countries. The CTD is designed to simplify the submission and review process by providing a consistent format and organization of information that can be easily understood by regulatory authorities in different regions.
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
The Common Technical Document (CTD) is a standardized format for regulatory submission of information on drugs, biologics, and medical devices to regulatory authorities in different countries. The CTD is designed to simplify the submission and review process by providing a consistent format and organization of information that can be easily understood by regulatory authorities in different regions.
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
common technical document and electronic document by akshay trivedi
The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Common Technical Document is divided into five modules: Administrative and prescribing information
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documen- tation included in an application for the registration of a human pharmaceutical product..
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
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
common technical document and electronic document by akshay trivedi
The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Common Technical Document is divided into five modules: Administrative and prescribing information
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documen- tation included in an application for the registration of a human pharmaceutical product..
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
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.
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
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.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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.
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Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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!
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
1. BHARAT PHARMACEUTICAL TECHNOLOGY
TOPIC: OVERVIEW OF ICH GUIDELINES
PREPARED BY
Name:- Bishal Bhattacharjee
Stream:- B.Pharm
Year:- 4th year/ Final year
Sem:- 7th sem
2. CONTENTS
•Introduction
•Objective of ICH
•QSEM guidelines
•Common Technical Document
•Organization & Advantages of Common Technical Document
•Silent benefits & Limitations of Common Technical
Document
•Electronic Common Technical Document
•Benefits & Advantages of Electronic Common Technical
Document
3. INTRODUCTION
The International Council for Harmonization(ICH) of technical
requirements for pharmaceuticals of human use brings together the
medicines regulatory authorities and pharmaceutical industry
around the world.
ICH is a joint initiative involving both regulators and research
based industry representatives of the European Union, Japan and
the US in scientific and technical discussions of the testing
procedures required assess and ensure safety, quality and efficacy
of medicines.
4. OBJECTIVE OF ICH
To increase international harmonization of technical
requirements to ensure safe, effective and high quality
medicines are developed.
To harmonize technical requirements for registration
or marketing approval.
To promote public health.
To prevent unnecessary duplication of clinical trials on
humans.
To minimize the use of animal testing without
compromising safety and effectiveness of drug.
5. QSEM GUIDELINES
Q: Quality guidelines- It includes stability, impurities,
testing and GMP
S: Safety guidelines- It include carcinogenicity,
genotoxicity, reprotoxicity.
E: Efficacy guidelines- It includes clinical pharmacy
genomics.
M: Multidisciplinary guidelines- It includes medical
dictionary or regulatory activities, electric standard on
clinical safety studies, common technical document.
6. COMMON TECHNICAL DOCUMENT(CTD)
CTD is an internationally agreed “well structured common
format” for the organization of the technical requirements that
is to be submitted to the regulatory authority as an application
for the registration of pharmaceuticals for human use in all
three ICH regions:
1. European Medicines Agency(EMEA, Europe)
2. Food & Drug Administration(FDA, USA)
3. Ministry of health, labor & welfare(MHLW, Japan)
In July 2003, the CTD became the mandatory format for new
drug application in the EU & Japan and the strongly
recommended format of choice for NDAs submitted to the
FDA. It has been adopted by several other countries including
Australia, Canada & Switzerland(2004).
7. ORGANIZATION OF CTD
It is organized into:
1. Module A: General Information
2. Module B: CTD summaries
3. Module C: Quality
4. Module D: Nonclinical study reports
5. Module E: Clinical study reports
ADVANTAGES OF CTD
1. To save time and resources
2. To facility regulatory review and
communications
3. Appropriate for the data
4. Easy to understand and evaluation of
data
8. SILENT BENEFITS OF CTD
• More "reviewable” applications
• Complete, well-organized submissions
• More predictable format
• Easier exchange of information
• Easier analysis across applications
LIMITATIONS OF CTD
• CTD is only a format, its not a single dossier with a single
content
• Legal requirements differ in the different regions
• Pharmacopoeias are not harmonized
• Applicant may have regional preferences
• ICH guidelines have not yet harmonized in all requirements
9. ELECTRONIC COMMON TECHNICAL DOCUMENT
The electronic Common Technical Document(eCTD) is an
interface and international specification for the Pharmaceutical
Industry to agency transfer of regulatory information. The
specification is based on the Common Technical
Document(CTD) format and was developed by the International
Council for harmonisation(ICH).
The eCTD allows submission builders to map to documents
within and across all submissions and applications. This feature
can save time and money, but only if it is set up and handled
effectively from the beginning of the product IND application.
10. BENEFITS OF eCTD
1. Reusable content
2. Better document management
3. Metadata corrections
4. Better life-cycle capabilities
ADVANTAGE OF eCTD
1. Reviewers are already familiar with the content and
document standards
2. Local affiliates can review updates in real-time
3. Handling, managing & archiving trial and
document essential information is less time-
consuming
4. Documents are easily accessible via search &
tracking
The International Council for Harmonization of technical requirements for pharmaceuticals for human use brings together the medicines regulatory authorities and pharmaceutical industry around the world.