The document discusses CTD (Common Technical Document) and eCTD (electronic Common Technical Document). CTD is an internationally agreed format for organizing technical documents for new drug applications. It was created to harmonize application formats between regions like the US, EU, and Japan. eCTD builds upon CTD by allowing electronic submission and review of applications using an XML structure for easy transfer and organization of information. Both CTD and eCTD aim to streamline the drug approval process globally by creating standardized common formats for application dossiers.
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.
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.
CTD is common technical document for submission of dossier and widely accepted format for ease of submission and evaluation purpose.
TRS 961, Annex 15, Guidelines on submission of documentation for a multisource (generic) finished product. General format: preparation of product dossiers in common technical document format
Objectives of CTD guidelines
To significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals
To facilitate regulatory reviews and communication with the applicant by a standard document of common elements
To simplify the exchange of regulatory information between Regulatory Authorities
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..
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
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
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.
CTD is common technical document for submission of dossier and widely accepted format for ease of submission and evaluation purpose.
TRS 961, Annex 15, Guidelines on submission of documentation for a multisource (generic) finished product. General format: preparation of product dossiers in common technical document format
Objectives of CTD guidelines
To significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals
To facilitate regulatory reviews and communication with the applicant by a standard document of common elements
To simplify the exchange of regulatory information between Regulatory Authorities
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..
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
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
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
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
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ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
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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.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
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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.
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
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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.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
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Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
CTD and eCTD.pptx
1. CTD and eCTD
Prepared by : Gaurav R. Panchal Guided by : Ms. Hardi Joshi
M.Pharm QA (sem 1) Assisstant Professor, GSP-GTU
1
2. CTD (Common Technical Document)
• The Common Technical Document is a set of specification for application
dossier for the registration of medicines.
• It is an internationally agreed “well structured common format” for the
organization of the technical requirement authority as an application for the
registration of pharmaceuticals for human use in all three ICH regions (USA,
Europe, Japan).
• It was agreed in Nov. 2000 in San Diego. USA.
• In July 2003, CTD became mandatory format for new drug application in the
EU and Japan, and strongly recommended the format of choice of NDAs
submitted to the FDA.US.
• It is maintained by ICH (International Council on Harmonization).
2
3. CTD
Need for CTD :
• Substantial documentation and data are required in submission for import
/manufacture and marketing approval of drugs for human use, resulting in
large, complex applications.
• Till date, applicants have used many different approaches in organizing the
information and difference in organization of data in each application has
made reviewing more difficult and can lead to omission of critical data or
analyses.
• Such omissions can result in unnesccesary delays in approvals.
• Thus, a common format of submission will help in overcoming these
hurdles.
3
4. CTD
Need for CTD :
• Prior to the implementation of the Common Technical Document (CTD) in
2002, each of the three major regulatory regions (European Union (EU),
USA, and Japan) had its own set of guidelines and format for the
submission of a regulatory dossier to obtain marketing approval for a new
drug or a variation to the licensing of an existing drug.
• In Japan, the GAIYO was required, which organised and presented a
summary of the technical information; in Europe, Expert Reports and
Tabulated Summaries were required and Written Summaries were
recommended; and in the USA, the Food and Drug Administration (FDA)
had guidance documents regarding the format and content of the New
Drug Application (NDA).
4
5. CTD
Need for CTD (Contd.) :
• To avoid the need to generate and compile different registration dossiers,
this guideline describes a format for the Common Technical Document that
will be acceptable in all three regions..
• In 2000, representatives from the European Medicines Agency (EMA), the
USA FDA, and the Ministry of Health, Labour, and Welfare in Japan
developed a set of guidelines defining the structure and content of the
dossier for an application for the registration of a new medicine that could
be used across all three regions.
• Now it is adopted by Switzerland(SwissMedic), Canada(Health Canada),
Australia(TGA), etc.
5
6. CTD
Scope :
• This guideline primarily addresses the organisation of the information to be
presented in registration applications for new pharmaceuticals (including
biotechnology-derived products).
• This guideline is not intended to indicate what studies are required.
• It merely indicates an appropriate format for the data that have been
acquired.
• Applicants should not modify the overall organisation of the Common
Technical Document as outlined in the guideline.
• However, in the Nonclinical and Clinical Summaries, applicants can
modify individual formats if needed to provide the best possible
presentation of the technical information, in order to facilitate the
understanding and evaluation of the results
6
7. CTD
Objectives :
• Avoid duplicate animal and human testing.
• More economical use of human, animal and material resources.
• Elimination of unnecessary delays in global development
• Fast availability of new medicines
• Maintain safeguards on quality, safety, efficacy and regulatory obligations
to protect public health.
• Reduce time and resources used to compile applications
7
8. CTD
Organisation :
Module 1: Administrative information and prescribing information
Module 2: Overviews and Summaries of Modules
Module 3: Quality (pharmaceutical documentation)
Module 4: Non-clinical reports (pharmacology/ toxicology)
Module 5: Clinical study reports (clinical trials).
8
10. CTD
Module : 1 Administrative and prescribing information
• It contains documents specific to each region.
• Eg. Application form regarding the prescribing information, proposed
label.
• This module is not part of CTD.
• The content and format of this module can be specified by the relevant
authorities.
10
11. CTD
Module : 1 (contd.)
1. Cover Letter
2. Comprehensive Table of Content
3. Application Form
4. Product information
a) SPC’s, Labelling and Packaging
b) Mock-up
c) Specimen
d) Consultation of target special group
5. Information about the Experts
6. Specific Requirements for different types of application
11
12. CTD
7. Environmental Risk Assessment
8. Information relating to Orphan Market Exclusivity
9. Information relating to Pharmacovigilance
10. Information relating to clinical trials
11. Information relating to pediatrics
12. Response to Queries
13. Additional data
12
13. CTD
Module : 2 Quality Overall Summaries (QOS)
• It contains seven sections that should be maintained in following order :
1. Table of contents
2. Introduction
3. Quality Overall Summary
4. Non-clinical Overwiew
5. Clinical Overview
6. Non – clinical Written and tabulated Summaries
7. Clinical Summary
13
14. CTD
Module 2 (contd.) :
• The quality overall summary (QOS) is a summary of the chemical and
pharmaceutical data in the dossier (including data for
biological/biotechnological products).
• The structure of the QOS broadly follows the structure of the data included
in Module 3.
• The QOS should not include information that has not already been
included in Module 3 or in other parts of the CTD.
• The aim of the QOS is to discuss the critical parameters of the product, but
it should also address issues that arose during development and provide
justification for instances where guidelines were not followed etc.
14
15. CTD
Module 2 (contd.) :
• The main purpose of the Non-Clinical Written and Tabulated Summaries is
to provide a comprehensive factual summary of the non-clinical
information on pharmacology, pharmacokinetics, and toxicology.
• The interpretation of the data, the clinical relevance of the findings, any
association between non-clinical findings and quality aspects of the IMP,
and any implications of non-clinical findings for the safety of the IMP in
humans should be addressed in the Non-Clinical Overview.
15
16. CTD
Module 2 (contd.) :
• Clinical Overview is a key document in the CTD dossier. The Clinical
Overview is divided into six sections: product development rationale,
biopharmaceutics, clinical pharmacology, efficacy, safety, and risk/benefit
conclusions.
• The Clinical Summary is divided into sections covering biopharmaceutics
and associated analytical methods, clinical pharmacology, efficacy, and
safety.
16
17. CTD
Module 3 :
• It presents the chemistry, manufacturing, and controls reports for the
product included in the registration dossier.
• The section of the application covering chemical and pharmaceutical data
for biological/biotechnological products.
• Information on quality should be presented in structure and format.
• The Quality section of CTD provides a harmonized structure and format
for presenting (CMC) information in registration dossier.
17
18. CTD
Module 3 (contd.) :
• The main headings in this section are as follows:
1. Table of Content
2. Body of Data
a) Drug Substances
b) Drug Product
3. Literature References
18
19. CTD
Module 4 :
• It presents the non-clinical reports included in the dossier.
• The structure and content of Module 4 is specified in the ICH M4S
guidelines.
• The main headings in this section are as follows:
1. Table of contents of Module 4
2. Study reports
a) Pharmacology
b) Pharmacokinetics
c) Toxicology
19
20. CTD
Module 5 : Clinical Study reports
• Module 5 presents the clinical reports included in the dossier.
• The structure and content of Module 5 is specified in the ICH M4E
guidelines.
• main headings in this section (that must not be altered) are as follows:
1. Table of contents of Module 5
2. Tabular listing of all clinical studies
3. Clinical study reports
a) Reports of biopharmaceutic studies
b) Reports of studies pertinent to pharmacokinetics using human
biomaterials
20
21. CTD
Module 5 (contd.) :
c) Reports of human pharmacokinetic (PK) studies Reports of human
pharmacodynamic (PD) studies
d) Reports of efficacy and safety studies
e) Reports of post-marketing experience
f) Case report forms and individual patient listings
3) Literature references
21
22. eCTD (Electronic Common Technical Document
• After decades of using paper, the goal is the electronic transfer of drug
application and their review across submission formats, procedures, and
reasons came in electronic technical document.
Defination :
“eCTD is an interface and international specification for the pharmaceutical
industry to agency transfer of regulatory information.”
• The focus of the specification is to provide the ability to transfer the
registration application electronically from industry to regulatory authority.
22
23. eCTD
Reasons :
• Manages the large data for entire sybmission and for each document within
the submission.
• XML backbone allows the eCTD submission to be viewed via a web
browser and canbe loaded on a web server.
• The file formats that can be included in the eCTD are Portable document
Format (pdf) and XML.
23
24. eCTD
eCTD submission are accepted for :
• Investigational New Drug (INDs)
• New Drug Application (NDAs)
• Abbreviated New Drug Applications (ANDAs)
• Biologics License Application (BLAs)
• All the application following the submission of the above stated
applcations.
• All the Master Files which are part of any above mentioned applications
24
25. eCTD
Advantages :
• Allows agencies to upload sequences automatically with the help of XML
backbone.
• Reviewers can refer the information easily with of hyperlinks
• No need to scan, copy or store paper documents.
• Changes and updates made to the dossiers can be easier identified.
• Easy product lifecycle tracking.
• Simultaneous accessibility of documents is possible.
25