The document discusses Investigational Medicinal Product Dossier (IMPD) and Investigators Brochure (IB). It provides details on the components and information that should be included in an IMPD and IB. An IMPD includes quality, non-clinical and clinical data on an investigational product and is required for approval of clinical trials in the EU. It also lists additional documents that must accompany the IMPD like the protocol, investigator information and labeling. An IB provides investigators information on the rationale, safety monitoring and risks of an investigational product from pre-clinical and clinical studies to facilitate trial conduct. It outlines the content and sections that should be contained in an IB.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
CMC(CHEMISTRY,MANUFACTURING AND CONTROL).pptxJubinNath2
It includes the details about CMC(Chemistry,manufacturing and control). It includes the importance of CMC, CMC regulatory affairs, CMC review at IND stage.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Investigation of Medicinal Product Dossier (IMPD) and Investigator Brochure (...Tanvi Mhashakhetri
Contents:
European Medicines Agency (EMA)
IMPD Introduction
Contents of IMPD
Objectives
Scope
Introduction of IB
General Consideration
Content of IB
European Medicines Agency (EMA)
It is a decentralized agency of the European union.
The Management Board is the European Medicines Agency’s integral governance Body.
The Agency is responsible for the scientific evaluation, supervision and safety monitoring of the medicines developed by pharmaceutical companies use in EU.
EMA protects public and animal health in 27 EU member states, as well as the countries of the European economic area , by ensuring that all medicines available on the EU market are safe, effective and of high quality.
History
European medical agency was found in 1995, has worked across the EU and globally to protect public and animal healty by assessing medicines to rigorous scientific standards and providing with independent, science-based informations on medicines.
EMA has 20 year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the developments of medicines.
In first two decades, the agency recommended the authorization of the total of 975 humans and 188 veterinary medicines.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
CMC(CHEMISTRY,MANUFACTURING AND CONTROL).pptxJubinNath2
It includes the details about CMC(Chemistry,manufacturing and control). It includes the importance of CMC, CMC regulatory affairs, CMC review at IND stage.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Investigation of Medicinal Product Dossier (IMPD) and Investigator Brochure (...Tanvi Mhashakhetri
Contents:
European Medicines Agency (EMA)
IMPD Introduction
Contents of IMPD
Objectives
Scope
Introduction of IB
General Consideration
Content of IB
European Medicines Agency (EMA)
It is a decentralized agency of the European union.
The Management Board is the European Medicines Agency’s integral governance Body.
The Agency is responsible for the scientific evaluation, supervision and safety monitoring of the medicines developed by pharmaceutical companies use in EU.
EMA protects public and animal health in 27 EU member states, as well as the countries of the European economic area , by ensuring that all medicines available on the EU market are safe, effective and of high quality.
History
European medical agency was found in 1995, has worked across the EU and globally to protect public and animal healty by assessing medicines to rigorous scientific standards and providing with independent, science-based informations on medicines.
EMA has 20 year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the developments of medicines.
In first two decades, the agency recommended the authorization of the total of 975 humans and 188 veterinary medicines.
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
IND Data Requirements and US FDA Submission Process.pdfProRelixInfo
A clinical trial is a culmination of the several stages of a drug or medical device development program that begins with the discovery of a candidate molecule followed by preclinical toxicology studies in ex vivo, in vitro, and animal models. Once the candidate molecule shows promising results in these stages, the next step involves clinical studies on human subjects. Drug testing in humans is often the most lengthy and expensive phase of the drug development timeline, and therefore requires extensive effort and careful execution to maximize the candidate’s chances of success. In addition to scientific evaluation, clinical studies require approval by the United States Food and Drug Administration (US FDA), the regulatory authority in the United States to administer the experimental drug in humans as well as ship it across state lines. This approval comes in the form of an Investigational New Drug (IND FDA) application that is required to be submitted by sponsors, investigators, or research institutes to the FDA to commence studies on human participants. The following figure shows the various stages of the drug development program (Figure 1) marking IND submission on the timeline.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
this presentation mainly based on the regulatory aspects of packaging and gives all significance about packaging regulations,help in pharma or biotechnology .
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
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
1. IMPD & IB
Presented by – Snehankit Satish Gurjar
Guide – Dr. S. D. Pande
Seminar for completion of M. Pharm. 1st sem.
(Pharmaceutics)
VBCP, Amt.
2. IMPD
IMPD or Investigational Medicinal Product Dossier is one of the several pieces of Investigational Medical
Product (IMP)and it is the basis for approval of clinical trials by the competent authorities in the European
Union Member State.
The directive introduced a harmonized procedure for the authorization to perform a clinical study in any one of
the European Union Member State after Clinical Trial Directive (2001/20/EC) came into force in April 2001.
The IMPD includes summaries of information related to
- Critical analysis of the non-clinical and clinical data in relation to the potential risks and benefits of the
proposed study have to be part of the IMPD.
- Investigational Medicinal Product’s manufacture and clinical data, quality, data from clinical use and
non-clinical studies
- An overall assessment of risk to benefit
- Presented by Snehankit Satish Gurjar 2
3. Additional components which should accompany the IMPD:
o Application form
o Covering latter
o Receipt of confirmation of EudraCT number
o List of all Competent authorities (CAs) where application has been submitted
o Copy of any scientific advice
o Any letter of authorization for the use when application is not the sponsor
o Any letter of concern received from any of Member State
o Information content form
o Confirmation that CA will accept application in English
o Protocol with any amendment
- Presented by Snehankit Satish Gurjar 3
4. o Subject information (If any)
o Arrangement for recruitment of subjects
o Peer review of trial if available
o Ethical assessment by principle investigator
o Report of any trial with sample IMP
o Investigators Brochure (IB)
o Example of label in the national language
- Presented by Snehankit Satish Gurjar 4
5. Following is a listing of the data that should be included in the IMPD:
1. Quality data including summaries of chemical, pharmaceutical and biological data on the IMP. Data should be
based on the IMPs to be used for a clinical trials whose manufacturing complies with the principle of Good
Manufacturing practices (GMP)
Applicants should also supply the following-
i) A copy of the manufacturing authorization stating the scope of the authorization if the IMP is manufactured
in EU and does not have a marketing authorization in the EU
ii) If the IMP is not manufactured in the EU and does not have a marketing authorization in the EU
iii) Certification of the GMP status of any active biological substance
iv) Compliance with GMP at least equivalent to EU GMP
v) Certification of the Qualified Person that the manufacturing site works in
- Presented by Snehankit Satish Gurjar 5
6. 2. Previous clinical trial and human experience data
3. nonclinical pharmacology and toxicology data
4. Overall risk and benefit assessment section
- Presented by Snehankit Satish Gurjar 6
7. Simplified IMPD
In certain situation, e.g. where the Investigational Medical Product has already been authorized as a medicinal
product in one of the EU Member States or where clinical studies with the IMP have already been approved by a
Member State, a simplified IMPD will be sufficient.
Substantial amendments to IMPD
The assessment of an IMPD is focused on patient safety and any risk associated with the IMP
Whenever any potential new risks are identified the IMPD has to be amended to reflect the change
This may be the case for changes in IMP impurities, microbial contamination, viral safety, TSE and the some
particular cases to stability when toxic degradation products may be generated
- Presented by Snehankit Satish Gurjar 7
8. INVESTIGATIONAL BROCHURE (IB)
Investigation Brochure (IB) is a compilation of the clinical and non clinical data on the investigational
product/products that are relevant to the study of product/products in human subjects.
• Its purpose is to provide the investigators and other involved in the trial with the information to
facilitate their understanding of the following:
I. The rational (The set of reason or a logical basis)
II. Their compliance with many key features of protocol, such as the – dose, dose frequency or dose intervals
III. Methods of administration , and safety monitoring procedures.
- Presented by Snehankit Satish Gurjar 8
9. • The information should be presented in concise and simple manner.
• I.B. enables a clinician, or a potential investigator , to understand it and make his/her own unbiased risk
benefit assessment of appropriateness of purposed trials.
• For this reason, a medically qualified person should generally participate in the editing of an I.B.
• The I.B. should be revived at least annually and revised as necessary in compliance with the spencer's
written procedures. The revised version should be included in IND (Investigational New Drug) annual
report.
• Generally sponsor is responsible for ensuring that an up-to-date I.B. is made available to the
Investigator(s).
• The following should be included in the I.B.:
i. Title page
ii. Confidentiality statement
iii. Contents of the I.B.
- Presented by Snehankit Satish Gurjar 9
10. TITLE PAGE
Title page should include following components:
Spencer's name
Product
Research number
Name(s)- Chemicals, Generic (if approved)
Trade name(s) – If legally permissible and approved by sponsor
Edition number
Release date
Replaces previous edition number
date
- Presented by Snehankit Satish Gurjar 10
11. Contents of I.B.
Table of contents of investigational broacher-
• Confidentiality statement (optional)
• Signature page (optional)
1. Table of contents
2. Summary – not exceeding 2 pages – highlight the significant physical, chemical, pharmaceutical,
pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available on Investigational
product.
3. Introduction – Chemical name, active ingredient, pharmacological class, anticipated therapeutic/ diagnostic
indicator(s), general approach to be followed in evaluating of Investigational Product.
4. Description of physical, chemical and pharmaceutical properties of product – storage and handling of
Investigational Product, any structural similarities with the other known compounds.
- Presented by Snehankit Satish Gurjar 11
12. 5. Non clinical trials :
i. Nonclinical pharmacology –
A summery of pharmacological the investigational product studied in animal should be included.
ii. Pharmacokinetics and product metabolism in animals –
A summery of ADME and biological transformation and disposition of the investigational product in all species
studied should be given
iii. Toxicology –
A study of toxicological effects found in relevant studies conducted in different animal species like,
• single dose
• Repeated dose
• Carcinogenicity
• Special studies (irritancy, sensitization)
• Reproductive toxicity
• Genotoxicity (Mutagenicity)
- Presented by Snehankit Satish Gurjar 12
13. 6. Effect in humans :
A through discussion of the known effects of the investigational product(s) in human should be provided,
including information on pharmacokinetics, metabolism, pharmacodynamics, dose response, safety, efficacy and
other pharmacological activities.
i. Pharmacokinetics and product metabolism in humans -
A summery of information on pharmacokinetic of the investigational product(s) should be presented
ii. Safety and efficacy -
A summery of information should be provided about the investigational product’s safety, efficacy and
pharmacodynamics
iii. Marketing experience -
The I.B. should identify countries where investigational product has been marketed or approved
- Presented by Snehankit Satish Gurjar 13
14. 7. Summary of data and guidance for the investigator –
This section should contain nonclinical and clinical data of Investigational Product (I.P.)
• Investigational Broacher provide investigator a clear understanding of
a) the possible risks
b) Adverse reaction
c) Observation and precautions needed for the clinical trials
• It should also contain
i. NB: Reference no.
ii. Publications
iii. Reports [this references should be found at the end of each chapter Appendices (if any)]
- Presented by Snehankit Satish Gurjar 14
15. REFERTENCES
New Drug Approval Process, By: Richard Guarino, Page no.:136-144
https://www.slideshare.net/Zahid1392/impd-amp-ib
https://www.slideshare.net/NaveenBalaji32/investigators-bronchure-investigational-medicinal-product-dossier-ib-
amp-impd-naveen-balaji
- Presented by Snehankit Satish Gurjar 15