The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
A small description of what is pharmaceutical waste, hospital and otherwise, some regulations and some of the practices used to manage such waste.
This presentation was done just under 10 minutes which was the time limit.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Pharmaceutical Waste Treatment and Disposal Practicesrekhac86
Treatment of pharmaceutical waste is very important because improper disposal may also have an adverse effect on land values, create public nuisances, otherwise; the failure or inability to salvage and reuse such materials economically results in the unnecessary waste and depletion of natural resources
Abbreviated New Drug Application (ANDA)RaghaviPillai
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
GLOBAL SUBMISSION OF IND, NDA, ANDA.pdfLokeshThakre6
It's important to note that the specific requirements and processes for INDs, NDAs, and ANDAs may vary between regulatory authorities in different countries. The descriptions provided here are general and based on the common practices in the United States.
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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Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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.
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.
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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.
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
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
1. 1
New Drug Application[NDA]
Mr. Sagar Kishor Savale
[Department of Pharmaceutics]
avengersagar16@gmail.com
2015-2016
Department of Pharmacy (Pharmaceutics) | Sagar Savale
6/19/2016 Sagar Kishor Savale
2. Introduction
Definition : The NDA application is the vehicle through which drug sponsors,
such as biotech and pharmaceutical companies, formally propose that the FDA
approve a new pharmaceutical for sale and marketing.
For decades, the regulation and control of new drugs in the United States has
been based on the New Drug Application (NDA).
26/19/2016 Sagar Kishor Savale
3. Since 1938, every new drug or therapy has been the subject of an approved NDA
before US commercialization.
The documentation required in an NDA is supposed to tell the drug's whole story,
including what happened during the clinical tests, what the ingredients of the drug
are, the results of the animal studies, how the drug behaves in the body, and how
it is manufactured, processed and packaged.
36/19/2016 Sagar Kishor Savale
4. Definitions
Drug: Drug are the substance intended to be used for or in the diagnosis,
treatment, mitigation, or prevention of any disease or disorder in human being or
animal.
New drug: Drug that has not been declared safe and effective by qualified expert
under the condition prescribed, recommended, or suggested in the and that may
be new chemical formula or an established drug prescribed for use in new way.
46/19/2016 Sagar Kishor Savale
5. 5
Drug
All medicines for internal or external use of human beings or animals or
All substances intended to be used for or in the diagnosis, treatment mitigation or
prevention of any disease or disorder in human and animal.
Such substances (other than food) intended to affect the structure or any function of human
body.
All substances intended for use as components of a drug including empty gelatin capsules.
Such devices intended for internal or external use in the diagnosis, treatment, mitigation or
prevention of disease or disorder.
6/19/2016 Sagar Kishor Savale
6. 6
New drug
A new substance of chemical, biological, or biotechnological origin in bulk or
prepared dosage form used for diagnosis, treatment, mitigation or prevention of
any disease or disorder in human or animal which except during local clinical trial
has not been used in the country to any significant extent and during local clinical
trials has not been recognized in the country as effective and safe for the proposed
claims.
6/19/2016 Sagar Kishor Savale
7. 7
New Drug Application (NDA)
An application submitted by the manufacturer of a drug to the FDA - after clinical trials have
been completed - for a license to market the drug for a specified.
New Drug Application (NDA) is the vehicle in the United States through which drug sponsors
formally propose that the FDA approve a new.
Abbreviated New Drug Application (ANDA)
An application for a license to market a generic (or a duplicate) version of a drug that
has already been granted an approval under a full NDA (i.e. the drug has already met
the statutory standards for safety and effectiveness.
6/19/2016 Sagar Kishor Savale
8. OBJECTIVE OF NDA
Whether the drug's proposed labeling (package insert) is appropriate, and what it
should contain.
Whether the drug is safe and effective in its propose use, and whether the benefits
of the drug outweigh the risks .
Whether the methods used in manufacturing the drug and the controls used to
maintain the drug's quality are adequate to preserve the drug's identity, strength,
quality, and purity.
86/19/2016 Sagar Kishor Savale
9. NDA FORM
Form FDA-356h. Application to market a new drug, biological or an antibiotic drug for
human use.
Form FDA 3397. User fee cover sheet.
Form FDA 3331. New drug application field report.
Impurity in drug substances.
Required specification for FDAs IND, and ANDA drug master file binders.
Refusal to file.
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12. 12
Introduction of NDA and ANDA
NDA and ANDA is application is send to FDA for approval of new drug and abbreviated (
generic) new drug.
When new drug application is submitted to food and drug administration it must be carefully
prepared , comprehensive , readable and well indexed.
The guideline issued by FDA has to follow Should follow D & C Act.
Code of federal regulation title 21 section 314 ( 21 CFR 314) is provided a brief description
for NDA and ANDA
Experience : It is generally planned 3 years ago.
6/19/2016 Sagar Kishor Savale
13. 13
Requirement
Requirement for NDA
Format requirement
A) No of copies - Before 1985- 3 copies & now only 2 copies.
Archival copy
Review copy
1) Archival copy
- Reference copy for FDA ( i.e. retained by FDA )
- Locate information not contained in review copy
2) Review copy
- Divided in to five or six section containing technical
and scientific information separately bound
- It contains copy of cover letter, application form,
overall summary, index, specific review section
6/19/2016 Sagar Kishor Savale
14. 14
B) Assembling the application
1) Folder
- Color folder
Eg. archival copy - blue
chemistry section – red
- Name of applicant and name of drug product
- NDA no. if known
2) Paper size and binding
- Page 8.5 – 11 inches
- Bound at left side
- Use both side
- Accurately no.
3) Pagination – page no of both copy should have same
6/19/2016 Sagar Kishor Savale
15. 15
4) Volume size and identification
- Not more than 2 inches thick
- Should have name of applicant, drug and
- NDA no.
5) Packing carton
- Box size 14 -12- 9.5 inches
6/19/2016 Sagar Kishor Savale
16. 16
Basic requirements
Archival copy contains
- Application form (FDA 356th) It contains
- basic identification information
- as per form items no. 1 and 2 should bound together
- 3 to 12 submitted separately
- 13 and 14 separately
- Index -
6/19/2016 Sagar Kishor Savale
17. 17
Summary requirement
1) Labeling : -Proposed label
- It is also called mini summary
2) Pharmacological class
Intended use
Potential clinical benefit
3) Foreign marketing history
- List of country who approved same drug
- List of country who withdrawn same drug
6/19/2016 Sagar Kishor Savale
18. 18
4) Chemistry, mfg., control
A) Drug substance
Names:- name, synonym, code designation, brand name, identification no. and
chemical name.
Physical and chemical properties: MP, BP, mol wt., solubility, mol. Formula structural
formula, PH, isomer, polymorphs.
Stability
Manufacture- Name and method.
6/19/2016 Sagar Kishor Savale
19. 19
B) Drug product
a) Composition
b) Dosage form
c) Manufacture
d) Specification
e) Analytical method
f) Container
g) Closure
h) Stability
i) Investigational formulation
6/19/2016 Sagar Kishor Savale
20. 20
5) Nonclinical pharmacology and toxicology summary
A) Pharmacological studies
B) Acute toxicity studies
C) Multi dose toxicity studies
D) Mutagenicity studies
E) Reproduction studies
F) ADME studies
6) Human pharmacokinetic summary
7) Microbial summary
- Microbial spectra
- Mechanism of action
6/19/2016 Sagar Kishor Savale
21. 21
8) Clinical data summary and result
A) Clinical pharmacology
B) Overview of clinical studies
C) Controlled clinical studies
D) Uncontrolled clinical studies
E) Other studies and information
F) Safety summary
a) Extent of exposure
b) Adverse event
c) Clinical laboratory data
e) Over dose
f) drug abuse
6/19/2016 Sagar Kishor Savale
22. Guidance Documents for NDA
Submitting documentation for the stability of human drugs and biologics.
Format and content of human pharmacokinetics and bioavailability section of an
application.
Providing clinical evidence of effectiveness for human drug and biological product.
226/19/2016 Sagar Kishor Savale
23. 23
9) Discussion of benefit to risk relationship and proposed post marketing studies.
10) Bioavailability summary
NDA technical section requirement
1) Chemistry, manufacturing, and control
A) Drug substance
B) Product
2) Non clinical pharmacology and toxicology
3) Human pharmacokinetics
4) Bioavailability section
6/19/2016 Sagar Kishor Savale
24. 24
5) Microbiology
A) Mechanism of action
B) Pharmacokinetics
C) Antimicrobial activity
D) Enzyme hydrolysis rate
E) Assessment of resistance
F) In vivo animal studies
G) In vitro studies during clinical trial
H) Published literature
I) Miscellaneous studies
6/19/2016 Sagar Kishor Savale
25. 25
6) Clinical data section
- adverse dose- response information
- drug -drug interaction
- drug disease interaction
Other NDA requirement
A) Safety updates
B) Sample : 4 samples
C) Method validation
D) Label : Draft labeling -4 copies
Final print labeling -12 copies
E) Case report
6/19/2016 Sagar Kishor Savale
26. 26
NDA and ANDA Requirements
Brand Name Drug Generic Drug
NDA Requirements ANDA Requirements
1. Chemistry 1. Chemistry
2. Manufacturing 2. Manufacturing
3. Controls 3. Controls
4. Labeling 4. Labeling
5. Testing 5. Testing
6. Animal Studies
7. Clinical Studies 6. Bioequivalence
8. Bioavailability
6/19/2016 Sagar Kishor Savale
27. 27
NDA Classifications
1. New Molecular Entity
2. New Salt of Previously Approved Drug (not a new molecular entity)
3. New Formulation of Previously Approved Drug (not a new salt OR a new
molecular entity)
4. New Combination of Two or More Drugs
5. Already Marketed Drug Product - Duplication (i.e., new manufacturer)
6. New Indication (claim) for Already Marketed Drug (includes switching
marketing status from prescription to OTC)
7. Already Marketed Drug Product - No Previously Approved NDA
6/19/2016 Sagar Kishor Savale
28. Specification for FDAs DMF binders
• Polyethylene binder:
Front- 248× 292 mm
Back- 248× 305 mm
Ink Colour must be BLACK
286/19/2016 Sagar Kishor Savale
29. • Paper binder
Front 267×292mm
Back 267× 305mm
Ink must be BLACK , Marron Colour binder ink must be WHITE
296/19/2016 Sagar Kishor Savale
30. FORM COLOUR DOCUMENT
FDA form 2226 Blue NDA archival binder
FDA form 2675 Red IND archival binder
FDA form 3316 Red Drug master file binder
FDA form 3316a Blue Drug master file binder
archival binder
306/19/2016 Sagar Kishor Savale
31. FORM COLOUR DOCUMENT
FDA Form 2626a Red NDA chemistry binder
FDA Form 2626b Yellow NDA pharmacology binder
FDA Form 2626c Orange NDA pharmacokinetic binder
FDA Form 2626d White NDA microbiology binder
FDA Form 2626e Tan NDA clinical data binder
FDA Form 2626f Green NDA statistics binder
FDA Form 2626h Marron NDA field submission chemistry
binder
FDA Form 2675a Green IND chemistry binder
316/19/2016 Sagar Kishor Savale
33. Archival copy
Reference copy for FDA ( i.e. retained by FDA ) .
Locate information not contained in review copy.
It must bound in blue cover
Review copy
Divided in to five or six section containing technical and scientific information separately
bound.
It contains copy of cover letter, application form, overall summary, index, specific review
section.
336/19/2016 Sagar Kishor Savale
34. NDA Contents
• The NDA have as many as 15 different section in addition to the Form FDA 356h
itself.
• The specific content of NDA will depend on the nature of the drug product and
the information available at the time of submission the application.
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35. NDA content
35
section 1
Section 2
Section 3
Section 4
Chemistry , manufacturing and control
Section 5 Nonclinical pharmacology and toxicology
Index
summary
Sample and labeling
6/19/2016 Sagar Kishor Savale
36. NDA Contents
36
Section 6
Section 7
Section 8
Section 9
Section 10
Human pharmacokinetics and bioavailability
Clinical microbiology
Clinical data
Safety update report
statistics
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37. NDA Contents
37
Section 11
Section 13
Section 12
Section 14
Case report tabulation
Case report form
Patent information
Patent certification
Section 15 other
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THE TWO TRANSLATIONAL BLOCKS
Basic
Biomedical
Research
Clinical
Science
and
Knowledge
Goal:
Improved
Health
Translation from
basic science to
human studies
Translation of
new knowledge
into clinical practice
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NDA review
Usually six different teams responsible for reviewing NDA includes
1. Chemistry
2. Clinical
3. Pharmacology/ toxicology
4. Statistics
5. Biopharmaceutical
6. Microbiology
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New Drug Development and Review Process
Steps from Test Tube to New Drug Application Review
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Phases of clinical testing
Phase Number of
patients
Length Purpose Percent
successfully
completing
Phase 1 20-100 Several months Mainly safety
67
Phase 2 Up to several
hundred
Several months
to two years
Some short-
term safety but
mainly
effectiveness
45
Phase 3 Several hundred
to several
thousand
1-4 years Safety,
effectiveness,
dosage
5-10
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46. Fast track approval
Drug for
Serious disease.
Fill an unmet need.
Must be requested by the drug company .
FDA 60 days review decision.
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47. Accelerated approval
In 1992 FDA instituted the accelerated approval regulation.
Based on surrogate endpoint, not on clinical outcome.
A surrogate endpoint is a marker- a laboratory measurement, or physical sign
that is used in clinical trial as an indirect or substitute measurement that
represent a clinically meaningful outcome, such as survival or symptom
improvement.
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48. Priority review
A priority review designation is given to drug that offer major advances in
treatment.
The goal for completing a priority review is 6 month.
It can given for drug used in serious/non serious disease.
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The NDA in CTD Format
Module 1 is not part of the CTD because it is not harmonized
CTD NDA: 314.50
Module 1 a) Application form
c)2.1 Annotated text of
proposed labeling
e)Samples and Labeling
h)Patent information
i) Patent certification
j)Claimed exclusivity
Module 2 c)Summaries
d)5.7 Abuse potential
Module 3 d)1 CMC
Module 4 d)2 Nonclinical pharm/tox
Module d)3 Human PK
d)4 Microbiology
d)5 Clinical data
d)6 Statistical section
f) CRF and CRT 526/19/2016 Sagar Kishor Savale
53. Difference between NDA & ANDA
NDA ANDA
Applicable for new drug Applicable for generic drug
Money requirement is high Less money compare to NDA
12 to 15 year required 1 to 2 year required
Cost of drug is high Cost of drug is less
Non clinical and clinical study are essential. Bioavailability and bioequivalence study
essential
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