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.
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
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
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.
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
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Antimicrobial sensitivity testing (AST) or Antibiotic Sensitivity Testing.
Contents:
1. Need of AST
2. Bacterial Resistance
3. Preperation of test: selection of antibiotic and bacteria
4. Types of tests
5. Process of tests
Interaction between drug API and various excipients used in formulation.Different methods of Interaction between them.Mechanism of interaction between them. Excipient Compatibility Studies. Analytical Techniques for Drug Excipents Compatibility Studies.
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
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
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.
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
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.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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.
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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!
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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Regulatory Requirements for Drug Product Approval
1. Presented By:
Atul Adhikari
M. Pharm(Pharmaceutics) 1st sem,
Assam downtown university, Assam.
Guided By:
Satyendra Deka
Department of Pharmacy,
ADTU
2. WHY???
Thalidomide catastrophe (1962)
Phocomelia(malformation of limbs)
10,000 cases reported worldwide, 50% survived
Elixir sulphonamide(1937)
Diethylene glycol known toxin was used as solvent
More than 100 death
Such tragic incidents led to introduction of regulations for approval of new drugs
2ADTU, Guwahati
3. INTRODUCTION
The new drug approval is of two phase process –
the first phase for clinical trials and second phase for marketing authorization of drug.
Firstly, non-clinical studies of a drug are completed to ensure efficacy and safety, and
then application for conduct of clinical trials is submitted to the competent authority of
the concerned country. Thereafter, the clinical trials can be conducted (phase I to phase
IV).
These studies are performed to ensure the efficacy, safety and optimizing the dose of
drug in human beings.
After the completion of clinical studies of the drug, then an application to the competent
authority of the concerned country for the approval of drug for marketing is submitted.
The competent authority review the application and approve the drug for marketing only
if the drug is found to be safe and effective in human being or the drug have more
desirable effect as compare to the adverse effect .
3ADTU, Guwahati
4. Even after the approval of new drug, government should monitor its safety
due to appearance of some side effects, when it is used in larger
population. The interactions with other drugs, which were not assessed in a
pre-marketing research trial and its adverse effects
4ADTU, Guwahati
5. REGULATORY
ORGANIZATIONS IN
COUNTRIES USFDA(Unites States)
CDSCO- Central drugs standard control organization ( India)
EMEA- European Agency for the evaluation of medicinal products (
( European Union)
MoH(Sri Lanka)
DDA- Department of drug Administration (Nepal)
5ADTU, Guwahati
6. DRUG APPROVAL PROCESS IN USA
In 1820, the new era of USA drug regulation was started with the establishment of US
Pharmacopoeia. In 1906, Congress passed the original Food and Drugs Act, which
require that drugs must meet official standards of strength and purity. However, in 1937,
due to sulphanilamide tragedy, the Federal Food, Drug and Cosmetic Act (of 1938) was
enacted and added new provisions that new drugs must be shown safe before
marketing.
6ADTU, Guwahati
7. DIFFERENT TYPES OF DRUG
APPLICATIONS THAT CAN BE
SUBMITTED TO FDA
IND(investigational new drug application)
NDA(new drug application)
ANDA( abbreviated new drug application)
BLA(biologic license Application)
7ADTU, Guwahati
8. The Food and Drug Administration (FDA) is responsible for protecting and promoting
public health.
FDA’s new drug approval process is also accomplished in two phases: clinical trials
(CT) and new drug application (NDA) approval. FDA approval process begins only
after submission of investigational new drug (IND) application.
The IND application should provide high quality preclinical data to justify the testing of
the drug in humans. Almost 85% of drugs are subjected to clinical trials, for which IND
applications are filed.
8ADTU, Guwahati
10. A new drug application (NDA) can be filed only when the drug successfully passes all
three phases of clinical trials and includes all animal and human data, data analyses,
pharmacokinetics of drug and its manufacturing and proposed labelling.
The preclinical, clinical reports and risk-benefit analysis are reviewed at the Center for
Drug Evaluation and Research by a team of scientists. Generally approval of an NDA
is granted within two years (on an average), however, this process can be completed
from two months to several years.
The innovating company is allowed to market the drug after the approval of an NDA
and is considered to be in Phase IV trials. In this phase, new areas, uses or new
populations, long-term effects, and how participants respond to different dosages are
explored.
10ADTU, Guwahati
15. DRUG APPROVAL PROCESS
IN INDIA
The regulatory scenario in India is changing very fast and DCGI is coming up with
precise guideline on each topic. The documentation for product registration in India
has become at par with US FDA and seems to objective of DCGI so that data
generated in India is acceptable globally.
15ADTU, Guwahati
16. HISTORY OF DRUG
REGULATION IN INDIA
Back to British rule when the majority of drugs were imported.
The Indian Council of Medical Research (ICMR) was created in 1949 to guide and
manage medical research.
The first Drugs and Cosmetics Act came into effect in 1940 and was later amended as the
Drugs and Cosmetics Rules of 1945. The 1945 amendment established the CDSCO and
the DCGI.
A specific sub-Drugs and Cosmetics Act was developed, called Schedule Y, to regulate
clinical research conduct.
The Department of Biotechnology was created in 1986 to facilitate various aspects of
biotechnology.
ICMR issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000,
and the CDSCO released the Indian Good Clinical Practice Guidelines in 2001. Together,
these agencies assist the licensing authority in issuing final marketing approvals for
products.
16ADTU, Guwahati
19. At the central level, DCGI, under the Ministry of Health and Family Welfare, approves
the drug or medical device for marketing. Manufacturing licenses are approved at the
state level by state drug control authorities. Monitoring is also performed by state
agencies in coordination with the CDSCO.
Manufacturing, importing, or conducting a clinical trial requires permission from the
licensing authority through a Form 44 application. The application follows international
submission requirements of a Common Technical Document (CTD) and has five
modules.
19ADTU, Guwahati
21. Form 44 requires information as described in Schedule Y of the Drugs and Cosmetics
Act.
The clinical trial must be conducted in accordance with ethical principles.
The Act has a special provision (Rule 122-A) to accept international trial data or other
information, to allow import, and to waive the clinical trial requirement in the interest of
public health. A clinical trial may also be waived for drugs that are approved and have
been used in other countries for many years.
21ADTU, Guwahati
22. SCHEDULE Y
• Requirements and guidelines to import and/or manufacture of new drug for sale or to
undertake clinical trials
• It has outlined extensive study criteria in line with the globally accepted formats such
as ICH and US FDA guidelines
• It can be referred to rules 122A, 122B, 122D, 122DA, 122DAA and 122E.
22ADTU, Guwahati
23. PURPOSE OF SCHEDULE Y
To frame guidelines to conduct clinical research
Control and regulation for new drugs.
CDSCO formulated GCP under schedule Y in 2005
23ADTU, Guwahati
24. Fig: Flowchart of regulatory requirements for New Drug Application(NDA) in India
24ADTU, Guwahati
26. PRINCIPLE DIFFERENCES
BETWEEN US AND INDIA
requirements US India
Agency USFDA DCGI
Application ANDA/NDA MAA
Debarment yes no
Approval Time ≈18 months ≈12-18 months
fees Under $2
millions- NDA
$51,520-ANDA
Application
50,000 INR
26ADTU, Guwahati