Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Assignment on Regulatory Prespectives of Clinical TrialsDeepak Kumar
Assignment on Origin and Principles of International Conference on Harmonization - Good Clinical Practice, (ICH-GCP) guidelines Ethical Committee- Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
It contains following subheadings:
-maxilla and mandible anatomy
-TMJ(Temporo mandibular joint)
-Muscles of mastication
By:
Dr. Syed Irfan Qadeer
Prof. and HOD Department of Anatomy
SPIDMS,Lucknow
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
- 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
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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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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.
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.
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.
2. • Directorate General of Health Services
Ministry of Health and Family
Welfare
• Drugs Controller General of India.
CDSCO-Central Drugs Standard
Control Organization
Retail and
Distribution
Manufacturing
Practice
Clinical Trials and
new drug
development
DRUG REGULATION IN INDIA
3. • 1. Schedule X – Narcotics
2. Schedule H – Prescription drugs
3. Schedule C and C1- Biological Products (Serums and
Vaccines)
Retail and Distribution
• 1. Schedule N
List of the equipment for the efficient running of manufacturing
wing, Qualified personnel
2. Schedule M-GMP
Manufacturing Practice
• Schedule Y
Clinical Trials and new drug development
4. The drugs and cosmetics act and
rules:
• GOVERNMENT OF INDIA MINISTRY OF
HEALTH AND FAMILY WELFARE Introduced
THE DRUGS AND COSMETICS ACT (1940)
AND RULES (1945)
An Act to regulate the import, manufacture, distribution
and sale of drugs and cosmetics in India.
6. • 122-A Application for permission to import
new drug.
• 122-B Application for approval to manufacture
new drug.
• 122-D Permission to import or manufacture
FDC.
7. 1. APPLICATION FOR PERMISSION:
Application for permission to import or manufacture new
drugs along with following data:
Introduction
Chemical and pharmaceutical information
Animal Pharmacology
Animal toxicology
Human / Clinical pharmacology (Phase I)
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special studies
Regulatory status in other countries
Prescribing information
8. Chemical and pharmaceutical information
• Information on active ingredients
• Drug information (Generic Name, Chemical Name)
• Physical and chemical properties of drug
• Analytical Data
• Complete monograph specification including
• Validations
• Stability Studies
• Data on Formulation
• Dosage form
• Composition
• Excipient compatibility study
9. Animal Pharmacology
• Summary
• Specific pharmacological actions
• General pharmacological actions
• Follow-up and Supplemental Safety Pharmacology
Studies
• Pharmacokinetics: absorption, distribution;
metabolism; excretion
10. SPECIFIC PHARMACOLOGICAL ACTONS
• Actions which demonstrate the therapeutic
potential for humans.
• Scientifically validated methods should be used.
GENERAL PHARMACOLOGICAL
ACTIONS
• Safety pharmacology studies
• Effects on different organs
11. Animal toxicology
• Systemic Toxicity studies
• Single dose toxicity studies
• Repeated dose toxicity studies
• Male fertility studies
• Female Reproduction and Developmental Toxicity
Studies
• Local toxicity
• Allergy/Hypersensitivity
• Genotoxicity
• Carcinogenicity
12. Single dose toxicity
• Four graded doses should be given.
• Each group should contain at least 5 animals of either
sex.
• At least Animals should be exposed to the test
substance in a single bolus or by continuous infusion
or several doses within 24 hours.
• Animals should be observed for 14 days
• Minimal lethal dose(LDmin)
• Maximum tolerated dose
13. Dose-ranging Study
• MTD is established from the single dose toxicity
study
• Study is performed in one rodent and one non
rodent species.
• 5 animals in each group and at least 4 graded doses
should be given
• It is given consequently for 10 days
• Organ specific toxicity is established.
14. Male Fertility Study
• Six animals are taken in each group
• Animals should be treated with the test substance by
the intended route of clinical use for minimum 28 days
and maximum 70 days
• They are paired with female animals of proven fertility
in a ratio of 1:2 for mating for at least 10 days.
• Females getting thus pregnant should be examined for
their fertility after day 13 of gestation.
All the male animals should be sacrificed at the end of
the study and organs of reproduction are examined
15. Female Reproductive Studies
• These studies need to be carried out for all drugs
proposed to be studied or used in women of child
bearing age
• These are done under 3 segments:
SEGMENT I Albino mice or rat Female Fertility Study
SEGMENT II Albino mice or rat Teratogenicity Study
SEGMENT III Albino mice or rat
+
Albino rabbits
Perinatal Study
16. Local toxicity
These studies are required when the new drug is
proposed to be used by some special route (other than
oral) in humans:
It includes:
• Dermal toxicity
• Vaginal toxicity
• Rectal toxicity
• Parenteral toxicity: injection site toxicity
• Ocular and inhalational toxicity studies
17. Genotoxicity and Carcinogenicity
It is required for a drug that is intended to be used for
a chronic illness or a drug that is used for a long period
of time(>6 months)
Genotoxicity data are not required before Phase I and II
trials. But these studies should be completed before
applying for Phase III trials.
18. • 122-DA Permission to conduct clinical trials for
new drug / investigational new drug.
• 122 - DAA Definition of CLINICAL TRIAL.
• 122- DAB Reports of Serious Adverse Events
(SAEs) including deaths.
• 122- E New Drug
19. Clinical Trial
“Clinical trial” means a systematic study of new drug(s) in
human subject(s) to generate data for discovering and/or
verifying the clinical, pharmacological (including
pharmacodynamic and pharmacokinetic) and/or adverse
effects with the objective of determining safety and / or
efficacy of the new drug.”
122 - DAA
20. New Drug
A new substance of chemical, biological or biotechnological
origin, in bulk or prepared dosage form; used for prevention,
diagnosis, or treatment of disease in man or animal; which
except during local clinical, trials, has not been used in the
country to any significant extent and which except during
local clinical trials, has not been recognised in the country
as effective and safe for the proposed claims.
122-E
21.
22. Post Marketing Trials (Phase IV)
Subsequent to approval of the product, new drugs
should be closely monitored for their clinical safety once
they are marketed.
The report is to be submitted every six months for the
first two years after approval of the drug is granted to
the applicant. For subsequent two years need to be
submitted annually and may be extended if necessary.
It is done to detect unexpected adverse effects and drug
interactions.
23. DRUG DISCOVERED
IN INDIA
DRUG DISCOVERED
OUTSIDE INDIA
STARTED FROM
PHASE I
PHASE II TRIAL
PHASE II TRIAL
PREVIOUS PHASE I
DATA
APPROVED
24. 2. CLINICAL TRIAL
PERMISSION
Licensing AuthorityThe ethics committee.
INVESTIGATORSPONSER
• Quality assurance
• Submission of status report.
• Reporting of any serious
adverse effect
• To ensure that laboratories
used for generating data for
clinical trials should be
compliant with Good
Laboratory Practices
• Conduct of the trial
according to the protocol
and the GCP Guidelines
• Follow the SOP’s.
• Ensure that adequate
medical care is provided
to the participant for any
adverse events.
25. Serious Adverse Events
• Any undesirable experience associated with the use of
a medical product in a patient
• It should be reported within 14 days by the Sponsor to
the Licensing Authority and to the other
Investigator(s) participating in the study
Death Life-threatening
Hospitalization Disability or Permanent Damage
Congenital Anomaly/Birth Defect Required Intervention to Prevent
Permanent Impairment or Damage
(Devices)
Other Serious (Important Medical
Events)
122- DAB
26. The Drugs and Cosmetics Rule made an amendment
GSR 53(E) dated 30-01- 2013 inserting a Rule 122DAB
and a new Appendix-XII in Schedule Y
It determine the quantum of compensation, if any, to be
paid by the Sponsor or his representative, whosoever
have obtained permission from the Drugs Controller
General(India) in a time bound manner.
B = Base amount (i.e. 8 lacs)
F = Factor depending on the age of the
subject (based on Workmen
Compensation Act)
R = Risk Factor
28. RISK FACTOR INDEX(R) RISK FACTORS
0.50 terminally ill patient (expected
survival not more than (NMT)
6 months)
1.0 Patient with high risk
(expected survival between 6
to 24 months)
2.0 Patient with moderate risk
3.0 Patient with mild risk
4.0 Healthy Volunteers or subject
of no risk
29.
30.
31. • 122 – DD Registration of Ethics Committee (EC).
32. ETHICS COMMITTEE
It is the responsibility of the ethics committees that reviews and
accords its approval to a trial protocol to safeguard the rights, safety
and well being of all trial subjects.
• Care of the vulnerable group in the study: patients with
incurable diseases, unemployed or impoverished
persons, patients in emergency situation, others
incapable of personally giving consent
• Ethics Committee(s) should make, at appropriate
intervals, an ongoing review of the trials for which they
review the protocol
122 – DD
33. • The number of persons in an Ethics Committee
should have at least seven members
Chairperson
outside the institution
Member Secretary
(a)basic medical scientists (preferably one
pharmacologist).
(b) clinicians
(c) legal expert
(d) social scientist/ representation of non-
governmental voluntary agency /
philosopher / ethicist / theologian or similar
person
(e) lay person from the community
34. INFORMED CONSENT
In all clinical trials freely given, informed written consent
is required to be obtained from each study subject
• Verbal information of the study using a patient
information sheet
• Language that is nontechnical and understandable by
the study subject.
• Where a subject is not able to give informed consent,
the same may be obtained from a legally acceptable
representative.
35. STUDIES IN SPECIAL POPULATION
• Geriatrics:
• Geriatric patients should only if the disease intended to
be treated is characteristically a disease of aging
• The conditions to be treated should be common in the
elderly are likely to be encountered
• When the new drug is likely to alter the geriatric
patient’s response compared with that of the non-
geriatric patient.
36. • Pregnant or nursing women:
Pregnant or nursing women should be included in
clinical trials only when the drug is intended for use
by pregnant/nursing women or foetuses/nursing
infants and where the data generated from women
who are not pregnant or nursing, is not suitable.
37. Paediatrics:
• When clinical development is to include studies in
children, it is usually appropriate to begin with older
children before extending the trial to younger children
and then infants.
• Initial safety and tolerability data should be obtained
from the adult population data before starting trial in
children.
• Written informed consent should be taken from the
legal guardians.