Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Chronopharmacology is the branch of science which deals with the pharmacological action of a drug in relation to biological rhythm.
(Chronos: time; Pharmacon: drug; Logos: study)
It is concerned with the effects of drugs upon the timing of biological events and rhythms.
It is important to enhance the therapeutic efficacy, optimization of drug effects, minimization of adverse effects by using timing medications in relation to biological rhythm.
History:
Jean-Jaques d’Ortous de Mairan: Described circardian rhythm in plants in the 18th century.
Franz Halberg : coined the term ‘Circardian’ in 20th century (about 24 hr or about a day)
Franz Halberg : Founder of Chronobiology.
Biological Rhythm:
Biological rhythm: It is the determined rhythmic biological process or function within a defined time period.
TYPES OF RHYTHM
Circadian (last for 24 hr) – Sleep wake cycle
Infradian (> 24 hr) – Menstrual cycle
Ultradian (< 24 hr) – Neuronal firing time
Biological Clock:
An internal biological clock located in mammals, in the suprachiasmatic nucleus of the hypothalamus (SCN), delivering its message of time throughout the body.
It is responsible for circadian rhythms and annual/seasonal rhythm.
The SCN uses its connections with the autonomic nervous system for spreading its time-of-day message, either by setting the sensitivity of endocrine glands (thyroid, adrenal, ovary) or by directly controlling an endocrine output of pineal gland (i.e. melatonin synthesis)
Application:
Chronotherapy found useful in
Asthma therapy, Strokes, Sleep disorders, GI tract disorders, Allergies, Oncology etc
Recent Advances:
Casein Kinase 1 (CK-1) inhibitor: Potential new drug
Reset the circadian clock enzymes.
Uses: Jet lag, sleep disorder, bipolar disorder
Animal trials completed.
Clinical trials are awaited.
Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Introduction
Regulatory Requirements
Key function of regulatory agencies
Regulation in India
DRUG TECHNICAL ADVISORY BOARD
Drugs Consultative committee-DCC
Schedule Z of Drugs & Cosmetics Act for ASU drugs.
Chronopharmacology is the branch of science which deals with the pharmacological action of a drug in relation to biological rhythm.
(Chronos: time; Pharmacon: drug; Logos: study)
It is concerned with the effects of drugs upon the timing of biological events and rhythms.
It is important to enhance the therapeutic efficacy, optimization of drug effects, minimization of adverse effects by using timing medications in relation to biological rhythm.
History:
Jean-Jaques d’Ortous de Mairan: Described circardian rhythm in plants in the 18th century.
Franz Halberg : coined the term ‘Circardian’ in 20th century (about 24 hr or about a day)
Franz Halberg : Founder of Chronobiology.
Biological Rhythm:
Biological rhythm: It is the determined rhythmic biological process or function within a defined time period.
TYPES OF RHYTHM
Circadian (last for 24 hr) – Sleep wake cycle
Infradian (> 24 hr) – Menstrual cycle
Ultradian (< 24 hr) – Neuronal firing time
Biological Clock:
An internal biological clock located in mammals, in the suprachiasmatic nucleus of the hypothalamus (SCN), delivering its message of time throughout the body.
It is responsible for circadian rhythms and annual/seasonal rhythm.
The SCN uses its connections with the autonomic nervous system for spreading its time-of-day message, either by setting the sensitivity of endocrine glands (thyroid, adrenal, ovary) or by directly controlling an endocrine output of pineal gland (i.e. melatonin synthesis)
Application:
Chronotherapy found useful in
Asthma therapy, Strokes, Sleep disorders, GI tract disorders, Allergies, Oncology etc
Recent Advances:
Casein Kinase 1 (CK-1) inhibitor: Potential new drug
Reset the circadian clock enzymes.
Uses: Jet lag, sleep disorder, bipolar disorder
Animal trials completed.
Clinical trials are awaited.
unit 1 herbal drug technology handwriting notes part 1.pdfMOHITROCK1
unit 1 herbal drug technology handwriting notes b pharm 6th semester
B pharm 6th semester
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material
subscribe the channel :Work&Life Hobbies
watch video:https://www.youtube.com/watch?v=v3rI1lf2TZ8&t=403s
This slide describes the Important Synthesis of Antiviral Drugs
Appetite Stimulant And Suppressants.pptxGokul546572
# Definition of Appetite
# What causes a decrease in appetite
# Definition of Appetite Stimulants
# Classification of Appetite Stimulants
# Zinc
# Mechanism of action Zinc
# Thiamine
# Dronabinol
# Mechanism of action Dronabinol
# Use & Side effects of Dronabinol
# Oxandrolone
# Mechanism of action of Oxandrolone
# Use & Side effects of Oxandrolone
# Definition of Appetite Suppressants
# Classification of Appetite Suppressants
# Mechanism of action of Centrally Acting Drugs
# Side effects and other effects of Centrally acting drugs
# Definition of Serotonergic agents
# Fenfluramine
# Definition of Adrenergic Serotonergic agents
# Sibutramine
The details about the elimination of the drug from the body by various methods. drug metabolism, drug transformation, drug elimination process. factors affecting.
UNIT-1 Introduction to biotechnology and enzyme immobilisation Brief introduc...Shyam Bass
(6th Sem B.Pharma Pharmaceutical Biotechnology)
UNIT-1 Introduction to biotechnology and enzyme immobilization Brief introduction to biotechnology, Enzyme biotechnology- methods of enzyme immobilization and applications, biosensors- working and applications of biosensors in pharmaceutical industries
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
unit 1 herbal drug technology handwriting notes part 1.pdfMOHITROCK1
unit 1 herbal drug technology handwriting notes b pharm 6th semester
B pharm 6th semester
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material
subscribe the channel :Work&Life Hobbies
watch video:https://www.youtube.com/watch?v=v3rI1lf2TZ8&t=403s
This slide describes the Important Synthesis of Antiviral Drugs
Appetite Stimulant And Suppressants.pptxGokul546572
# Definition of Appetite
# What causes a decrease in appetite
# Definition of Appetite Stimulants
# Classification of Appetite Stimulants
# Zinc
# Mechanism of action Zinc
# Thiamine
# Dronabinol
# Mechanism of action Dronabinol
# Use & Side effects of Dronabinol
# Oxandrolone
# Mechanism of action of Oxandrolone
# Use & Side effects of Oxandrolone
# Definition of Appetite Suppressants
# Classification of Appetite Suppressants
# Mechanism of action of Centrally Acting Drugs
# Side effects and other effects of Centrally acting drugs
# Definition of Serotonergic agents
# Fenfluramine
# Definition of Adrenergic Serotonergic agents
# Sibutramine
The details about the elimination of the drug from the body by various methods. drug metabolism, drug transformation, drug elimination process. factors affecting.
UNIT-1 Introduction to biotechnology and enzyme immobilisation Brief introduc...Shyam Bass
(6th Sem B.Pharma Pharmaceutical Biotechnology)
UNIT-1 Introduction to biotechnology and enzyme immobilization Brief introduction to biotechnology, Enzyme biotechnology- methods of enzyme immobilization and applications, biosensors- working and applications of biosensors in pharmaceutical industries
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Spinal and peripheral nerve poisons quick reviewPriyanka Mishra
Its a quick revision on Spinal & Peripheral Nerve poisoning for Exam point of view!
The slides are made in such a way that you can answer questions in exams easily
What is definition of poisoning?
Poisoning is injury or death due to swallowing, inhaling, touching or injecting various drugs, chemicals, venoms or gases. Many substances — such as drugs and carbon monoxide — are poisonous only in higher concentrations or dosages.
activated charcoal – sometimes used to treat someone who's been poisoned; the charcoal binds to the poison and stops it being further absorbed into the blood.
antidotes – these are substances that either prevent the poison from working or reverse its effects.
There are four major routes by which a chemical may enter the body:
Inhalation (breathing)
Skin (or eye) contact.
Swallowing (ingestion or eating)
Injection.
The presentation describes the various types of Narcotic substances and different pathological conditions which occur due to their consumption in drug abusers.
These are the pharmacological agent which when administered externally relieves mild or moderate pains without degree of consciousness called as Analgesics are worked against the pain so firstly introduced the Pain sensation.
Skin sensitisation, OECD Test guideline 406 .pptxNikitaBankoti2
Skin Sensitisation: ( allergic contact dermatitis) is an immunologically mediated cutaneous reaction to a substance. In the human, the responses may be characterised by pruritis, erythema, oedema, papules, vesicles or a combination of these. In other species the reactions may differ and only erythema and oedema may be seen.
Role Of Transgenic Animal In Target Validation-1.pptxNikitaBankoti2
A Transgenic animal is one that carries a foreign gene that has been deliberately inserted into its genome.
The foreign gene are inserted into the germ line of the animal, so it can be transmitted to the progeny.
Transgenic animals are animals that are genetically altered to have traits that mimic symptoms of specific human pathologies.
They provide genetic model of various human disease which are important in understanding disease and development of new target.
The identification of the carcinogenic properties of a chemical, resulting in an increased incidence of neoplasms, increased proportion of malignant neoplasms or a reduction in the time to appearance of neoplasms, compared with concurrent control groups.
The identification of target organ(s) of carcinogenicity.
The identification of the time to appearance of neoplasms.
Characterisation of the tumour dose-response relationship.
Real-time PCR is a technique used to monitor the progress of a PCR reaction in real-time.
At the same time, a relatively small amount of pcr product (dna, cdna or rna) can be quantified.
Real-time pcr is based on the detection of the fluorescence produced by a reporter molecule which increases, as the reaction proceeds.
Real-time pcr is also known as a quantitative polymerase chain reaction (qpcr), which is a laboratory technique of molecular biology based on the polymerase chain reaction (pcr).
Qpcr is a powerful technique that allows exponential amplification of dna sequences.
A pcr reaction needs a pair of primers that are complementary to the sequence of interest. Primers are extended by the DNA polymerase.
Reverse transcriptase polymerase chain reaction, RT-PCR, is a type of PCR technique that enzymatically amplifies the RNA in vitro.
It is the only type of pcr that can amplify the rna.
It uses a reverse transcriptase enzyme in addition to the other basic components of the pcr.
First, the sample rna is converted to complementary dna (cdna) in reverse transcription, catalyzed by the reverse transcriptase enzyme. These cdna molecules are then used as a template for amplification in the PCR process.
Rt-pcr is used to analyze the mrna or micro rna and study gene expression.
immunoassay of digoxin.pptx (analytical methods of immunoassay)NikitaBankoti2
Immunoassays are bioanalytical methods in which the quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody.
Principle - Immuno assay methods are based on a competitive binding between a fixed amount of labelled form of an analyte and available amount of unlabeled sample analyte for a limited amount of binding sites on a highly specific anti-analyte antibody.
Immunotherapeutics (Types of immunotherapeutics, humanisation antibody therap...NikitaBankoti2
Immunotherapy
➢ Treatment to stimulate or restore the ability of the immune (defence) system to fight
against infection or disease.
➢ It is also sometimes called Biologic therapy or Biotherapy.
➢ Biological therapy is thus any form of treatment that uses the body’s natural abilities
that constitute the immune system to fight infection and disease or to protect the body
from some of the side effects of treatment e.g. – cancer.
Types of Immunotherapeutics
1. Monoclonal antibody
2. Cancer vaccines therapy
3. Immune checkpoint inhibitors
4. Non-specific Immunotherapies
5. Chimeric antigen receptor (CAR) T-cell therapy
Humanized Antibody- They are antibodies from non-human species whose protein sequences have
been modified to increase their similarity to antibody variants produced naturally in humans.
➢The process of humanization is usually applied to monoclonal antibodies developed for administration
to humans. (e.g- antibodies developed as anti-cancer drugs)
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. Clinical Symptoms and
management of
Barbiturates, Morphine,
Organophosphorus compound and
Lead, Mercury and Arsenic poisoning.
Presented by- Nikita Bankoti.
KUDOPSss
2. 1. Barbiturates
Barbiturates are used in medical practice as sedative, hypnotics,
anaesthetic and antiepileptics or in strychnine poisoning cases.
Barbiturates are thus classified into four types,depending on
their time of onset and duration of action.
1.Ultra short acting(<15-20min) - Thiopentane Na ,Hexabarbital
Na.
2.Short acting(<30min) - pentabarbitone,amobarbitone.
3.Intermediate acting(3-6hrs) - amylobarbitone,butobarbitone.
4.Long acting(6-12 hrs) - barbitone,phenobarbital.
MOA - Barbiturates binds to specific site of GABA sensitive ion
channel found in CNS.
It act as a depressant at all level of CNS.
However,depending upon the dose of degree of depression can
be altered from transquility to deep coma.
Eg- increase the action of alcohol(synergistically).
3. Symptoms Of Barbiturate Poisoning:-
1. Prolonged coma with respiratory depression.
2. Hypotension.
3. Pulmonary oedema.(excess fluids in lungs)
4. Hypothermia.(decrease in body temperature)
5. Oliguria.(low urine output)
6. Mental confusion
7. Inco-ordination and Muscle weakness
8. Cardiac arrest.(suddenloss of heart function, breathing)
THE FATAL DOSE IS 50-60grains.
4. Treatment:-
1. Further absorption of barbiturates can be controlled by the
administering activated charcoal.
2. Artificial respiration must be given by a mixture of 95%
oxygen and 5% carbondioxide(CO2).
3. Haemoperfusion and haemodialysis are the available
options for the severe toxicity.
4. Amphetamine sulphate in the dose of 10mg every half an
hour must be given intravenously till improvement occurs.
5. Alkalisation of urine to pH8 with sodium bicarbonate helps
in the elimination of phenobarbitone.
6.Gastric lavage should be performed using potassium
permanganate.
5. 2. Heavy Metal Poisoning:-
Heavy metal block the body enzyme system as they form chelates with the
body enzymes.
A. Arsenic
Symptoms - (i) Acute poisoning:-
1. Nausea, cramps in legs, dilated pupil, vomiting, diarrhoea, faintness, pale
anxious face, malaria, tachycardia(increase in heart beat), burning pain in
stomach, dyspnoea(difficulty in breathing).
2. Vomiting initially consists of stomach content but later it becomes greenish or
black in colour due to the presence of bile.
3. Diarrhoea is complained and stools contain mucous tinged with blood.
4. When arsenic dust is inhaled it may cause pulmonary oedema, restlessness,
cyanosis( bluish discoloration of skin due to poor circulation or inadequate
oxygenation of the blood).
THE FATAL DOSE IS 130-300 mg.
6. Treatment:-
1. Stomach wash with sodium and magnesium sulphate is recommended .
2. Morphine and atropine is given to relieve colic pain.
3. EDTA acts as chelating agent.
Symptoms
(ii) Chronic Toxicity:-
1. Redness of Skin.
2. Loss of weight.
3. Horny growth of cornea.
4. Inflammation of mucous membrane.
5. Coughing.
6. Patchy brown pigmentation of skin.
7. White strips of fingernails.
8. Tenderness of muscles.
7. Treatment:-
1. Dimercaprol 3mg/1kg is administered intramuscularly at
4 hourly intervals.
2. Fluid replacement and use of pressor agents like
dopamine is used to control hypotension.
8.
9.
10. Treatment:-
(i) Acute poisoning:-
1. Gastric lavage with zinc sulphate followed by the large draughts of
milk and eggs with sodium and magnesium sulphate .
2. Morphine and atropine are used to relieve colic pain .
3. EDTA is used as chelating agent.
(ii) Chronic poisoning:-
1. Removal of patient from source of further exposure.
2. Chelation therapy with edetate calcium disodium is used .
3. B.A.L(Dimercaprol)—Birtish anti lewisite is used as complexing
agent.
4. Penicillamine(heavy metal antagonists) is also included in the
dosage regimen.
11. C.Mercury.
Symptoms:-
(i) Acute poisoning:-
1. Inflammation of airways.
2. Metallic taste in mouth.
3. Tremors(shaking or trembling movements).
4. Abdominal pain.
5. Vomiting and vomit consist of long stringy masses of white mucous mixed
with blood.
6. Gums may become swollen and loosening of teeth occur.
7. Pneumonitis(inflammation in your lungs tissues without an infection).
12.
13. (ii) Chronic poisoning:-
1. Anorexia(eating disorder).
2. Excessive salivation.
3. Metallic taste in mouth.
4. Loosening of teeth with painful inflammed gums.
5. Nervous disturbance ,delirium.
6. Weight loss, loss of memory.
7. Insomnia(sleep disorder).
8. GIT disturbances.
FATAL DOSE - 3-5 grams.
Treatment:-
1. Patient must be removed from source of exposure.
2. Forced emesis or gastric lavage is done to remove mercury.
3. I.M. injection of dimercaprol is given.
4. Extract of belladonna can be given to relieve the excessive salivation.
14. 3. Organophosphorus compounds
Insecticides are generally discussed as organo-phosphorous
compounds, D.D.T and Endrin.
The compounds belonging to this category are-
i. Hexaethyl tetra- phosphate(HETP)
ii. Tertraethyl pyrophosphate (TEPP)
iii. Octamethyl pyrophospharamide(OMPA)
FATAL DOSE of HEPA - 160mg by (I.V., I.M.) and 350mg by oral
route.
OMPA- 80mg by (I.M.,I.V)and 175mg by oral route.
15. Symptoms:-
1.The poison affect the involuntory muscles and secretary glands
first.
2. Then it affect the voluntary muscles, and finally vital brain
centers.
3.The initial complaints are-
headache,Malaise(feeling of overall weakness),Constriction in
the chest,accompanied by photo-phobia due to pin-point pupil.
4. In next 2-8 hrs , the symptoms may occur in following order –
nausea, Abdominal cramps, vomiting, Diarrhoea, Profuse
sweating and Salivation, Muscular twitching.
5. If poisoning is severe, symptoms are-
Pulmonary oedema, Convulsions, Possibly death may occur.ss
16. Treatment:-
1. Decontamination - the patient must be removed from the source of
poison. The skin and mucous membrane should be decontaminated
by washing with tap water and soap.
2. Vomiting should be induced if the poison is ingested be the patient.
3. Clearing of air ways- artificial respiration may be necessary to clear
the airway.,
4. Antidote- Atropine 2mg every 15-30 min i.m. or I.V. till it's effects
appear i.e. dry mouth, dilated pupils, false pulse, warm skin etc.
It antagonise the peripheral action of organophosphorus, but cannot
block the effect on CNS and neuromuscular effect.
17. 4. Morphine
It is natural phenanthrene derivative of opium.
Opium is used extensively as a sedative and painkiller.
The various derivatives are also habbit- forming narcotics.
Seeds inside are non-poisonous and called KHASKHAS which
constitutes a condiment in Indian cooking.
Symptoms:-
1.If consumed in large dose, respiration become shallow.
2. Constriction of pupil takes place and Heart rate decreases.
3. Body temperature drops, cyanosis and ultimately death occurs
due to respiratory depression and cardiac arrest.
18. Treatment:-
1. Nalorphine is a specific antidote of morphine. The dose of 5-10mg
is given by I.V. route immediately till respirations become normal.
2. Gastric lavage is done to remove any unabsorbed drug.
3. Patients must be kept awake, as in awake condition ventilation
and basic metabolic rate is more which is responsible for
detoxification of opium.