Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
n drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. This guideline provides a definition, general principles and recommendations for safety pharmacology studies
Safety pharmacology studies in drug developmentAnkita
In the given ppt we get idea about safety pharmacology studies. learn why safety pharmacology is important. concept of safety pharmacology, also get the knowledge from where safety pharmacology is originated
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
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
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
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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3. PRECLINICAL TRIALS
• Preclinical trials or non clinical trials – are laboratory
test of a new drug substance or medical devices,
usually done on animal subjects, to see whether the
treatment really works and if it is safe to test on
humans.
• The main goals of pre-clinical studies are to
determine a product's ultimate safety profile.
• Products may include new medical devices, drugs,
gene therapy solutions, etc.
4. • After identifying a compound, it is tested on
animals to expose the whole pharmacological
profile.
• Experiments are generally performed on rodent
like mouse, rat, guinea pig, hamster, rabbit.
• After successful result, experiments are
performed on larger animals like cat, dog,
monkey.
• As the evaluation progresses unfavorable
compounds get rejected at each step.
• So, that only few out of thousands reach the
stage when administration to man is considered.
7. THERE ARE SEVERAL STEPS
INVOLVED WITH DOING A PRE-CLINICAL
TRIAL:
File for approval as an Investigational New Drug
5 (IND)
4
Establish Effective and Toxic Doses
3
Screen the Drug in the Assay
2
Develop a Bioassay
1
Indentify a Drug Target
8. OBJECTIVES OF PRECLINICAL
STUDIES
• The purpose of pre-clinical study is to develop
adequate data to decide that it is reasonably
safe to proceed with human trials of the drug.
• Means, a laboratory test of a new drug or a new
medical device, usually done on animal subjects,
to see if the treatment really works and if it is
safe to test on humans
• However the main objective is to collect the data
to submit to the FDA for IND filing.
9. THE TYPES OF STUDIES INCLUDED IN
PRECLINICAL TRIALS
1.Screening Test
2. Tests on isolated organs, bacterial cultures
3. Tests on animal models of human disease
4. General observational test
5. Confirmatory tests and analogous activities
6. Mechanism of action
7. Systemic pharmacology
8. Quantitative test
9. Pharmacokinetics
10. Toxicity test
10. 1. Screening test:
These are simple and rapidly performed tests
to indicate presence OR absence of a particular
pharmacodynamic activity.
For example, analgesic OR hypoglycemic
activity.
2. Tests on isolated organs, bacterial cultures:
These also are preliminary tests to detect
specific activity, such as anti-histaminic, anti-secretory,
vasodilator, antibacterial, etc
11. 3. Tests on animal models of human disease:
Animal models used such as kindled seizures in rats,
genetically hypersensitive rats, experimental
tuberculosis in mouse, etc.
4. General observational test:
Drug is injected in tripling doses to small
groups of mice which are observed for overt
(hidden) effects.
Preliminary clues are drawn from the profile of
effect observed.
12. 5.Confirmatory tests and analogous activities:
Compounds found active are taken up for detailed
study by more elaborate (Complex) tests which
confirm and characterize the activity.
Other related activities also measured, like
antipyretic and anti-inflammatory activity in an
analgesic.
6. Mechanism of action:
Attempts are made to find out the mechanism of
action.
E.g. whether an anti-hypertensive is an α blocker/β
blocker/ ACE inhibitor/ calcium channel blocker,
etc.
13. 7. Systemic pharmacology:
• Irrespective of the primary action of the
drug, its effect on major organ systems
such as nervous, cardio-vascular,
respiratory, renal are worked out.
8. Quantitative test:
The dose-response relationship, maximal
effects and comparative efficacy with
existing drug is carried out.
14. • 9. Pharmacokinetics:
• The dose-response relationship, maximal effects and
comparative efficacy with existing drug is carried
out.
• 10. Toxicity test:
Acute toxicity:
• Single high doses are given to small groups of animals
that are observed for overt (hidden) effects and
mortality for 1-3 days.
• The dose which kills 50% animals is called as LD50.
• Organ toxicity is examined by histopathology on all
animals.
15. • These whole tests are carried out under
standardize procedure under “Good
Laboratory Practice” (GLP).
• GLP applies to non-clinical studies
conducted for the assessment of the
safety or efficacy of chemicals (including
pharmaceuticals) to man, animals and the
environment
16. • GLP specifically refers to a quality system of
research laboratories and organizations to try to
ensure the uniformity, consistency, reliability,
reproducibility, quality, and integrity of chemical
(including pharmaceuticals) non-clinical safety
tests; from physicochemical properties through
acute to chronic toxicity tests.
• The original GLP regulatory mandate was
promulgated in 1978 by US-FDA and published in
the Federal Register 43 FR 59985-60020.
17. 21 CFR 312.38
• Before the human studies can begin, an IND must be
submitted to the Agency containing, among other
things, information on any risks anticipated based on
the results of pharmacologic and toxicological data
collected during studies of the drug in animals (21
CFR 312.23(a)(8)). These basic safety tests are most
often performed in rats and dogs.
• Pharmacology and toxicology information: Adequate
information about the pharmacological and
toxicological studies of the drug involving laboratory
animals, or in vitro on the basis of which the the
sponsor has concluded that it is reasonably safe to
conduct the proposed clinical investigations.
18. Guidance documents are available from FDA that
describe ways in which these requirements may be
met.
Such information is required to include the
identification and qualifications of the individuals
who evaluated the results of such studies and
concluded that it is reasonably safe to begin the
proposed investigations and a statement of where
the investigations were conducted and where the
records are available for inspection.
As drug development proceeds, the sponsor is
required to submit informational amendments, as
appropriate, with additional information pertinent
to safety.
19. 1.PHARMACOLOGY AND DRUG
DISPOSITION.
• A section describing the pharmacological
effects and mechanism(s) of action of the
drug in animals, and information on the
absorption, distribution, metabolism, and
excretion of the drug, if known.
20. 2.TOXICOLOGY
(a ) An integrated summary of the toxicological
effects of the drug in animals and in vitro.
Depending on the nature of the drug and the
phase of the investigation, the description is to
include the results of acute, subacute, and
chronic toxicity tests; tests of the drug's
effects on reproduction and the developing
fetus; any special toxicity test related to the
drug's particular mode of administration or
conditions of use (e.g., inhalation, dermal, or
ocular toxicology); and any in vitro studies
intended to evaluate drug toxicity.
21. (b ) For each toxicology study that is intended
primarily to support the safety of the proposed
clinical investigation, a full tabulation of data
suitable for detailed review.
(c) For each nonclinical laboratory study
subject to the good laboratory practice
regulations under part 58, a statement that the
study was conducted in compliance with the
good laboratory practice regulations in part 58,
or, if the study was not conducted in compliance
with those regulations, a brief statement of the
reason for the noncompliance.
22. IMPORTANCE OF PRECLINICAL TRIALS
• To determine the dose, toxic dose,
pharmacological action, etc.
• It is the requirement of regulatory body
for performing clinical trials.
• As ethical view point, it is necessary to
check safety of drug on animals before
starting to check on human being.
• To check the kinetic profile of drug &
based on it, select the route of
administration in human for clinical trials.