molecular docking its types and de novo drug design and application and softw...GAUTAM KHUNE
This ppt deals with all the aspects related to molecular docking ,its types(rigid ,flexible and manual) and screening based on it and also deals with de novo drug design , various softwares available for docking methodologies and applications for molecular docking in new drug design
molecular docking its types and de novo drug design and application and softw...GAUTAM KHUNE
This ppt deals with all the aspects related to molecular docking ,its types(rigid ,flexible and manual) and screening based on it and also deals with de novo drug design , various softwares available for docking methodologies and applications for molecular docking in new drug design
Role of Target Identification and Target Validation in Drug Discovery ProcessPallavi Duggal
Target identification and Validation tells about the how target is neccesary for new drug discovery and its development to reach into market for rare diseases.
The basic aspects of drug discovery starts from target discovery and validation further going to lead identification and optimization. In this particular slide discussion is regarding the target discovery and the tools that have been utilized in this process.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Target identification, target validation, lead identification and lead
Optimization.
• Economics of drug discovery.
• Target Discovery and validation-Role of Genomics, Proteomics and
Bioinformatics.
• Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins.
• Role of transgenic animals in target validation.
Target Validation
Introduction,Drug discovery, Target identification and validation, Target validation and techniques
By
Ms. B. Mary Vishali
Department of Pharmacology
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
In silico drug designing is the drug design which can be carried out in silicon chip,i.e., within computers. The slides are helpful to know a brief description about in silico drug designing.
Role of Target Identification and Target Validation in Drug Discovery ProcessPallavi Duggal
Target identification and Validation tells about the how target is neccesary for new drug discovery and its development to reach into market for rare diseases.
The basic aspects of drug discovery starts from target discovery and validation further going to lead identification and optimization. In this particular slide discussion is regarding the target discovery and the tools that have been utilized in this process.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
Target identification, target validation, lead identification and lead
Optimization.
• Economics of drug discovery.
• Target Discovery and validation-Role of Genomics, Proteomics and
Bioinformatics.
• Role of Nucleic acid microarrays, Protein microarrays, Antisense
technologies, siRNAs, antisense oligonucleotides, Zinc finger proteins.
• Role of transgenic animals in target validation.
Target Validation
Introduction,Drug discovery, Target identification and validation, Target validation and techniques
By
Ms. B. Mary Vishali
Department of Pharmacology
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
In silico drug designing is the drug design which can be carried out in silicon chip,i.e., within computers. The slides are helpful to know a brief description about in silico drug designing.
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
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.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
Drug development is considered as a series of well defined steps, culminating, if successful, in market authorization, of the drug
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
A review on stages of drug development and alternative methods for animal stu...Frinto Francis
Various Stages of drug development, anaesthesia ,euthanasia, animals used for preclinical analysis, clinical trials, alternative methods for animal testing, blood withdrawal methods, ethical guidelines
Mechanism of pathogenicity-Exotoxin and endotoxinaiswarya thomas
Brief description on mechanisms of pathogenicity, actions of toxins produced by various bacteria and notable endotoxins and exotoxins. Mechanism of action of some of the commonest endotoxins and exotoxins are explained.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
various measures for the measurement of outcome such as incidence prevalence and other drug us measures are briefly discussed here with suitable examples and equations
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
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.
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
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
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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.
- 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
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.
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!
2. Drug…
Any chemical that produces a change in the
body…
Defined by characteristics:
1. Use or potential use in diagnosis or treatment
of disease
2. Selective in their actions
3. Need for Drug Discovery
Unmet Medical Needs:
New Diseases ,AIDS, Alzheimer’s, obesity
Low efficacy – dementia, cancer
Side effects – antipsychotics, antidepressants
Downstream health cost - (Alzheimer’s; spinal
injury)
cost of therapy; (Interleukins)
costs to individual/country; (depression)
Sustain industrial activity; pharmaceutical
industry employs thousands and makes a massive
contribution to overseas earnings; patent expiry
4. The changed context of drug
discovery and development
HISTORICAL ASPECTS
1537-first clinical trial of a novel therapy by
Amboise pare
1747-James Lind introduced control groups in
experiment, document citrus fruits in the diet
prevent scurvy
1863- Placebos were first used
1923-concept of randomisation introduced
1931-concept of randomisation of patients to
treatment in clinical trials
1945-ethical impact of clinical trial has become
5. 1947-thse regulations enshrined in Nuremberg
codex
1948-1st trial using properly randomised treatment
and control groupss by medical research counsil
1964- introduction of declaration of Helsinki
Amended in 1975, 1983, 1989, 1996, 2000, 2002
and 2004
6. Drug development
Drug development-The entire process of taking a
newly discovered compound or drug through
regulatory approval to the point of marketing.
During the development, the new drug or the
compound should adhere to high standards in the
conduct, analysis and interpretation of
preclinical and clinical studies for its smooth
passage through the regulatory approval phase
and eventually to marketing.
Pathways of drug development are
Discovery
Preclinical development
Clinical development
11. Pre-discovery
Understanding the disease
Know the underlying cause for the disease
Try to understand how genes are altered – how they affect
proteins they encode
How proteins interact with each other in living cells
How those affected cells change the specific tissue they
are in
12. How drug works….
The cells in the body carry out complex molecular
reactions
A mistake in one reaction might stop an important
protein from being produced or over-produced –
leads to body not producing enough cells (diabetes)
or over production of cells (cancer)
Drug molecule affect these pathways by interacting
with certain molecules along the pathway – making
them more or less active or changing their activity
13. Drug discovery
Drug discovery begins in the laboratory with scientists
of various functional areas working together to identify
cellular and genetic factors that play a role in specific
disease
Identification of target and resource
4 steps
14. Target Selection
Biochemical Classes of Drug Targets
G-protein coupled receptors - 45%
enzymes - 28%
hormones and factors - 11%
ion channels - 5%
nuclear receptors - 2%
15. Target Identification
Drugs usually act on either cellular or genetic
chemicals in the body, known as targets,
which are believed to be associated with
disease.
Scientists use a variety of techniques to
identify and isolate individual targets to learn
more about their functions and how they
influence disease.
Compounds are then identified that have
various interactions with the drug targets that
16. Cellular & Genetic Targets
involves identification of the target receptors or
enzymes whereas for some biologic approaches
the focus is at the gene or transcription level.
Drugs usually act on the targets, which are
associated with disease.
17. Genomics
The study of genes and their function.
exploit the findings from the sequencing of the
human and other genomes to find new drug
targets.
Based on 5 or 10 linked proteins per gene,
proposes that the number of potential drug
targets may lie between 5,000 and 10,000.
18. Proteomics
It is also at the protein level that disease processes
become manifest, and at which most (91%) drugs act.
Therefore, the analysis of proteins (including protein-
protein, protein-nucleic acid, and protein ligand
interactions) will be utmost importance to target
discovery.
Target identification with proteomics is performed by
comparing the protein expression levels in normal and
diseased tissues.
19. Bioinformatics
It plays a key role in various stages of the drug
discovery process including
target identification
computer screening of chemical compounds and
pharmacogenomics
Can compare the entire genome of pathogenic and
non-pathogenic strains of a microbe and identify
genes/proteins associated with pathogenism
20. Target Prioritization/Validation.
To select targets most likely to be useful in the
development of new treatments for disease,
researchers analyze and compare each drug
target to others based on their association with a
specific disease and their ability to regulate
biological and chemical compounds in the body.
Tests are conducted to confirm that interactions
with the drug target are associated with a
desired change in the behavior of diseased cells.
Research scientists can then identify
compounds that have an effect on the target
selected.
21.
22. Lead Identification.
A lead compound or substance is one that
is believed to have potential to treat
disease.
Laboratory scientists can compare known
substances with new compounds to
determine their likelihood of success.
Leads are sometimes developed as
collections, or libraries, of individual
molecules that possess properties needed
in a new drug.
Testing is then done on each of these
molecules to confirm its effect on the drug
23. Find a promising molecule that could become a drug
Ways to find a lead compound
o Nature – bacteria, molds, plant extracts
o De Novo – scientists can also create molecules from scratch –
computer modeling
o High throughput screening – test thousands of compounds
against the target to identify any that might be promising
o Biotechnology – scientists can genetically engineer living
systems to produce disease-fighting biological molecules
24. Lead discovery
• Identification of small molecule modulators
of protein function
• The process of transforming these into high-
content lead series.
Synthesis and Isolation
• Separation of mixture
• Separation of impurities
• In vitro chemical synthesis
• Biosynthetic intermediate
25. Combinatorial Chemistry
Rapid synthesis of or computer simulation of large no. of different
but structurally related molecules
• Search new leads
• Optimization of target affinity & selectivity.
• ADME properties
• Reduce toxicity and eliminate side effects
Assay Development
• Used for measuring the activity of a drug.
• Discriminate between compounds.
• Evaluate:
• Expressed protein targets.
• Enzyme/ substrate interactions.
26. High Throughput Screening
• Screening of drug target against selection of
chemicals.
• Identification of highly target specific
compounds.
27. Lead Optimization.
Lead optimization compares the properties of
various lead compounds and provides
information to help biopharmaceutical
companies select the compound or
compounds with the greatest potential to be
developed into safe and effective medicines.
Often during this same stage of development,
lead prioritization studies are conducted in
living organisms (in vivo) and in cells in the
test tube (in vitro) to compare various lead
compounds and how they are metabolized
28. Optimization
o Alter the structure of lead candidates to improve
properties
o can make it less likely to interact with other chemical
pathways in the body, thus reducing the potential for
side effects
“analogues” of the initial leads can be made and
tested
The biologists test the effects of analogues on
biological systems
Chemists take this information to make additional
alterations that are then retested by the biologists
29. Early safety tests
o Lead compounds go through a series of tests to provide an early
assessment of the safety.
o Scientists test Absorption, Distribution, Metabolism, Excretion
and Toxicological (ADME/Tox) properties, or “pharmacokinetics,”
of each lead.
Successful drugs must be:
o absorbed into the bloodstream,
o distributed to the proper site of action in the body,
o metabolized efficiently and effectively,
o successfully excreted from the body and
o demonstrated to be not toxic.
Help researchers prioritize lead compounds early in the
discovery process.
ADME/Tox studies are performed in living cells, in animals and
30. Preclinical
Conversion of drug candidate to a drug product for
human clinical trials
Lab and animal testing to determine if the drug is safe
enough for human testing
Testing the lead compounds extensively to determine if
they should move on to testing in humans
Scientists carry out in vitro and in vivo tests.
Scientists try to understand how the drug works and
what its safety profile looks like.
32. Pharmacological & Toxicological
approach
Pharmacology - Drug action:
Behaviour and reaction
Physiology
Histopathology
Toxicology:
Acute toxicity
Subchronic toxicity
Tissue specific toxicity
Tolerability
33. THE DRUG DEVELOPMENT
PROCESS Development
Discovery Development
Approximately 10–15 years from idea to marketable drug
Preclinical studies Clinical studies
CHEMISTRY/
PHARMA-
COLOGY
IND* PHASE I PHASE II PHASE III NDA** PHASE IV
Search for
active
substances
Toxicology,
efficacy studies
on various
types of
animals
Regulatory
review
Efficacy
studies on
healthy
volunteers
Clinical studies
on a limited
scale
Comparative
studies on a
large number
of patients
Regulatory
review
Continued
comparative
studies*Investigational
New Drug
Application for
permission to
administer a new drug
to humans
50–150
persons
100–200
patients
500–5,000
patients
Registration,
market
introduction
**New Drug Application
Application for permission
to market
a new drug
KNOWLEDGE
LEVEL
KNOWLEDGE
LEVEL
2–4 YEARS 2–6 MONTHS 3–6 YEARS 1–3 YEARS
TIME SPAN
Early Clinical
1.Candidate drug emerges from a drug discovery programme. Candidate must complete a series of evaluations of its potential safety and efficacy and must be amenable to mass production.for each drug completing the pathway,5000-10000 are evaluated in the discovery phase
There are various ways of illustrating the R&D process – this is one. We see, among other things, how knowledge about a drug increases during the course of the process, but that upon market introduction, there is still a great deal to be learned about how the drug works in the body. Developing a new drug is a complex and costly process.
If everything goes according to plan, a new drug will be ready approximately ten years after the work was first begun. We are working to shorten this time to eight years.
Pharmaceutical companies are constantly striving to shorten the time from idea to finished pharmaceutical product. At the same time, the demands on documentation continue to rise.