Clinical trials involve experimental studies performed on people to evaluate medical or behavioral interventions. There are various phases of clinical trials, from initial microdosing and Phase I safety studies involving a small number of participants, to larger Phase II and III studies evaluating effectiveness. Phase IV studies monitor safety and additional uses after approval. Experimental studies can be randomized controlled trials, which are the gold standard, or non-randomized designs. Randomized controlled trials involve a treatment and control group, while other designs may lack a control or randomization.
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From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
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From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
The randomised controlled trial (RCT) .pptxPRITIBISANE
Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment.
Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome
Clinical trials are divided into several phases to ensure the safety and effectiveness of new medical interventions, such as drugs, treatments, or medical devices, before they are approved for widespread use. Here are the typical phases of clinical trials:
Phase 0: Exploratory Study
Phase 0 trials are relatively new and not always a part of the clinical trial process. They involve a small number of participants and aim to gather initial data on how the drug or treatment behaves in the human body. These trials help researchers decide whether to move forward with larger Phase 1 trials.
Phase 1: Safety and Dosage Study
Phase 1 trials involve a small number of healthy volunteers or patients and focus on assessing the safety of the intervention and determining the appropriate dosage range. Researchers closely monitor participants for any adverse effects, evaluate how the intervention is metabolized, and gather initial data on its efficacy.
Phase 2: Expanded Safety and Efficacy Study
Phase 2 trials involve a larger number of patients who have the condition the intervention is intended to treat. These trials continue to assess safety, evaluate dosage regimens, and gather more data on the intervention's efficacy. Researchers may also explore different patient populations, dosages, or combinations with other treatments.
Phase 3: Confirmatory Study
Phase 3 trials are large-scale studies involving a significant number of patients to confirm the intervention's safety, effectiveness, and monitor any side effects. These trials often include a randomized and controlled design, comparing the new intervention against existing standard treatments or placebos. Phase 3 trials provide critical data for regulatory agencies to evaluate whether the intervention should be approved for widespread use.
Phase 4: Post-Marketing Surveillance Study
Phase 4 trials take place after the intervention has received regulatory approval and is available to the general public. They aim to monitor the intervention's long-term safety, effectiveness, and identify any rare or long-term side effects. Phase 4 trials may involve a larger and more diverse population than earlier phases.
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Types of Trials in Medicine, vaccine efficacy or effectiveness trials and rel...Bhoj Raj Singh
The importance of learning about medicines’ and vaccines’ efficacy or effectiveness trials is not only necessary to those who are developing, producing or marketing these pharmaceutical products but to the users also because: The Emergency approval of Covid-19 vaccines and many other medicines in last few years has created so much fuss to understand the reality. The lesson learnt from Covid-19 vaccine(s) by vaccine production, marketing, vaccination and finally the revenue earned by vaccine developers and producers, and political gain by politicians, is proving deleterious to the society as several vaccine(s), useless or scarcely proven safe and useful, are going to infest and some have already infested the market (the health industry). So reading this presentation may be useful to you so that you may question the authorities if any is engaged in bluffing you. The presentation talks briefly about Prevention trials, Screening trials, Treatment trials, Feasibility studies, Pilot studies, Phases in clinical trial, Multi-arm multi-stage (MAMS) trials, Global Clinical Trials, Vaccine efficacy, Vaccine safety, Emergency Use Authorization (EUA), Serious Adverse Events (SAE), SEA rules, The Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), The Advisory Committee on Immunization Practices (ACIP), Clinical Immunization Safety Assessment (CISA), CDSCO Rules Governing Clinical Trials, Schedule Y, The Ethics Committee, Empowered Committee on Animal Health, Tracking Vaccine Quality, Pre-clinical and Clinical data, Proof of Concept, Biological License Application (BLA) and Clinical hold.
The randomised controlled trial (RCT) .pptxPRITIBISANE
Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment.
Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome
Clinical trials are divided into several phases to ensure the safety and effectiveness of new medical interventions, such as drugs, treatments, or medical devices, before they are approved for widespread use. Here are the typical phases of clinical trials:
Phase 0: Exploratory Study
Phase 0 trials are relatively new and not always a part of the clinical trial process. They involve a small number of participants and aim to gather initial data on how the drug or treatment behaves in the human body. These trials help researchers decide whether to move forward with larger Phase 1 trials.
Phase 1: Safety and Dosage Study
Phase 1 trials involve a small number of healthy volunteers or patients and focus on assessing the safety of the intervention and determining the appropriate dosage range. Researchers closely monitor participants for any adverse effects, evaluate how the intervention is metabolized, and gather initial data on its efficacy.
Phase 2: Expanded Safety and Efficacy Study
Phase 2 trials involve a larger number of patients who have the condition the intervention is intended to treat. These trials continue to assess safety, evaluate dosage regimens, and gather more data on the intervention's efficacy. Researchers may also explore different patient populations, dosages, or combinations with other treatments.
Phase 3: Confirmatory Study
Phase 3 trials are large-scale studies involving a significant number of patients to confirm the intervention's safety, effectiveness, and monitor any side effects. These trials often include a randomized and controlled design, comparing the new intervention against existing standard treatments or placebos. Phase 3 trials provide critical data for regulatory agencies to evaluate whether the intervention should be approved for widespread use.
Phase 4: Post-Marketing Surveillance Study
Phase 4 trials take place after the intervention has received regulatory approval and is available to the general public. They aim to monitor the intervention's long-term safety, effectiveness, and identify any rare or long-term side effects. Phase 4 trials may involve a larger and more diverse population than earlier phases.
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
Dr. Daniel Kaufer's live presentation made at the LBDA hosted webinar of June 15, 2016. Review additional material and event recording at www.worldeventsforum.net/lbda and lbda.org
Types of Trials in Medicine, vaccine efficacy or effectiveness trials and rel...Bhoj Raj Singh
The importance of learning about medicines’ and vaccines’ efficacy or effectiveness trials is not only necessary to those who are developing, producing or marketing these pharmaceutical products but to the users also because: The Emergency approval of Covid-19 vaccines and many other medicines in last few years has created so much fuss to understand the reality. The lesson learnt from Covid-19 vaccine(s) by vaccine production, marketing, vaccination and finally the revenue earned by vaccine developers and producers, and political gain by politicians, is proving deleterious to the society as several vaccine(s), useless or scarcely proven safe and useful, are going to infest and some have already infested the market (the health industry). So reading this presentation may be useful to you so that you may question the authorities if any is engaged in bluffing you. The presentation talks briefly about Prevention trials, Screening trials, Treatment trials, Feasibility studies, Pilot studies, Phases in clinical trial, Multi-arm multi-stage (MAMS) trials, Global Clinical Trials, Vaccine efficacy, Vaccine safety, Emergency Use Authorization (EUA), Serious Adverse Events (SAE), SEA rules, The Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), The Advisory Committee on Immunization Practices (ACIP), Clinical Immunization Safety Assessment (CISA), CDSCO Rules Governing Clinical Trials, Schedule Y, The Ethics Committee, Empowered Committee on Animal Health, Tracking Vaccine Quality, Pre-clinical and Clinical data, Proof of Concept, Biological License Application (BLA) and Clinical hold.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
sources in the solar corona and is highly structured. It is often described
as high-speed, relatively homogeneous, plasma streams from coronal
holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
1. Clinical Trials – Types & Design
Experimental studies
Submitted To – Mrs. Anuradha
Submitted by – Kirti
1301
M. Pharm (Pharmacology)
Maharshi Dayanand University, Rohtak
2. Clinical Trials - Types & Design
• Clinical trials – Clinical trials are research studies performed in people that are
aimed at evaluation a medical, surgical or behavioural intervention.
• Clinical Trials are the primary way that researchers find out if a new treatment,
like a new drug or diet or medical devices is safe and effective in people.
• A clinical trial is used to learn if a new treatment is more effective and has less
harmful side effects than the standard treatment.
• Therefore the authorities like FDA approves a clinical trial to began, scientists
perform laboratory tests and studies in animals to test a potential therapy’s
safety and efficacy. If these studies show favourable results, the authorities
gives approval for the interventions to be tested in humans.
3. Phases of Clinical Trials
• Phase 0 (Microdosing Study)
• Phase 1 (Dose Ranging & Safety )
• Phase 2 (Therapeutic Exploratory Trial)
• Phase 3 (Therapeutic Confirmatory Trial)
• Phase 4 (Post Marketing Surveillance)
Phase 0 (Microdosing Study)
Use only a few small doses of a new drug in a few people. They might test whether drug
reaches tumor, how drug act in human body, how cancer cells in human body respond to
the drug.
4. Phase I
• An experimental treatment on a small group of often healthy people (20-80)
to judge it’s safety and side effects and to find the correct drug doses.
• Objective – To determine the metabolic and pharmacological actions and the
maximally tolerated dose.
• Factors to be identified – Pharmacokinetics, Pharmacodynamics,
Bioavailability, Metabolism, bioequivalence.
• Duration – upto 1 month.
• Sample Size – 20-80
• Population – Healthy volunteers or Individuals with the target disease (such
as – Cancer or HIV ).
5. Phase II
• The Emphasis in phase II is on effectiveness. These trials also continue to study
safety, including short term side effects
• Objective – to evaluate effectiveness, determine the short term – side effects and
identify common risk for a specific population & diseases.
• Factors to be identified – Bioavailability, Drug – Disease interaction, Drug –Drug
interactions, Efficacy at various doses, Pharmacodynamics, pharmacokinetics,
patient safety.
• Duration – Several months.
• Sample Size – 200-300
• Population – Individuals with target disease
6. Phase III
• It gather more information about safety & Effectiveness. Studying different
population & different dosages, using the drug in combination with other
drugs.
• If the authorities like - FDA aggrees that the trials results are positive, it will
approve the experimental drug or devices.
• Objective – to evaluate the overall risk – benefits ratio in a demographically
diverse sample.
• Factors to be identified – Drug-disease interaction’s, Drug-Drug interaction’s,
risk-benefit information, efficacy & safety for sub groups, dosage intervals.
• Duration- Several Years
• Sample Size -100-1000
• Population – individual with target diseases.
7. Phase IV
• Used for drugs or devices takes place after the authorities like FDA approves
their use. Sometimes the side effects of a drug may not become clear until
more people have taken it over a longer period of time.
• Objective – To monitor ongoing safety in large population’s & identify
additional uses of the agent that might be approved by the FDA.
• Factors to be identified – efficacy and safety within large, diverse population’s,
pharmacoeconomics
• Duration – ongoing (following FDA approval)
• Sample Size – thousands
• Population – individuals with target disease as well as new age group, genders
etc.
9. Experimental Studies
• Experimental studies also known as interventional studies. The national
institute of health (NIH) defined an interventional studies as individuals in
which “participants receive specific interventions according to the research
plan created by the investigator. These interventions may be drug, device ,
method.
• It is further classified on the basis of randomization. Randomization is the
heart of the experimental studies.
10. A. Randomized Controlled Studies
Randomized controlled study design is the highly reliable design and it is high level
evidence to practice health profession. As the name indicates, control group is
present as a comparator to the interventional group.
In this study interventional group receives interventional drug and control group
receive either old drug or placebo.
For randomized controlled study is also named as
- Clinical Trials
- Gold standard study
11. 1. Parallel Studies
• A parallel Study is a type of clinical study where treatment and controls are
allocated to different individuals.
• In this two groups of treatments are given so that one group recieves only one
type of treatment and another group receives other treatment.
12. 2. Cross over studies
• In this type of studies each patient serves as his own control. Each
patient gets both treatment.
• Each patient receives first treatment then wash out time is provided
then other treatment is provided to the same patient.
13. Randomized Uncontrolled Studies
• In this study there is no control group present only one group present
with randomization. It is so weaker when this study compared with
the randomized controlled study.
randomized study population
Interventional group
Interventional Drug
Outcomes measured
14. B. Non-randomized Studies
1. Non randomized controlled Study-
• The study is same that of the randomized control study but without
randomization.
• The control group receive placebo or old drug and interventional group receives
interventional drug and then outcomes measured. Sometimes hospital records
data obtained from published literature can be used as a control group, such non-
randomized or non-current studies named as historical control study.
15. 2. Non-randomized uncontrolled study -
• This study is also same as that of randomized Uncontrolled study but without
randomization & control group.
• Outcomes measured finally after the collection.
Non Randomized Population
Interventional Group
Interventional Drug
Outcome measured
16. C. Others
1. Latin Square
• Latin Square design helpful to study more than the one treatment
simultaneously to understand the usefulness of each treatment by the
comparison.
For example, four treatments namely – A,B,C,D then latin Square is applied ( four
replications of each treatment) as follows and do comparison.
17. 2. Factorial Randomized Study
• Studies involving two or more factors while randomizing are called factorial.
• In this study, only one control group and two interventional groups are present.
• The results of each group comparing with the control group, and with the help
of this study we can access at a time two factors ( treatment and doses form).
• Used when it is desired to study the influence of a number of factors on the
treatments compared as well as their interaction with different treatments
factors on a dependent variables
18. 3. Cluster Randomized Design -
• In cluster Design group of participants are randomized & made into clusters
• Individuals are randomized in a group.
• Example- A group include, school in a city, religion, occupation in an area,
hospitals in a city.
• It is simple to randomized the participants by groups.
• The data are also collected group wise.
20. 9. M N Parikh, Nithya Gogtay. ABC of research methodology and applied biostatistics a
primer for clinicians and researchers. Published by Jaypee Brothers medical Publishers (P)
Ltd, New Delhi, India, 2009.
10. P S S Sundar Rao, J Richard. Introduction to biostatistics and research methodology.
Published by Phi Learning (P) Ltd, New Delhi, India, 2009.
11. R Raveendran, B Gitanjali, S Manikandan. A practical approach to PG dissertation.
Published by Pharma Med Press, Hyderabad, 2014.
12. Center for Disease Control and Prevention Principles of Epidemiology in Public
Health Practice, 3rd ed, Published by U.S Department of Health and Human Services, 2010.
13. K G Revi Kumar, B D Miglani. A text book of pharmacy practice. Published by
Career Publications, Maharashtra, India, 2012.
14. Justin Besen, Stephanie D Gan. A critical evaluation of clinical research study designs.
Journal of Investigative Dermatology, 134, 2014.
15. http://en.wikipedia.org/wiki/Cross-sectional_study.
21. 16. Jesper Hallas, pharmacoepidemiolog-current oppurtunities and challenges,
Norwegian Journal of Epidemiology, 11(1):7-12, 2001.
17. Brian L.Strom, Stephen E.Kennel, Sean Hennessy. Text book of
pharmacoepidemiology. Published by Wiley Black Well, UK, 2013.
18. Mohit Bhandari, Parag Sachet. Clinical research made easy. Published by Jaypee
Brothers medical Publishers (P) Ltd, New Delhi, India, 2010.
19. D Sudheer Kumar, Dr.J.Krishna Veni, Dr.P.Manjula. Fundamentals of clinical
pharmacy practice. Published by Pharma Med Press, Hyderabad, 2010.
20. Dr.H.P.Tipnis, Dr.Amrita Bajaj, Clinical pharmacy, Published by Carrer Publications,
India, 2013. 21. httpwww.iarc.frenpublicationspdfs-onlineepicancerepiCancerEpi-5.pdf
22. B Gitanjali, Pharmacoepidemiology in India: falling into a rut. IJP, 35:137-138, 2003.
