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
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Dermal Irritation and Dermal Toxicity Studies Dinesh Gangoda
Dermal irritation and Corrosion test guidelines 204.
Dermal irritation is the production of reversible damage of the skin following the application of a test chemical for up to 4 hours.
Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. [1]
Dermal corrosion is the production of irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test chemical for up to four hours.[2]
REFERENCES
OECD/OCDE, Test No. 404: ‘‘Acute Dermal Irritation/Corrosion’’, 28 July 2015 OECD Publishing, peris, Page no, 1- 8.
Robert A., Turner., Screening Methods in Pharmacology; 1st edition; Academic press an imprint of Elsevier, pp, 279- 281.
OECD Guideline for testing of chemicals (1981). ‘‘Repeated Dose Dermal Toxicity’’, 21/28- day Study.
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
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
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
REPRODUCTIVE TOXICITY STUDIES, Definition
Introduction, OECD guidelines for reproductive toxicity studies
Principle of the test, Description of Method, Procedure, Experimental Schedule, Data and Reporting, Results, Male Fertility Toxicological Studies
Ms. I. Sai Reddemma.
Department of Pharmacology
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
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
Pharmacological Approach to Drug DiscoverySuhas Reddy C
For better understanding of students. This will give you a detailed explanation of Pharmacological approach. Contact me through comment section if you need any assistance in understating
safety pharmacology is the branch of pharmacology specializing in detecting and investigating potential undesirable pharmacodynamic effects of a new chemical on physiological functions .
the content of this presentation is as follows
- introduction
- definition
- history
- ICH - guidelines
- refrences
This presentation provides a knowledge about Safety Pharmacology, It's aim & objectives, issues, consideration in selection and design of study and test study, duration of study, various studies involved in safety pharmacology, its guidelines, preclinical safety pharmacology. An assignment for the subject, Clinical Research and Pharmacovigilance, 1st year M.Pharm, 2nd semester.
S3A: NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES
S3B: PHARMACOKINETICS: GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES
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.
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy
Extrapolation of in vitro data to preclinical and.pptxARSHIKHANAM4
Extrapolation of in vitro data to preclinical.
the topic is included in m.pharmacy 1st sem syllabus. which is essential for the study and that include the details about how you deal with the preclinical data that will help to decide the NOEAL and LOEAL, the humane dose of the drug can be calculated and further formation is also done.
Similar to Safety Pharmacology Studies ICH guideline S7A (20)
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
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
- 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
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.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
1. Safety Pharmacology
Presented by:
Farhan Shaikh
(M. Pharm II Sem)
Guided by: Dr. C. R. Patil Sir
Dept. of Pharmacology
R.C. Patel Institute of Pharmaceutical Education and
Resesrch , Shirpur.
1
2. CONTENTS
1. INTRODUCTION
1.1 Objectives Of The Guideline
1.2 General Principle
1.3 Definition Of Safety Pharmacology
2. Guideline
2.1 Objectives Of Studies
2.2 General Consideration In
Selection/Design
2.3 Test Systems
2.4 Dose Levels/Concentrations
2.5 Duration Of Studies
2.6 Core Battery
2.7 Follow-up And Supplemental Studies
2.8 Application Of GLP
2.9 Reference
2
3. • 1.1 Objectives of the Guideline
To help and protect clinical trial participants and patients receiving
marketed products from potential adverse effects of pharmaceuticals,
while avoiding unnecessary use of animals and other resources.
3
4. To adopt a rational approach when selecting and conducting safety pharmacology
studies.
Rational Approach in Design and Conduct Based on Pharmaceutical’s Properties and
Uses
Scientifically Valid Methods
Use of New Technologies and Methodologies is Encouraged
Potential to Incorporate SP End points into Toxicology, Kinetics, Clinical studies etc.
1.2 General Principle
4
5. Pharmacology studies can be divided into three categories:
Primary pharmacodynamic.
Secondary pharmacodynamic.
Safety pharmacology studies.
5
6. 2. GUIDELINE (S7A)
• Has clarified many expects of safety pharmacological study
6
7. The objectives of safety pharmacology studies are:
1) To identify undesirable pharmacodynamic properties of a substance that may
have relevance to its human safety;
2) To evaluate adverse pharmacodynamic and/or pathophysiological effects of a
substance observed in toxicology and/or clinical studies; and
3) To investigate the mechanism of the adverse pharmacodynamic effects observed
and/or suspected.
7
2.1 Objectives of Studies:
8. 2.2 General Consideration In Selection/Design
It will depended upon the specific properties of each test substance, the
studies should be selected and designed accordingly. The following factors
should be considered:
1) Effects related to the therapeutic class of the test substance, since the
mechanism of action may suggest specific adverse effects.
2) Adverse effects associated with members of the chemical or therapeutic
class, but independent of the primary pharmacodynamic effects .
8
9. 3) Ligand binding or enzyme assay data suggesting a potential for
adverse effects;
4) Results from previous safety pharmacology studies, from secondary
pharmacodynamic studies, from toxicology studies, or from human use
that warrant further investigation to establish and characterize the
relevance of these findings to potential adverse effects in humans.
9
10. 2.3 Test Systems
General Considerations on Test Systems:
• Consideration should be given to the selection of relevant animal models or
other test systems so that scientifically valid information can be derived.
• Selection factors can include the pharmacodynamic responsiveness of the
model, pharmacokinetic profile, species, strain, gender and age of the
experimental animals, the susceptibility, sensitivity, and reproducibility of
the test system.
10
11. Animal models as well as ex vivo and in vitro preparations can be used as
test systems. Ex vivo and in vitro systems can include, but are not limited
to: isolated organs and tissues, cell cultures, cellular fragments, subcellular
organelles, receptors, ion channels, transporters and enzymes. In vitro
systems can be used in supportive studies (e.g., to obtain a profile of the
activity of the substance or to investigate the mechanism of effects
observed in vivo).
11
Use of In Vivo and In Vitro Studies:
12. Experimental Design:
Sample Size and Use of Controls :
• The size of the groups should be sufficient to allow meaningful scientific interpretation
of the data generated.
• Thus, the number of animals or isolated preparations should be adequate to demonstrate
or rule out the presence of a biologically significant effect of the test substance.
• The size of the biological effect that is of concern for humans. Appropriate negative and
positive control groups should be included in the experimental design.
12
13. Route of Administration
Exposure achieved similar to or greater than in humans
If clinical use involves multiple routes, consider more than one route
The expected clinical route of administration should be used when
feasible.
13
14. 2.4 Dose Levels or Concentrations of Test Substance
• In Vivo Studies
• Safety pharmacology studies should be designed to define the dose-response
relationship of the adverse effect observed.
• The time course (e.g., onset and duration of response) of the adverse effect should
be investigated.
• Generally, the doses eliciting the adverse effect should be compared to the doses
eliciting the primary pharmacodynamic effect in the test species or the proposed
therapeutic effect in humans.
14
15. In Vitro Studies:
• In vitro studies should be designed to establish a concentration-effect
relationship.
• The range of concentrations used should be selected to increase the
likelihood of detecting an effect on the test system.
• The upper limit of this range may be influenced by physicochemical
properties of the test substance and other assay specific factors.
15
16. Duration of Studies:
•Generally single dose
•Consider repeat dose when:
-PD effect only after a certain duration
-Concerns from repeat dose nonclinical studies and human use
16
17. • The safety pharmacology core battery is to investigate the effects of
the test substance on vital functions. In this regard, the cardiovascular,
respiratory and central nervous systems are usually considered the
vital organ systems that should be studied in the core battery.
17
18. Effects of the test substance on the central nervous system should be
assessed appropriately.
Motor activity, behavioral changes, coordination, sensory/motor reflex
responses and body temperature should be evaluated. For example, a
functional observation battery (FOB) modified Irwin’s or other appropriate
test can be used.
Central Nervous System:
18
19. Effects of the test substance on the cardiovascular system
should be assessed appropriately.
Blood pressure, heart rate, and the electrocardiogram should
be evaluated.
Cardiovascular System
19
20. Effects of the test substance on the respiratory system should be
assessed appropriately.
Respiratory rate and other measures of respiratory function (e.g., tidal
volume or hemoglobin oxygen saturation) should be evaluated.
Respiratory System
20
21. Adverse effects may be suspected based on the pharmacological properties or
chemical class of the test substance.
Additionally, concerns may arise from the safety pharmacology core battery,
clinical trials, pharmacovigilance, experimental in vitro or in vivo studies, or
from literature reports. When such potential adverse effects raise concern for
human safety, these should be explored in follow-up or supplemental safety
pharmacology studies.
2.7 Follow-up Studies For Safety Pharmacology Core Battery
21
22. Behavioral pharmacology
Learning and memory
Ligand-specific binding
Neurochemistry
Electrophysiology examinations, etc.
Central Nervous System:
22
23. Cardiac output
Ventricular contractility
Vascular resistance
The effects of endogenous and/or exogenous substances on the
cardiovascular responses, etc.
Cardiovascular System
23
25. Supplemental studies are meant to evaluate potential adverse
pharmacodynamic effects on organ system functions not addressed by
the core battery or repeated dose toxicity studies when there is a cause
for concern.
Supplemental Safety Pharmacology Studies
25
26. 26
Effects of the test substance on renal parameters should be assessed. For
example, urinary volume, specific gravity, osmolality, pH,
fluid/electrolyte balance, proteins, cytology, and blood chemistry
determinations such as blood urea nitrogen, creatinine and plasma
proteins can be used.
Renal/Urinary System
27. Autonomic Nervous System:
• Effects of the test substance on the autonomic nervous system should
be assessed. For example, binding to receptors relevant for the
autonomic nervous system, functional responses to agonists or
antagonists in vivo or in vitro, direct stimulation of autonomic nerves
and measurement of cardiovascular responses, baroreflex testing, and
heart rate variability can be used.
27
28. Gastrointestinal System
Effects of the test substance on the gastrointestinal system should be
assessed. For example, gastric secretion, gastrointestinal injury
potential, bile secretion, transit time in vivo, gastric pH measurement
and pooling can be used.
28
29. Conditions under which Studies are not Necessary
Safety pharmacology studies may not be needed for locally applied
agents (e.g., dermal or ocular)
For biotechnology-derived products that achieve highly specific
receptor targeting, it is often sufficient to evaluate safety
pharmacology endpoints as a part of toxicology and pharmacodynamic
studies, and therefore safety pharmacology studies can be reduced or
eliminated for these products.
29
30. Application of GLP:
NOT GLP
-Primary PD Studies
-Secondary PD when not pivotal to safety
Ordinarily GLP
-Core battery
-SP endpoints from toxicology studies
-Secondary PD studies when pivotal
GLP to the greatest extent feasible
-Supplemental, Follow-up
30
31. Reference:
• ICH Harmonized Tripartite Guideline(S7A) “ Safety Pharmacology
Studies For Human Pharmaceuticals”(2000)
31