Stability testing is used to provide evidence of how the quality of a drug substance or product varies over time under environmental conditions like temperature, humidity, and light. Guidelines provide recommendations on conducting stability tests including storing samples under long-term, intermediate, and accelerated conditions and specifying the testing frequency. Stability tests evaluate attributes of the drug substance or product that may change during storage. The results are used to establish a retest period to ensure the stated quality of the substance or product through the expiration date.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
Analytical method validation as per ich and usp shreyas B R
Analytical method validation is a process of documenting/ proving that an analytical method provides analytical data acceptable for the intended use.After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredient (APIs) & finished pharmaceutical protocols (FPPs), replacing the previous WHO guidelines in this area. However, alternative approaches can be used when they are scientifically justified. Further guidelines can be found in International Conference on Harmonisation (ICH) guidelines and in the who guidelines on the active pharmaceutical ingredient master file procedure.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
WHO Guideline & Stability Protocols for Liquid Dosage FormsAnindya Jana
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredient (APIs) & finished pharmaceutical protocols (FPPs), replacing the previous WHO guidelines in this area. However, alternative approaches can be used when they are scientifically justified. Further guidelines can be found in International Conference on Harmonisation (ICH) guidelines and in the who guidelines on the active pharmaceutical ingredient master file procedure.
ICH Guideline Stability Testing of New Drug Substances and Product Q1A(R2).pptxTrishala Bhatt
This presentation outlines the ICH Guideline for Stability Testing of New Drug Substances and Products, Q1A(R2). It serves as a comprehensive framework for ensuring the stability of new pharmaceuticals, with a focus on the requirements for registration applications within the EC, Japan, and the United States. The guideline emphasizes a balance between a standardized approach and the flexibility to adapt to specific scientific considerations and characteristics of the materials under evaluation.
ICH guidelines for stability studies of different formulation and active pharmaceuticals.
physical, chemical, microbial, toxicological therapeutic stability studies.
accelerated and intermediate, long term stability studies
by following the stability studies we can predict the expiry period and half life of product and avoid the toxic effect of the unstable product
ICH STABILITY TESTING GUIDELINES (ICH Q1A-Q1F).pptxDurgadevi Ganesan
ICH Stability Testing Guidelines: ICH Q1A-Q1F (Q1 series)
Q1A(R2): STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1B: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1C: STABILITY TESTING FOR NEW DOSAGE FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
Q1E: EVALUATION OF STABILITY DATA
Q1F: STABILITY DATA PACKAGE FOR REGISTRATION APPLICATIONS IN CLIMATIC ZONES III & IV
introduction
mechanisms of protein drug binding
binding of drugs
binding of drugs to blood components
determination of protein drug binding
factors affecting
significance
Introduction
working principle
fragmentation process
general rules for fragmentation
general modes of fragmentation
metastable ions
isotopic peaks
applications
POTENTIAL SOURCES OF ELEMENTAL IMPURITIESMehulJain143
INTRODUCTION
INDENTIFICATION OF POTENTIAL ELEMENTAL IMPURITIES
FACTORS AFFECTING
EVALUATION
RISK ASSESSMENT AND CONTROL OF ELEMENTAL IMPURITIES
GENERAL PRINCIPLES
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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 prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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.
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
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
2. DRUG STABILITY
DEFINITION:
A measure of how pharmaceutical products maintains its quality attribute over a
time period.
3. TYPES OF STABILITY
CHEMICAL: Each active ingredient retains its chemical integrity and
labeled potency within the specified limit.
PHYSICAL: The physical stability properties includes appearance,
palatability, uniformity, dissolution and suspend ability are retained.
MICROBIOLOGICAL: Sterility or resistance to microbial growth is
retained according to specified requirement.
THERAPEUTIC: Therapeutic activity remains unchanged.
TOXCOLOGICAL: No significant increase in toxicity occurs.
4. ICH GUIDELINES
ICH GUIDELINES TITLE
Q1 A Stability testing of new drug substances
and products
Q1 B Stability testing: photo stability testing
of new drug substance and products
Q1 C Stability testing for new dsage forms
Q1 D Bracketing and matrixing designs for
stability testing of drug substances and
products
Q1 E Evaluation of stability data
Q1 F Stability data package for registation
application in climatic zones Ш and IV
5. What is meant by stability testing?
Stability testing is utilized to determine if the quality of a drug substance or drug
product is altered over time by various environmental factors, such as light, temperature
and humidity.
6. INTRODUCTION
This guidance is the second revision of Q1A Stability Testing of New Drug Substances
and Products, which was first published in September 1994 and revised in August
2001.
The purpose of this revision is to harmonize the intermediate storage condition for
zones I and II with the long-term condition for zones III and IV recommended in the
ICH guidance.
7. Objectives of the Stability testing
Stability testing is to provide evidence on how the quality of a drug substance or
drug product varies with time under the influence of a variety of environmental
factors such as temperature, humidity, and light.
8. STABILITY TESTING OF API’S
1. General
2. Stress testing
3. Selection of batches
4. Container closure system
5. Specifications
6. Testing frequency
7. Storage conditions
8. Stability commitment
9. Evaluation
10. Statements/labeling
9. 1. GENERAL
Information on the stability of the drug substance is an integral part of the systematic
approach to stability evaluation.
10. 2. STRESS TESTING
Stress testing of the drug substance can help identify the likely degradation products,
which can in turn help establish the degradation pathways.
validate the stability indicating power of the analytical procedures used.
Stress testing is likely to be carried out on a single batch of the drug substance.
The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C,
60°C) above that for accelerated testing), humidity (e.g.,75 percent relative humidity or
greater) where appropriate, oxidation, and photolysis on the drug substance.
11. 3. SELECTION OF BATCHES
Data from formal stability studies should be
provided on at least three primary batches of the
drug substance.
The batches should be manufactured to a minimum
of pilot scale by the same synthetic route as
production batches and using a method of
manufacture and procedure that simulates the final
process to be used for production batches.
12. 4. CONTAINER CLOSURE SYSTEM
The stability studies should be conducted on the drug substance
packaged in a container closure system that is the same as or
simulates the packaging proposed for storage and distribution.
13. 5. SPECIFICATION
Stability studies should include testing of those attributes of the drug substance that are
susceptible to change during storage and are likely to influence quality, safety and
efficacy.
The testing should cover as appropriate the physical, chemical, biological and
microbiological attributes.
Eg. Appearance, assay, degradation.
14. 6. TESTING FREQUENCY
For long term stability studies:
year 1: every 3 months
year 2: every 6 months
subsequent years: annually
At accelerated storage conditions: (6 months study)
minimum three points including t0 and t final
Eg. 0(initial) 3 6(final)
At intermediate storage conditions: (12 months study)
four points including t0 to t final
Eg. 0(initial) 6 9 12(final)
15. 7. STORAGE CONDITIONS
In general, a drug substance should be evaluated under storage conditions (with
appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity
to moisture.
GENERAL CASE:
GENERAL CASE:
STUDY STORAGE CONDITIONS MINIMUM TIME PERIOD
COVERED BY DATAAT
SUBMISSSION
LONG TERM
(AMBIENT)
250 C ± 20C
60% RH ± 5% RH
12 MONTHS
INTERMEDIATE
(CONTROLLED)
300 C ± 20C
65% RH ± 5%
6 MONTHS
ACCELERATED 400 C ± 20C
75% RH ± 5%
6 MONTHS
16. STORAGE IN REFRIGERATOR:
STORAGE IN FREEZER:
STUDY STORAGE CONDITIONS MINIMUM TIME PERIOD
COVERED BY DATAAT
SUBMISSION
LONG TERM 50C ± 30C 12 MONTHS
ACCELERATED 250C ± 20C
60% RH ± 5%
6 MONTHS
STUDY STORAGE CONDITIONS MINIMUM TIME PERIOD
COVERED BY DATAAT
SUBMISSION
LONG TERM -200C±50C 12 MONTHS
17. 8. STABILITY COMMITMENT
When available long-term stability data on primary batches do not cover the proposed
retest period granted at the time of approval, a commitment should be made to continue
the stability studies post approval to firmly establish the retest period.
If the submission includes data from stability studies on at least three production
batches, a commitment should be made to continue these studies through the proposed
retest period.
If the submission includes data from stability studies on fewer than three production
batches, a commitment should be made to continue these studies through the proposed
retest period and to place additional production batches, to a total of at least three, on
long-term stability studies through the proposed retest period.
If the submission does not include stability data on production batches, a commitment
should be made to place the first three production batches on long term stability studies
through the proposed retest period.
18. 9. EVALUATION
Based on testing a minimum of three batches of the drug substance.
Evaluating the stability information (including, as appropriate, results of the physical,
chemical, biological, and microbiological tests).
The degree of variability of individual batches affects the confidence that a future
production batch will remain within specification throughout the assigned retest period.
If analysis shows that the batch-to-batch variability is small, it is advantageous to
combine the data into one overall estimate.
Any evaluation should cover not only the assay, but also the levels of degradation
products and other appropriate attributes.
19. 10. STATEMENT /LABELING
A storage statement should be established for the labeling in accordance with relevant
national/regional requirements.
The statement should be based on the stability evaluation of the drug substance.
Where applicable, specific instructions should be provided, particularly for drug
substances that cannot tolerate freezing.
A retest period should be derived from the stability information, and a retest date should
be displayed on the container label if appropriate.