What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Analytical method validation, ICH Q2 guidelineAbhishek Soni
Analytical Method Validation, ICH Q2 Guideline.
General principles related to the analytical method validation.
Validation of analytical method as per International Council for Harmonisation(ICH) guidelines and the United States Pharmacopeia(USP).
Glossary.
Useful in understanding the terms :
Specificity
Linearity
Range
Accuracy
Precision
Detection limit
Quantitation limit
Robustness
Ruggedness
System suitability testing
2 Aspects of compatibility tests are:
Identification of compatible excipients for a formulation.
Identification of stable storage conditions
2 Types:
Solid state reactions: much slower and difficult to interpret.
Liquid state reactions: easier to detect
According to Stability Guidelines by FDA following conditions should be evaluated for solutions or suspensions
1. Acidic or alkaline pH.
2. Presence of added substances
3. High oxygen and nitrogen atmospheres.
4. Effect of stress testing conditions.
ICH Stability testing of new drug substances and products QA (R2) - 2015
Almudena Camacho
Mohammad Koosha
Rocio Monroy
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
Analytical method validation, ICH Q2 guidelineAbhishek Soni
Analytical Method Validation, ICH Q2 Guideline.
General principles related to the analytical method validation.
Validation of analytical method as per International Council for Harmonisation(ICH) guidelines and the United States Pharmacopeia(USP).
Glossary.
Useful in understanding the terms :
Specificity
Linearity
Range
Accuracy
Precision
Detection limit
Quantitation limit
Robustness
Ruggedness
System suitability testing
2 Aspects of compatibility tests are:
Identification of compatible excipients for a formulation.
Identification of stable storage conditions
2 Types:
Solid state reactions: much slower and difficult to interpret.
Liquid state reactions: easier to detect
According to Stability Guidelines by FDA following conditions should be evaluated for solutions or suspensions
1. Acidic or alkaline pH.
2. Presence of added substances
3. High oxygen and nitrogen atmospheres.
4. Effect of stress testing conditions.
ICH Stability testing of new drug substances and products QA (R2) - 2015
Almudena Camacho
Mohammad Koosha
Rocio Monroy
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
The presentation will give an insight into ICH Q1A Stability testing of New drug products. Here the ppt is much focused on stability requirements for ANDA, no: of batches, storage conditions, testing frequency.
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
Quality Safety Efficacy Multidisciplinary (Q S E M)
ICH Q1 Stability
Case toxicity of ethylene glycol and diethylene glycol in cough syrup.
accelerated stability studies
constant interval method
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.
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!
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.
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
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
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.
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.
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
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.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
2. Introduction
Objective
Scope
General Principle
Guidelines
Drug Substance
Drug Product
Reference
2
Flow of Presentation
3/30/2022
3. Introduction
3
• ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and
Products
• Defines the stability data package for a new drug substance or drug
product that is sufficient for a registration application within the three
regions of the EC, Japan, and the United States.
• It does not seek necessarily to cover the testing for registration in or
export to other areas of the world.
• The purpose of 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, and to establish a re-test period for the drug substance or a shelf
life for the drug product and recommended storage conditions.
3/30/2022
4. Objective:
• Defines the stability data package for a new drug substance (API) or
drug product (Finished Product) for a registration application within
the three regions,
I. European Commission
II. Japan
III. United States.
Scope:
• Addresses the information to be submitted in registration applications
for new molecular entities and associated drug products.
4
Introduction (cont.)
3/30/2022
5. General Principle:
• 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.
• To establish shelf life of the drug product
• Determine recommended storage conditions.
5
Introduction (cont.)
3/30/2022
6. Stability studies at all stages of the
drug product life cycle
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6
Early stage
stress and
accelerated
testing with
drug
substances
Stage
1
•Stability on
pre
formulatio
n batches
Stage
2
Stress
testing on
scale up
batches
Stage
3
Accelerated
and long
term testing
for
registration
purpose
Stage
4
Ongoing
stability
testing
Stage
5
Follow up
stabilities
Stage
6
7. Drug Substance:
General: Stability of the drug substance is an integral part of the
systematic approach to stability evaluation.
Stress Testing: helps to determine the intrinsic stability of the molecule
I. To identify the degradation product.
II. To establish the degradation pathways.
III. To validate the stability indicating power of the analytical method.
• It is carried out on a single batch of the drug substance.
7
Guideline
3/30/2022
8. Selection of Batches : Data should be provided on at least three
primary batches.
• The batches should be manufactured to a minimum of pilot scale
batches by the same method of manufacture and procedure whichis
used for the final product.
Container Closure System : 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.
Specification : Include
I. List of tests
II. Reference to analytical procedures
III. Proposed acceptance criteria
Guideline (cont.)
8
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8
9. Testing Frequency and Storage Conditions :
* It is up to the applicant to decide whether long term stability studies are performed at 25 ± 2°C/60% RH ±5%
RH or 30°C ±2°C/65% RH ± 5% RH.
** If 30°C ±2°C/65% RH ± 5% RH is the long-term condition, there is no intermediatecondition.
Guideline (cont.)
Type of Study
in General Case
Storage Condition Testing Frequency Minimum time
period
covered by data at
submission
Long term* 25°C ± 2°C/60% RH ± 5% RH
or
30°C ± 2°C/65% RH ± 5% RH
1st Year: Every 3 months
2nd Year: Every 6 months
Subsequent Years: annually
12 months
Accelerated 40°C ± 2°C/75% RH ± 5% RH 0, 3, 6 Months 6 months
Intermediate** 30°C ± 2°C/65% RH ± 5% RH 0, 6, 9, 12 Months 6 months
9
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9
10. Intermediate storage condition should be done, when significant
change* occurs in accelerated storage condition.
*significant change failure to meet its specification.
Guideline (cont.)
10
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11. Drug substances intended for storage in a Refrigerator:
11
Drug substances intended for storage in a Freezer:
Guideline (cont.)
Type of Study Storage Condition Minimum time period
covered by data at
submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months
Type of Study Storage Condition Minimum time period
covered by data at
submission
Long term -20°C ± 5°C 12 months
3/30/2022
12. Drug substances intended for storage below -20°C: should be treated
on a case-by-case basis.
Stability Commitment: When available long term stability data do not
cover the proposed re-test period, a commitment should be made to
continue the stability studies to firmly establish the re-test period.
• If the submission data on fewer than three production batches, a
commitment should be made to continue these studies through the
proposed re-test period and to place additional production batches, to
a total of at least three.
• 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 re-test period.
Guideline (cont.)
12
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1
2
13. Evaluation: The purpose of the stability study is to evaluating the
stability information.
Statements/Labeling: A storage statement should be established for
the labeling in accordance with relevant national/regional
requirements.
• based on the stability evaluation of the drug substance
• Where applicable, specific instructions should be provided.
13
Guideline (cont.)
3/30/2022
14. Drug Product:
General: The design of the formal stability studies for the drug product
should be based on knowledge of the behavior and properties of the
drug substance.
Photostability Testing: Photostability testing should be conducted on
at least one primary batch of the drug product.
• The standard conditions for photostability testing are described in ICH
Q1B guideline in detail.
14
Guideline (cont.)
3/30/2022
15. Selection of Batches: Data from stability studies should be provided on
at least three primary batches of the drug product.
• Batches should be of the same formulation and packaged in the same
container closure system as proposed for marketing.
• Two of the three batches should be at least pilot scale batches and the
third one can be smaller, if justified.
• Where possible, batches should be manufactured by using different
batches of the drug substance.
Container Closure System: Stability testing should be conducted on
container closure system proposed for marketing.
15
Guideline (cont.)
3/30/2022
16. Specification : Include
I. List of tests
II. Reference to analytical procedures
III. Proposed acceptance criteria
16
Guideline (cont.)
3/30/2022
17. Testing Frequency and Storage Conditions :
* It is up to the applicant to decide whether long term stability studies are performed at 25 ± 2°C/60% RH ±5%
RH or 30°C ±2°C/65% RH ±5% RH.
** If 30°C ±2°C/65% RH ± 5% RH is the long-term condition, there is no intermediatecondition.
Guideline (cont.)
Type of Studyin
General Case
Storage Condition Testing Frequency Minimum time
period
covered by data at
submission
Long term* 25°C ± 2°C/60% RH ± 5% RH
or
30°C ± 2°C/65% RH ± 5% RH
1st Year: Every 3 months
2nd Year: Every 6 months
Subsequent Years: annually
12 months
Accelerated 40°C ± 2°C/75% RH ± 5% RH 0, 3, 6 Months 6 months
Intermediate** 30°C ± 2°C/65% RH ± 5% RH 0, 6, 9, 12 Months 6 months
17
3/30/2022
1
7
18. Intermediate storage condition should be done, when significant
change* occurs in accelerated storage condition.
*significant change includes,
I. A 5% change in assay from its initial value
II. Any degradation product’s exceeding its acceptance criterion
III. Failure to meet the acceptance criteria for appearance, physical
attributes, and functionality test (e.g., color, phase separation,
resuspendibility, caking, hardness) however, some changes in physical
attributes (e.g., softening of suppositories, melting of creams) may be
expected under accelerated conditions.
IV. Failure to meet the acceptance criterion for pH
V. Failure to meet the acceptance criteria for dissolution for 12 dosage
units.
Guideline (cont.)
18
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1
8
19. Drug products packaged in impermeable containers : Provides a
permanent barrier to passage of moisture or solvent and it can be
conducted under any controlled or ambient humidity condition.
Guideline (cont.)
19
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1
9
20. Drug products packaged in semi-permeable containers : Aqueous-
based products packaged in semi-permeable containers should be
evaluated for potential water loss in addition to physical,
chemical, biological and microbiological stability.
*It is up to the applicant to decide whether long term stability studies are performed at 25 ± 2°C/40% RH ± 5%
RH or 30°C ± 2°C/35% RH ± 5% RH.
**If 30°C ± 2°C/35% RH ± 5% RH is the long-term condition, there is no intermediate condition.
Guideline (cont.)
Type of Study Storage Condition Minimum timeperiod
covered by data at
submission
Long term* 25°C ± 2°C/40% RH ± 5% RH
or
30°C ± 2°C/35% RH ± 5% RH
12 months
Intermediate** 30°C ± 2°C/65% RH ± 5% RH 6 months
Accelerated 40°C ± 2°C/NMT 25% RH 6 Months
20
3/30/2022
2
0
21. A 5% waterloss from its initial value is considered as a significant
change after 3 months of storage at 40°C/NMT 25% RH.
However, for small containers (1 mL or less) or unit dose products, it
may be appropriate, if justified.
21
Guideline (cont.)
Reference
relative
humidity
Alternative relative
humidity
Ratio of water loss ata
given temperature
Calculation
25% RH 60% RH 1.9 (100-25) / (100-60)
40% RH 60% RH 1.5 (100-40) / (100-60)
35% RH 65% RH 1.9 (100-35) / (100-65)
25% RH 75% RH 3.0 (100-25) / (100-75)
3/30/2022
22. Drug products intended for storage in a Refrigerator:
22
Drug products intended for storage in a Freezer:
Guideline (cont.)
Type of Study Storage Condition Minimum time period
covered by data at
submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months
Type of Study Storage Condition Minimum time period
covered by data at
submission
Long term -20°C ± 5°C 12 months
3/30/2022
23. Drug products intended for storage below -20°C: should be treated on
a case-by-case basis.
Stability Commitment: When available long term stability data do not
cover the proposed shelf life period, a commitment should be made to
continue the stability studies to firmly establish the shelf life period.
• If the submission data on fewer than three production batches, a
commitment should be made to continue these studies through the
proposed shelf life period and to place additional production batches,
to a total of at least three.
• 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 shelf life period.
Guideline (cont.)
23
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2
3
24. Evaluation: The purpose of the stability study is to evaluating the
stability information.
Statements/Labeling: A storage statement should be established for
the labeling in accordance with relevant national/regional
requirements.
• based on the stability evaluation of the drug product
• Where applicable, specific instructions should be provided.
24
Guideline (cont.)
3/30/2022
25. International conference on harmonisation of technical requirements
for registration of pharmaceuticals for human use , “Stability testing of
New drug substances and products Q1A(R2)” 6 February 2003
25
Reference
3/30/2022