ICH stability guidances provide guidance for new drug substances and drug products .CDER now wishes to apply these recommendations to ANDAs. Specific recommendations were given in FDA “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products. Recently FDA issued “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers.
Drug Regulations has prepared a presentation on ANDA stability requirements.
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
This presentation will address Refuse to Receive standards when Submitting ANDAs and Prior approval supplements (PASs) to ANDAs. The presentation highlights deficiencies that may cause FDA to refuse-to-receive an ANDA.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
This presentation will address Refuse to Receive standards when Submitting ANDAs and Prior approval supplements (PASs) to ANDAs. The presentation highlights deficiencies that may cause FDA to refuse-to-receive an ANDA.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
Comparison of stability testing requirements of ich with otherJun Brown
Stability plays an important role in the drug development process. Present work aims to compare the stability
testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory
agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and
European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability
testing requirements for new drug substance and drug product. WHO guidelines describe stability testing
requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information
to be submitted in original and subsequent applications for marketing authorization of their related Finished
pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters
like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term
storage condition (general case) and accelerated storage conditions (substance/product intended to be stored
in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along
with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and
real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on
stability testing requirements for new active substance and related products. It sets out the stability testing
requirements for existing active substance and related finished product. The minimum time period to be covered
by data at the time of submission during long term storage conditions differs from ICH guidelines.
The dissolution test is an important means of assuring the continuing performance of non-solution orally administered drug products. The development of a dissolution test procedure is briefly discussed in USP general information chapter In Vitro and In Vivo Evaluation of Dosage Forms 1088, whereas general information chapter Validation of Compendial Procedures 1225 gives limited validation information for dissolution testing. Neither of these two chapters provides a level of detail and focus sufficient for dissolution testing. In 2001, a Stimuli article provided an initial rationale and discussion of content for a new general information chapter. The new chapter, The Dissolution Procedure: Development and Validation 1092, was intended to supplement the information in 1088 and 1225 and provided step-by-step detail for development and validation as well as offering information on new technology and equipment. In 2006, the chapter became official with the Second Supplement to USP 29–NF 24 (2–4).
The General Chapters—Dosage Forms Expert Committee 2010–2015 placed the review and possible revision of The Dissolution Procedure: Development and Validation 1092 on its work plan for the 2010–2015 revision cycle (2011) .
Drug Regulations has prepared this presentation based on the proposed chapter.
This presentation is compiled by “ Drug Regulations” from freely available resources like the FDA on the World wide web.
“Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. So far this concept has been mainly applied to sterility testing of terminally sterilised products and has become associated with parametric release applications. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT).
RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
This presentation describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
In March 2011, the EMA and FDA launched a pilot program that aims at a parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD). This voluntary pilot program is open. This presentation gives a summary of the FDA and EMA expectation for QbD submissions based on the pilot programme.
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Phụ lục 3. Các chế định trong việc đánh giá sản phẩm sinh học trị liệu có nguồn gốc DNA tái tổ hợp. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
FDA Process Validation Guidance (Guidance for Industry: Process Validation- General Principles and Practices, Jan. 2011) outlines process validation activities in three stages - Stage 1: Process Design, Stage 2: Process Qualification and Stage 3: Continued Process Verification. Completion of Stage 2 subsequent to Stage 1 is a major milestone in the Process Validation Lifecycle as it confirms the process design and demonstrates the expected consistent performance of the manufacturing process. Knowledge and information gained from the design stage through the process qualification stage is used to complete this assessment. Stage 2 demonstrates suitability for successful commercial distribution where the data indicates that the process meets the conditions established in the protocol. Continued Process Verification is initiated for the subsequent commercial batches. Stage 3 assures that the process remains in a state of control during commercial manufacture.
This presentation gives a practical approach to implement the stage 3 of the FDA Process Validation Guide.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Confederation of indian industry recommendations for guideline changes in the...Dr. Rajesh Jain
Confederation of indian industry recommendations for Guideline Changes in the Vaccine approval procedures to the ministry of health & family welfare
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
Drug Regulations is a Not for Profit Organizations which provides free online resources for the Pharmaceutical Professional. This presentation is part H of series of presentations which addresses the current Good Manufacturing Requirements as per the US FDA. This presentation addresses : : Laboratory Ccntrols
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
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.
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.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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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
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
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
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.
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
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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
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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.
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.
1. This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
4/16/2014 1
2. This presentation is compiled from freely available
resources like the website of FDA specifically
“Guidance for Industry
ANDAs: Stability Testing of Drug Substances and
Products”
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
4/16/2014 2
Drug Regulations : Online
Resource for Latest Information
3. The following existing ICH guidances address stability for
new drug substances and products:
◦ Q1A (R2) Stability Testing of New Drug Substances and Products.
◦ Q1B Photo stability 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
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4. ICH stability guidances provide guidance for
new drug substances and drug products
CDER now wishes to apply these
recommendations to ANDAs.
Specific recommendations are given in
subsequent slide
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5. 1. Submit data from three pilot scale batches
or two pilot scale batches and one small
scale batch.
◦ If the size of the pilot scale batch does not follow
ICH recommendations, the applicant should
provide a justification.
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6. 2. At the time of submission, provide 6
months of data that include accelerated and
long-term conditions.
◦ FDA recommends following ICH guidelines with
respect to utilization of intermediate conditions to
support shelf-life.
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7. 3. Use multiple lots of drug substance as appropriate.
4. Manufacture and package the drug product using principles
that are representative of the commercial process.
5. Provide a fully packaged primary batch.
6. Use drug product from all three primary batches when using
bracketing and matrixing designs under ICH Q1D.
7. Provide statistical analysis of the data as appropriate, in
accordance with ICH Q1E, Appendix A.
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8. The stability guidance covers all new ANDAs under the
Federal Food, Drug, and Cosmetic Act, section 505 (j)
DMFs (Type II for drug substances that support the
ANDAs).
It does not apply to postapproval changes
The final guidance availability will be announced in the
Federal Register.
The implementation date is June 20, 2014.
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9. For chemistry, manufacturing, and controls
(CMC) information, PEPFAR ANDAs should
follow
◦ The guidance for industry on Fixed Dose
Combinations, Co-Packaged Drug Products, and
◦ Single-Entity Versions of Previously Approved
Antiretrovirals for the Treatment of HIV.
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10. A minimum of three batches at or near the upper end of the
proposed radio-concentration.
If different synthesizers (methods of synthesis) are used, three
batches from each method of synthesis at or near the upper end
of the proposed radio-concentration are recommended.
Batches do not have to be made in the same facility.
For the additional manufacturing facilities, applicants should
provide stability data on at least one batch from each facility,
although bracketing approaches could be submitted for review.
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11. Stability data expectation at the time of ANDA
submission is
◦ 6 months of accelerated and
◦ 6 months of long-term data.
◦ However, if 6 months accelerated data show significant
change or failure of any attribute, 6 months of
intermediate data are also recommended at the time of
submission.
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12. Start intermediate stability, accelerated, and
long-term studies at the same time so the
data are available at the time of submission,
if needed.
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13. In the event accelerated data show significant
change or failure of any attribute in one or
more batches, intermediate data is
recommended for all three batches.
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14. Stability bracketing and/or matrixing can be used to
determine the configurations to be placed on stability
for an original ANDA without prior approval from the
Office of Generic Drugs (OGD)
Follow the International Conference on Harmonisation
(ICH) guidance for industry on Q1D Bracketing and
Matrixing Designs for Stability Testing of New Drug
Substances and Products and its example tables.
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15. FDA will grant a proposed expiry period of two times the
available long-term data at the time of approval (up to 24
months)
◦ As per ICH Q1E Evaluation of Stability Data (ICH Q1E) guidance
◦ Provided the submitted data are satisfactory, and
◦ Data evaluation is provided in accordance with ICH Q1E
Please refer to the decision tree (Appendix A) in ICH Q1E.
The ANDA should be updated with 12 months of long-
term data.
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16. Follow the recommendations in the stability guidance
where three pilot scale batches or two pilot scale
batches and one small scale batch are recommended.
This applies to all dosage forms.
Only two lots of finished product at pilot scale batch
size will not be sufficient to support the stability of
an ANDA for simple dosage forms
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17. ICH Q1E principles will help in the calculation of expiration dating.
Data from the three ANDA submission batches (i.e., 6 months),
accelerated data meeting all criteria (without significant change per ICH
Q1A(R2)), and 12 months long-term data without variability will not
need statistical evaluation.
Stability data from three ANDA submission batches at 12 months long-
term are recommended for 24-month extrapolation.
If there is a significant change in the accelerated data, ICH Q1E,
Appendix A, provides more detail regarding when intermediate
condition stability data are recommended.
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18. ICH stability guidances should be followed regardless
of patent status;
6 months of accelerated & Long term data are
recommended at the time of filing the ANDA.
If a patent is due to expire shortly and there are no
approved ANDAs, one can not file with 3 months
stability data with a commitment to supply 6 months
data when available.
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19. Sample storage times are discussed in 21 CFR 320.38 and 21 CFR
320.63 for bioequivalence-study-samples when the pilot scale batch is
used in the bioequivalence study or studies.
The guidance for industry on Handling and Retention of BA and BE
Testing Samples may be helpful.
ANDA submission batch samples should be stored for 1 year after
approval of the ANDA, and
Samples of the drug product used for bioequivalence studies should be
stored following requirements listed in the CFR citations and
recommendations in the guidance listed above.
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20. ICH Q1A(R2) recommends three primary batches (at least of the pilot
scale size) for the drug substance filed in the DMF.
These batches should be made under Current Good Manufacturing
Practices (CGMP).
The stability guidance recommends a minimum of 6 months of
accelerated and 6 months of long-term data for the pilot scale batches
to be submitted initially.
Additional long-term data for all three batches, as the data becomes
available through the proposed retest period, should be submitted as an
amendment.
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21. (see the draft guidance for industry on Initial Completeness
Assessments for Type II API DMFs under GDUFA)
To pass the Completeness Assessment DMFs should have the
◦ Stability protocol,
◦ Commitments, and
◦ Data demonstrating that stability studies have started.
The initial and one additional time point for the accelerated
studies and long-term studies are sufficient.
The DMF holder should amend the DMF with updated stability
data to prepare for the full scientific review, if the DMF does not
meet the recommendations given in earlier slide at the time of
the Completeness Assessment.
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22. Submissions to DMFs will be accepted based on
stability data from production scale batches
Per ICH Q1A(R2), section II, A, 8, Stability
Commitment (2.1.8), the submission is appropriate if
satisfactory stability data from three production
batches made under CGMP are filed in the DMF with 6
months of accelerated data and long-term data
covering the proposed retest period.
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23. Split bulk solution filled into different fill
volumes will not be considered different
batches
Split filling one batch of bulk solution into
different fill volume sizes does not constitute
discrete batches.
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24. Blow-fill-seal containers are not an exception from regular packaging
Are usually packaged inside a secondary container or a carton.
The secondary packaging should be included in all three batches.
ICH Q1A(R2) addresses secondary packaging usefulness (see section II,
B, 4, Drug Product Container Closure System (2.2.4)).
All three batches should be stored in final proposed packaging
◦ Pack all three batches in the container closure system proposed for marketing.
Q1A(R2) addresses this question (see section II, B, 4, Drug Product
Container Closure System (2.2.4)).
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25. A minimum of two lots of the drug substance
should be used to prepare the three primary
batches of drug product.
It is not necessary to use different lots of
packaging material, except in cases where the
packaging material could affect drug product
performance and/or delivery.
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26. Small scale batches should be packaged with commercial
equipment.
Packaging systems used should be the same as or similar
to packaging proposed for storage and market
distribution.
Please refer to ICH Q1A(R2) section II, B, 3, Selection of
Batches (2.2.3) and the glossary definition for primary
batches.
Follow ICH Q1A(R2) section II, B, 4, Drug Product Container
Closure System (2.2.4).
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27. Follow the guidance for data on three batches
per ICH Q1A(R2).
ICH stability guidances do not distinguish
among different dosage forms.
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28. For other dosage forms like
◦ Oral solutions,
◦ Ophthalmic solutions,
◦ Oral and ophthalmic suspensions,
◦ Transdermal patches,
◦ Ointments,
◦ Creams,
◦ Granules for reconstitution, and
◦ Parenterals
Follow ICH Q1A(R2)
Submit data of three discrete batches and 6 months of accelerated and
long-term data at the time of submission for all dosage forms
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29. As per ICH stability guidances, 6 months
(accelerated) stability is recommended on all
three submission batches.
One batch at 6 months and two lots at 3
months are not acceptable
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30. Include executed batch records for the three
batches in the ANDA submission
Include all relevant CMC batch information for
the three stability batches in the application
◦ (i.e., excipient Certificate of Analysis (COA))
When more than one lot of API or excipients is
used, the corresponding section in Module 3
should contain that information.
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31. For a second or more than two sources of API for
the same drug substance, provide following CMC
information:
◦ Comparison and justification of comparability (by the
firm) of the physico-chemical properties and impurities
of the drug substance from each source.
◦ Appropriate stability data on three batches of drug
product qualifying the first API source used in the
bioequivalence (BE) studies as recommended by the
stability guidance.
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32. For a second or more than two sources of API for the same
drug substance, provide following CMC information:
◦ A single pilot scale batch of the drug product bio-strength(s)
manufactured using the second or each of the other proposed API
source(s) used to support the ANDA application, along with
comparative dissolution data.
◦ Appropriate stability data (accelerated and long-term for 6
months at the time of filing) on the strength(s) manufactured for
each API source.
◦ Appropriate stability data may in some cases include intermediate
condition stability data.
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33. Unless specifically noted in subsequent
slides, one primary batch should be fully
packaged.
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34. (e.g., immediate release, extended release,
chewable, orally disintegrating and delayed
release tablets or capsules):
◦ Two of the three batches should be of at least 10
percent of the proposed production batch or 100,000
finished dosage units, whichever is greater (i.e., pilot
scale batches).
◦ The third batch can be smaller than the 10 percent of
the proposed production batch, but not less than 25
percent of the pilot scale batch.
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35. (e.g., immediate release, extended release, chewable, orally
disintegrating and delayed release tablets or capsules):
FDA recommends stability data be generated for the three ANDA
submission batches in the proposed marketing container.
A minimum of 100,000 units in all proposed presentations is
recommended.
Representative samples from all three batches must be packaged
in a sufficient number of proposed marketing presentations to
comply with 21 CFR 211.166(a)(1-5) and 211.166(b).
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36. Two of the three batches should be at least 10 percent of the
proposed maximum size commercial batch.
The third batch can be smaller than 10 percent of the proposed
commercial batch, but not less than 25 percent of the pilot scale
batch.
To capture variability introduced by packaging, the product from
all the batches should be used in the packaging process.
FDA recommends packaging representative samples from all
three batches of a sufficient number of proposed marketing
presentations to comply with 21 CFR 211.166(a)(1-5) and
211.166(b) .
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37. Solutions/Powders for Solutions (lyophilized
cakes)/Suspensions/Sterile Topicals (Ophthalmic and Otic
drug products):
Two of the three batches should be at least 10 percent of
the proposed maximum size commercial batch (i.e., pilot
scale size) or 50 L (per batch), whichever is larger.
The third batch can be smaller than 10 percent of the
proposed commercial batch, but not less than 25 percent
of the pilot scale batch.
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38. Solutions/Powders for Solutions (lyophilized
cakes)/Suspensions/Sterile Topicals (Ophthalmic and Otic drug
products):
To capture variability introduced by packaging, the product from
all the batches should be used in the packaging process.
Representative samples from all the three batches should be
packaged in a sufficient number of proposed marketing
presentations to comply with 21 CFR 211.166(a)(1-5) and
211.166(b).
FDA recommends manufacturing all the batches to meet sterility
requirements.
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39. Two of the three batch sizes for each strength should be at least
10 percent of the proposed commercial production batch or
25,000 units (for each strength), whichever is greater.
The third batch can be smaller than 10 percent of the proposed
commercial batch, but not less than 60 percent of the pilot scale
batch.
For transdermal matrix products, where different strengths are
identified by the transdermal patch size (surface area), to comply
with the three batch size recommendation, FDA recommends
providing data on patches manufactured using three distinct
matrix laminates at the time of submission.
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40. (Each laminate can be cut to support multiple
strengths in the application, where
applicable.)
FDA recommends to contact appropriate
review division if you are manufacturing
transdermal patches using other technologies
(e.g., reservoir).
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41. Include a representative sample from all three
batches using different components of
backing, adhesives, release liner, and other
critical excipients used in packaging a
sufficient number of proposed marketing
presentations to comply with 21 CFR
211.166(a)(1-5) and 211.166(b).
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42. (a) Creams/Lotions/Gels:
For nonsterile semi-solid dosage forms, the two pilot scale
batches should be at least 100 Kg or 10 percent of the
production batch, whichever is larger.
The third batch can be smaller than 10 percent of the proposed
commercial batch, but not less than 40 percent of the pilot scale
batch.
FDA recommends packaging representative samples from all the
three batches in a sufficient number of proposed marketing
presentations to comply with 21 CFR 211.166(a)(1-5) and
211.166(b) .
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43. (b) Inhalation Solutions/Nasal Sprays (nasal
nonmetered dose atomizer):
Please refer to the following guidances for
industry for information:
◦ Nasal Spray and Inhalation Solution, Suspension, and
Spray Drug Products – Chemistry, Manufacturing, and
Controls Documentation, and
◦ Bioavailability and Bioequivalence Studies for Nasal
Aerosols and Nasal Sprays for Local Action.
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44. CGMP requirements for ANDA submission are expected for the drug
substance and drug product.
Because the drug substance quality can affect the drug product stability,
the drug substance used for the ANDA batches (supporting the
application) should be of the same quality intended for the market
product.
FDA would consider data from the use of a different grade drug
substance for a product as supporting data.
This does not satisfy the submission batch recommendations.
It is not acceptable to use a technical grade of the drug substance for
the small scale batches or one of the two pilot scale batches of finished
product.
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45. All ANDA submission batches should be
made under CGMP
Small scale batches also need to be
manufactured in accordance with all CGMP
regulations
It is not acceptable to manufacture the small
scale batches in a research setting
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46. It is not acceptable to manufacture the small
scale batches in a research setting
The small scale batches need to meet the
same finished product specification as the
pilot scale batches
The specification should be the same for all
three ANDA submission batches
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47. For sterile products, it is not acceptable to
manufacture the small scale batches in a
nonsterile facility and allow variance from
sterility and particulate criteria
Batches should not be manufactured in a
nonsterile facility.
Sterility is a critical quality attribute (CQA) for
sterile products.
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48. Small scale batches need to be produced at the
proposed commercial site
The primary batch information submitted in the
application is used to support the proposed
commercial product manufacture.
Product batches produced at a different site than
the proposed commercial site would not be
considered as primary batches.
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49. For ANDAs that contain multiple strengths (that are
dose proportional), three separate intermediate bulk
granulations (or blends) should be manufactured.
One batch of bulk granulation (or blend) should be
used to manufacture all the strengths proposed.
The other two bulk granulations (or blends) can be
used to manufacture only the lowest and the highest
strengths, in addition to the strength used in BE
studies.
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50. Stability testing should still use all three batches
of drug product.
In cases where an intermediate bulk material is
identical between the various strengths (dose
proportional blends, bulk solutions, etc.), it is not
sufficient to perform stability on one lot of each
strength, when each strength is produced from a
separate intermediate bulk.
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51. The submission ANDA batches can have a smaller
size than the established pilot scale, according to the
ICH definition, when any one of the following
circumstances prevails:
◦ The reference listed drug product has an orphan drug
designation.
◦ Use of a controlled drug substance is based on a Drug
Enforcement Administration allocation.
◦ The test batch size is the same as the commercial batch
size with the commitment that a prior approval supplement
(PAS) will be provided when there is a scale-up.
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52. The three ANDA submission batches should
maintain the chosen formula based on product
development studies for components and
composition.
Scale-up and postapproval changes (SUPAC) level
one and two variations and changes are not
permitted among the three ANDA submission
batches for components and composition
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53. The stability guidance recommends analysis of
data in accordance with ICH Q1E, Appendix A.
The flowchart in that guidance provides clear
situations where analysis is normally
recommended or unnecessary.
In addition, ICH Q1E B.7 figures provide example
diagrams for assay and degradation products
They illustrate how plots should be generated for
the three batches using regression lines and
upper and lower confidence limits.
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54. All amendments submitted to pending ANDAs
after the effective date of the final stability
guidance will be held to the standards in
place at the time of the original ANDA
submission, unless there is a concern with
the submitted stability data.
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55. In general, FDA recommends four time points
(i.e., 0 (initial release), 3 months, 6 months,
and one additional time point) to the study
design for all ANDAs
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56. For primary batches of liquids, solutions,
semi-solids, and suspensions, the product
should be placed into both inverted (or
horizontal) position and upright (or vertical)
position.
For routine stability studies, the firm should
pick the worst case orientation for the study.
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57. Recommendations listed in Q1A(R2), section
II, B, 7, Storage Conditions (2.2.7) should be
followed for all three batches.
These studies should be performed when the
drug product is labeled for reconstitution or
dilution.
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58. Examples of semipermeable containers are
provided in the Q1A(R2) glossary.
The recommendations for stability
expectations for semipermeable containers
are detailed in ICH Q1A(R2) section II, B, 7, c.
Drug products packaged in semipermeable
containers (2.2.7.3).
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59. One of the primary batches of the drug product
should be tested for antimicrobial preservative
effectiveness (in addition to preservative content)
at the end of the proposed expiration dating
period.
The drug product specification should include a
test for preservative content, and this attribute
should be tested in all stability studies.
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60. Extraction/leachable studies are generally
one time studies;
If multiple types of containers/closures are
employed for packaging, then additional
studies could be recommended.
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61. ICH Q1A(R2), section II, B, 8, Stability
Commitment (2.2.8) addresses this question.
Section 2.1.8 provides information regarding
stability commitment for drug substances.
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62. This presentation was compiled from freely
available resources like the website of FDA
specifically “Guidance for Industry
ANDAs: Stability Testing of Drug Substances and
Products”
“Drug Regulations” is a non profit organization
which provides free online resource to the
Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
4/16/2014 62
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