알림
뒤로
알림 설정
뒤로
더보기
게시물 알림
내 글 반응
내가 작성한 게시물이나 댓글에 다른 사람이 댓글이나 답글을 작성하면 알려줍니다.
공지사항
사이트에서 보내는 중요한 공지를 실시간으로 알려줍니다.
Alarm
마이페이지
로그아웃
로그인이 필요합니다.
로그인
What we do
QBD-AI
ChatRegulatoryAI
TEST 01 - Dr.JH
TEST 02 - Dr.Daniel
E&L
Extractables and Leachables study
GOOD to know I
GOOD to know II
GOOD to know III
Seminar
WEBINAR
2019 KINTEX
2020 KINTEX
2021 KINTEX
2022 KINTEX
2023 KINTEX
2024 KINTEX
2023 ISPE 교육
2024 ISPE 교육
E&L case study
FDA 사례연구
MFDS 사레연구
Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
EXTRACTION TIME & TEMP
CHARACTERIZING THE EXTRACT
SUMMARY
Example Extractables Profiles—Materials Chara
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
SAMPLE PREPARATION
VALIDATION
LEACHABLES–EXTRACTABLES CORRELATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
Practices and Challenges
Risk Assessment
BPOG RA section
USP1665 RA section
PQRI
PQRI Guidance
PART III Best Practices for E&L Asseessment i
PART III-II Characterization
한국식약처고시
용기적합성평가(MFDS)
가이드라인
SUMMARY
USP 665
USP665 BRIEFING
USP1665
Ophthalmic Drug
Sterile Filter E&L - EU GMP Annex1
Medical Device
Contract Service
M4 : The Common Technical Document (CTD)
Genotoxic Impurity
Impurity
SERVICES
ICH Q3A
ICH Q3B
ICH Q3C
ICH Q3D
ICH M7
Protein Characterization
SERVICE
ICH Q6B
mAb Service
Particulate Matter
Contamination
Container Closure Integrity
Cleanning Validation
Nitrosamine
PFAS
Data integrity
Sanger Sequencing Service
Other Service
SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
자료실
AI 기반 질의응답
QBD_AI 사용법및요청사항
용기적합성
Saint Gobain
communication
Becton Dickinson
공지사항
Photo
SWISS
PARIS
생고뱅제품구매하기
About Us
인사말
Vision
Business Partner
Partnering and Contact
닫기
Quality by Design Inc.
What we do
QBD-AI
ChatRegulatoryAI
TEST 01 - Dr.JH
TEST 02 - Dr.Daniel
E&L
Extractables and Leachables study
GOOD to know I
GOOD to know II
GOOD to know III
Seminar
WEBINAR
2019 KINTEX
2020 KINTEX
2021 KINTEX
2022 KINTEX
2023 KINTEX
2024 KINTEX
2023 ISPE 교육
2024 ISPE 교육
E&L case study
FDA 사례연구
MFDS 사레연구
Medical Device 사례연구
USP 1663
BRIFING
PURPOSE
KEY TERMS
SCOPE
BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
EXTRACTION TIME & TEMP
CHARACTERIZING THE EXTRACT
SUMMARY
Example Extractables Profiles—Materials Chara
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
SAMPLE PREPARATION
VALIDATION
LEACHABLES–EXTRACTABLES CORRELATION
SIMULATION STUDYS
INORANIC LEACHABLES
USP 1664.1
INTRODUCTION
KEY TERMS
LEACHABLES ASSESSMENT
DOSAGE FORM TYPES
CONSIDERATIONS
ICH Q3E
Concept
Practices and Challenges
Risk Assessment
BPOG RA section
USP1665 RA section
PQRI
PQRI Guidance
PART III Best Practices for E&L Asseessment i
PART III-II Characterization
한국식약처고시
용기적합성평가(MFDS)
가이드라인
SUMMARY
USP 665
USP665 BRIEFING
USP1665
Ophthalmic Drug
Sterile Filter E&L - EU GMP Annex1
Medical Device
Contract Service
M4 : The Common Technical Document (CTD)
Genotoxic Impurity
Impurity
SERVICES
ICH Q3A
ICH Q3B
ICH Q3C
ICH Q3D
ICH M7
Protein Characterization
SERVICE
ICH Q6B
mAb Service
Particulate Matter
Contamination
Container Closure Integrity
Cleanning Validation
Nitrosamine
PFAS
Data integrity
Sanger Sequencing Service
Other Service
SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
자료실
AI 기반 질의응답
QBD_AI 사용법및요청사항
용기적합성
Saint Gobain
communication
Becton Dickinson
공지사항
Photo
SWISS
PARIS
생고뱅제품구매하기
About Us
인사말
Vision
Business Partner
Partnering and Contact
Quality by Design Inc.
site search
로그인
회원가입
장바구니
0
MENU
What we do
QBD-AI
E&L
Contract Service
SAINT-GOBAIN
자료실
생고뱅제품구매하기
About Us
Partnering and Contact
What we do
QBD-AI
ChatRegulatoryAI
TEST 01 - Dr.JH
TEST 02 - Dr.Daniel
E&L
Extractables and Leachables study
GOOD to know I
GOOD to know II
GOOD to know III
Seminar
E&L case study
USP 1663
USP 1664
USP 1664.1
ICH Q3E
Risk Assessment
PQRI
한국식약처고시
용기적합성평가(MFDS)
USP 665
USP1665
Ophthalmic Drug
Sterile Filter E&L - EU GMP Annex1
Medical Device
Contract Service
M4 : The Common Technical Document (CTD)
Genotoxic Impurity
Impurity
Protein Characterization
Particulate Matter
Contamination
Container Closure Integrity
Cleanning Validation
Nitrosamine
PFAS
Data integrity
Sanger Sequencing Service
Other Service
SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
Single-Use Assemblies
Bioprocess Bags
Bio-Simplex®
Final Fill Custom Assemblies
자료실
AI 기반 질의응답
QBD_AI 사용법및요청사항
용기적합성
Saint Gobain
communication
Becton Dickinson
공지사항
Photo
생고뱅제품구매하기
About Us
인사말
Vision
Business Partner
Partnering and Contact
MENU
Quality by Design Inc.
장바구니
0
site search
What we do
QBD-AI
E&L
Contract Service
SAINT-GOBAIN
자료실
생고뱅제품구매하기
About Us
Partnering and Contact
