ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

Các tài liệu đính kèm:

Q1A(R2)_STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Q1B_STABILITY TESTING – 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 FOR STABILITY DATA

Q1F_Explanatory Note on the Withdrawal of ICH Q1F for the ICH Website

Q2(R1)_VALIDATION OF ANALYTICAL PROCEDURES – TEXT AND METHODOLOGY

Q3A(R2)_IMPURITIES IN NEW DRUG SUBSTANCES

Q3B(R2)_IMPURITIES IN NEW DRUG PRODUCTS

Q3C(R4)_IMPURITIES – GUIDELINE FOR RESIDUAL SOLVENTS

Q4B ANNEX 1_RESIDUE ON IGNITION_SULPHATED ASH GENERAL CHAPTER

Q4B ANNEX 2_TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS GENERAL CHAPTER

Q4B ANNEX 3_TEST FOR PARTICULATE CONTAMINATION-SUB-VISIBLE PARTICLES GENERAL CHAPTER

Q4B ANNEX 4A_ MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS – MICROBIAL ENUMERATIONS TESTS GENERAL CHAPTER

Q4B ANNEX 4B_MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS – TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER

Q4B ANNEX 4C_PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS

Q4B ANNEX 5_DISINTEGRATION TEST GENERAL CHAPTER

Q4B ANNEX 6_UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER

Q4B ANNEX 7_DISSOLUTION TEST GENERAL CHAPTER

Q4B ANNEX 8_STERILITY TEST GENERAL CHAPTER

Q4B ANNEX 9_TABLET FRIABILITY GENERAL CHAPTER

Q4B ANNEX 10_POLYACRYLAMIDE GEL ELECTROPHORESIS GENERAL CHAPTER

Q4B_EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

Q5A(R1)_VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN

Q5B_ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS

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Q5C_QUALITY OF BIOTECHNOLOGICAL PRODUCTS – STABILITY TESTING OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q5D_DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q5E_COMPARABILITY OF BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS

Q6B_SPECIFICATIONS – TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS

Q7_GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

Q8(R2)_PHARMACEUTICAL DEVELOPMENT

Q9_QUALITY RISK MANAGEMENT Q10_PHARMACEUTICAL QUALITY SYSTEM

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40 1.12 Stability Workshop ICH Q6A C

E6_R1__Guideline

E9_Guideline

Introduction_to_ICH_Website

Q2_R1__Guideline

Q8_R2_Guideline

ICH guidelines hồ sơ kỹ thuật trong đăng ký dược phẩm dùng cho người

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