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Documents Impurities in Drugs

http://stabilitystudies.blogspot.com Drug Substance and Drug Product http://stabilitystudies.blogspot.com 1 Impurity  Any component of the new drug substance that is not…

Health & Medicine Usp chemical medicines & excipients - evolution of validation practices

Track I, Session I: Chemical Medicines and Excipients-Evolution of Validation Practices Wednesday, April 17, 2013 (9:00 a.m. to 11:00 a.m.) IPC–USP Science & Standards…

Technology Analytical method validation workshop

Analytical Method and Validation Siham Abdoun Mohamed Msc., PhD ANALYTICAL PROCEDURE The analytical procedure refers to the way of performing the analysis. It should describe…

Technology International conference on harmonisation validation of analytical procedures

International Conference on Harmonisation International Conference on Harmonization Validation of Analytical Procedure Q2(R1) Part 1 Text on Validation of Analytical Procedures.…

Documents Cmc Review -Xolair

D EPARTMENT OF H EALTH & HUMAN SERVICES Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Bethesda, MD 20892 Date From : : June 20,…

Documents Stability of phrmaceutical product

ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Now our concern is “QUALITY guideline”,…

Documents Generic Modified Release Drug Products

Quality by Design Example forGeneric Modified Release Drug Products

Documents spheronization

Seminar On SPHERONIZATION V.Vishala M.Pharm Industrial Pharmacy (1st Sem) St.PETER’S INSTITUTE OF PHARMACEUTICAL SCIENCES VIDYA NAGAR, HANAMKONDA. WARANGAL 506001 CONTENTS…

Documents 2 4 Method Validation HPLC Case Study

Method and Validation basics —HPLC case study Hua YIN (Assessor) Outline  HPLC methodology - Content of HPLC test procedure - System Suitability Testing (SST) - Relative…