Announcement

Pharmaceutical Development and GMP

Response to the feedback on Mock P2 with Enhanced Approach(2010)

------English Mock QOS P2 Revised version(2010)------

------English Mock Application Form(2010)------

Pharmaceutical Development P2 with Enhanced Approach(2008)

------Mock P2 English(FileC)(2008)------

Draft GMP Guidelines For Comments (2004)

Bioequivalence

Guideline for Bioequivalence Studies of Generic Products for Topical Use (2003) (pdf file)

Guideline for Bioequivalence Studies for Different Strengths of Oral Solid Dosage Forms (2006) (pdf file)

Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms (2006) (pdf file)

Guideline for Bioequivalence Studies of Generic Products (2006)(pdf file)

Old guidelines (BE guiide 1997 | formulation change 2000 | different strength 2000)

Others

Bioanalytical Method Validation and related areas.

Validation of Analytical Procedures: Methodology (1996) Step 4, Consensus Guideline (obtained from EMEA)

Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988) (pdf file)

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Last edition: Jan. 18, 2011