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1. A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH. Issue 6 (16th August 2019)

2. A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials. Issue 5 (3rd July 2019)

3. Application of Clinical Pharmacology Principles in Drug Development of Modified‐Release Products: Leveraging Exposure‐Response Information to Support Approval. (26th May 2020)

4. Assessment of Similarity in Antipsychotic Exposure‐Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia. (28th January 2020)

5. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam. Issue 9 (6th February 2015)

6. Biowaiver Monographs for Immediate‐Release Solid Oral Dosage Forms: Nifedipine. Issue 10 (6th July 2015)

8. Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder. (29th June 2021)

9. Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective. Issue 4 (3rd July 2022)

10. Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration. Issue 1 (6th November 2020)