Upload File

clinical pharmacology biopharmaceutics review(s) - accessdata fda

  • Home
  • Documents
  • Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
44

Upload: others

Post on 09-Feb-2022

6 views

Category:

Documents


0 download

Report

TRANSCRIPT

Page 1: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 2: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 3: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 4: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 5: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 6: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 7: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 8: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 9: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 10: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 11: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 12: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 13: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 14: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 15: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 16: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 17: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 18: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 19: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 20: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 21: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 22: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 23: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 24: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 25: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 26: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 27: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 28: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 29: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 30: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 31: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 32: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 33: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 34: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 35: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 36: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 37: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 38: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 39: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 40: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 41: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 42: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 43: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA
Page 44: Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA

208078Orig1s000 - Food and Drug Administration€¦ · 208078Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) 1 Office of Clinical Pharmacology Review Addendum (Erratum)

21154 Nexium Clinical Pharmacology Biopharmaceutics Review ...€¦ · Title: 21154 Nexium Clinical Pharmacology Biopharmaceutics Review Part 2 Created Date: 8/23/2001 11:39:00 AM

Clinical Pharacology and Biopharmaceutics Review(s) · 2019-04-04 · BIOPHARMACEUTICS REVIEW(S) 1 Office of Clinical Pharmacology Review ... 2.1 Pharmacology/Clinical Pharmacokinetics

CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) - Food and Drug … · 2011-07-20 · The Office of Clinical pharmacology, Division of Clinical Pharmacology V has reviewed the

21-360 Efavirenz Clinical Pharmacology Biopharmaceutics Review

CLINICAL PHARMACOLOGY REVIEW€¦ · 21/12/2007  · the Clinical Pharmacology and Biopharmaceutics reviews of Kaletra capsule formulation (NDA 21-226). Lopinavir trough plasma concentration

20-272S007 Biopharm Review Rwperdal Clinical Pharmacology … · 2009. 3. 31. · Title: 20-272S007 Biopharm Review Rwperdal Clinical Pharmacology Biopharmaceutics Review Part 3 Created

206911Orig1s000 - Food and Drug Administration · PDF file206911Orig1s000 . CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA:

Clinical Pharmacology and Biopharmaceutics Review(s) · 2019-06-03 · CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) (b) (4) Office of Clinical Pharmacology Review. NDA or

125418Orig1s000 - Food and Drug Administration€¦ · 125418Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) Clinical Pharmacology Review ... progressed after an oxaliplatin-containing

Clinical Pharmacology & Biopharmaceutics

Quality Systems for Clinical Pharmacology and Biopharmaceutics Review Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics

Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application

CLINICAL PHARMACOLOGY & BIOPHARMACEUTICS REVIEW … · CLINICAL PHARMACOLOGY & BIOPHARMACEUTICS REVIEW ... metoprolol succinate extended release tablets. ... Food does not affect

21174 Mylotarg for Injection Clinical Pharmacology Biopharmaceutics Revi … · 2009. 4. 16. · Title: 21174 Mylotarg for Injection Clinical Pharmacology Biopharmaceutics Revi ew

21-146 Atropine Sulfate Clinical Pharmacology Biopharmaceutics … · 2009. 4. 21. · Title: 21-146 Atropine Sulfate Clinical Pharmacology Biopharmaceutics Review Created Date: 10/11/2001

201820Orig1s000 - accessdata.fda.gov › ... › nda › 2012 › 201820Orig1s000C… · 201820Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OFFICE OF CLINICAL PHARMACOLOGY

205858Orig1s000 - Food and Drug Administration...205858Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) Page 1 of 45 Office of Clinical Pharmacology NDA Review Number

Clinical Pharmacology Biopharmaceutics Review(s)

CLINICAL PHARMACOLOGY REVIEW - accessdata.fda.gov€¦ · 2 1.1 Recommendations 3 1.2 Phase 4 Commitments 3 1.3 Summary of Important Clinical Pharmacology and Biopharmaceutics Findings

21-045 Plan B Clinical Pharmacology Biopharmaceutics Review · Title: 21-045 Plan B Clinical Pharmacology Biopharmaceutics Review Created Date: 6/22/2001 11:08:10 AM

Clinical Pharmacology and Biopharmaceutics Review(s)...2.1 Clinical Pharmacology and Pharmacokinetics PF-05280014 is a proposed biosimilar to US-licensed Herceptin. US-licensed Herceptin

21-196 Xyrem Clinical Pharmacology Biopharmaceutics Review ... · PDF fileTitle: 21-196 Xyrem Clinical Pharmacology Biopharmaceutics Review Part 1 Created Date: 10/9/2002 10:26:33

clinical pharmacology and biopharmaceutics - Accessdata FDA

Clinical Pharmacology and Biopharmaceutics Review(s)The Office of Clinical Pharmacology, Divisions of Clinical Pharmacology I and Pharmacometrics, have reviewed the information contained

21-434 Xanax Clinical Pharmacology Biopharmaceutics Review …€¦ · Title: 21-434 Xanax Clinical Pharmacology Biopharmaceutics Review Part 1 Created Date: 11/15/2004 2:11:26 PM

202880Orig1s000 - Food and Drug Administration · 202880Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) 1 BIOPHARMACEUTICS REVIEW Office of New Drug Quality Assessment

Pharmacology Review(s) - Accessdata FDA

CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW… · center for drug evaluation and research application number: 202107orig1s000 clinical pharmacology and biopharmaceutics review(s)

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION … · The Office of Clinical Pharmacology (OCP) has reviewed the data submitted to the Clinical Pharmacology and Biopharmaceutics

208547Orig1s000 - Food and Drug Administration · 208547Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) NDA 208547 Review – Ga-68-DOTA-TATE 1 Clinical Pharmacology

OFFICE OF CLINICAL PHARMACOLOGY AND …€¦ · Yuanchao (Derek) Zhang, Ph.D. Pharmacokinetics Reviewer, DPE III Office of Clinical Pharmacology and Biopharmaceutics. Concurrence:

CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW… · CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) Page 1 of 7 Office of Clinical Pharmacology ... procedures and validation

21-535 Clobex Clinical Pharmacology Biopharmaceutics Review · Title: 21-535 Clobex Clinical Pharmacology Biopharmaceutics Review Created Date: 6/1/2004 8:33:23 AM

Clinical Pharmacology and Biopharmaceutics Review · 2017-12-22 · Clinical Pharmacology and Biopharmaceutics Review NDA 21,228/20,771 Submission Date October 10, 2003 Brand Name