Therapeutic Differences in 24-h Ambulatory Blood Pressures in Patients Switched Between Bioequivalent Nifedipine Osmotic Systems With Differing Delivery Technologies

Author:

Pollak PT1,Herman RJ1,Feldman RD2

Affiliation:

1. University of Calgary; Calgary Alberta Canada

2. Memorial University; St John's, Newfoundland & Labrador Canada

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference38 articles.

1. Health Canada Guidance document: Conduct and analysis of comparative bioavailability studies 2016 http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/gd_cbs_ebc_ld-eng.php

2. Canadian Agency for Drugs and Technologies in Health (CADTH) What are bioavailability and bioequivalence 2016 https://www.cadth.ca/media/pdf/Generic_prof_supplement_en.pdf

3. Mean apical concentration and duration in the comparative bioavailability of slowly absorbed and eliminated drug preparations;Pollak;J. Pharm. Sci.,1988

4. European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit Note for guidance on modified release oral and transdermal dosage forms: Section II (Pharmacokinetic and clinical evaluation) [Internet] 2016 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003126.pdf

5. European Medicines Agency Guideline on the investigation of bioequivalence [Internet] http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf

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