ALCOHOLIC PAIRED YOYO® BITTERS INDUCES LEYDIG CELL ATYPIA IN RATTUS NOVERGICUS Journal title: World Journal of Pharmaceutical and life sciences Authors: Oboma Yibala I. Subject(s):
DRUG UTILIZATION PATTERN AND POTENTIAL TERATOGENESITY RISK AMONG PREGNANT WOMEN; NEKEMTE REFERRAL HOSPITAL, EAST WOLLEGA ZONE, OROMIA REGIONAL STATE, ETHIOPIA Journal title: INTERNATIONAL JOURNAL OF MODERN PHARMACEUTICAL RESEARCH Authors: Dinka Dugassa Subject(s):
ROLE OF DRUG REGULATORY AFFAIRS IN PHARMA INDUSTRY Journal title: WORLD JOURNAL PHARMACY AND PHARMACEUTICAL SCIENCE Authors: Avinash Darekar Subject(s):
MARKETING AUTHORIZATION AND STRATEGIES FOR THE PROMOTION OF DRUGS IN INDIA, EUROPE AND USA Journal title: WORLD JOURNAL PHARMACY AND PHARMACEUTICAL SCIENCE Authors: Nuthalakanti Nandini Subject(s):
REGULATORY GUIDELINES FOR APPROVAL OF BIOSIMILARS IN INDIA, UNITED STATES AND EUROPE - A COMPREHENSIVE SUMMARY Journal title: WORLD JOURNAL PHARMACY AND PHARMACEUTICAL SCIENCE Authors: Sai Sarvani Piratla Subject(s):
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Effect of 2016 FDA guidance on study population and clinical response rates in patients with bacterial vaginosis: a phase 3 post hoc analysis Journal title: Clinical and Experimental Obstetrics & Gynecology Authors: P. Nyirjesy, M. Padula, J.L. Amprey Subject(s):
To give or not to give: Parental experience and adherence to the Food and Drug Administration warning about over-the-counter cough and cold medicine usage Journal title: Judgment and Decision Making Authors: Talya Miron-Shatz, Greg Barron, Yaniv Hanoch, Michaela Gummerum and Glen M. Doniger Subject(s): Philosophy, Psychology, Social Sciences
Summary Report of PQRI Workshop on Nanomaterial in Drug Products: Current Experience and Management of Potential Risks Journal title: The AAPS Journal Authors: Jeremy A. Bartlett, Marcus Brewster, Paul Brown, Donna Cabral-Lilly, Celia N. Cruz, Raymond David, W... Subject(s): Medicine
Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance Journal title: The AAPS Journal Authors: Brian Booth, Mark E. Arnold, Binodh DeSilva, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Go... Subject(s): Medicine
Safety of β2-Agonists in Asthma: Linking Mechanisms, Meta-Analyses and Regulatory Practice Journal title: The AAPS Journal Authors: Sanjeeva. B. Dissanayake Subject(s): Medicine
Drug Discovery and Regulatory Considerations for Improving In Silico and In Vitro Predictions that Use Caco-2 as a Surrogate for Human Intestinal Permeability Measurements Journal title: The AAPS Journal Authors: Caroline A. Larregieu, Leslie Z. Benet Subject(s): Medicine
Regulatory Administrative Databases in FDA's Center for Biologics Evaluation and Research: Convergence Toward a Unified Database Journal title: The AAPS Journal Authors: Jeffrey K. Smith Subject(s): Medicine
Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA Journal title: The AAPS Journal Authors: Qing Liu, Barbara M. Davit, Svetlana A. Cherstniakova, Suman Dandamudi, Johnetta F. Walters, Christi... Subject(s): Medicine
A History of Biopharmaceutics in the Food and Drug Administration 1968–1993 Journal title: The AAPS Journal Authors: Jerome Philip Skelly Subject(s): Medicine