Search results: Sage Journals

Retricted accessResearch articleFirst published November, 2013

Statistics,Quality Review Issues,and Beyond for Generic Drug Applications in Taiwan

Lin-Chau Chang, Churn-Shiouh Gau

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published September, 2019

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Jason Woo, Jingyu (Julia) Luan, Zili Li [...]

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published December, 2003

Gain-of-Function Somatic Cell Lines for Drug Discovery Applications Generated by Homologous Recombination

Karin Zeh, Pamela Sanders, Phillip Londo [...]

ASSAY and Drug Development Technologies

Free accessResearch articleFirst published October, 2004

A Generally Applicable,High-Throughput Screening–Compatible Assay to Identify,Evaluate,and Optimize Antimicrobial Agents for Drug Therapy

Gerald Kleymann, Hans-Otto Werling

Journal of Biomolecular Screening

Retricted accessResearch articleFirst published October, 2020

Application of KW-ANOVA statistics to generate evidence for cytotoxic drug wastage induced financial burden among cancer patients: A clinical pharmacist observation

K Jyoti, G Manjula, MS Ganachari

Journal of Oncology Pharmacy Practice

Retricted accessResearch articleFirst published October, 2011

Globalizing the FDA: Achieving safety,access,and transparency through a comprehensive Generic Drug User Fee Program *

Debbie Jaskot, Gordon Johnston, Marcie E McClintic Coates [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessReview articleFirst published September, 2023

Generic drug application and approval process in Vietnam and Philippines

Sayali C Kankariya, Atish S Mundada

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted accessResearch articleFirst published July, 2007

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessReview articleFirst published September, 2019

Generic drugs,a need to the public: USA and India – Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018

Russell Martin, Kavita Bahmani

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessResearch articleFirst published October, 2010

Application of a Droplet Evaporation Model to Aerodynamic Size Measurement of Drug Aerosols Generated by a Vibrating Mesh Nebulizer

Nagaraja Rao, Nani Kadrichu, Brian Ament

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Retricted accessResearch articleFirst published November, 2013

Statistics,Quality Review Issues,and Beyond for Generic Drug Applications in Taiwan

Lin-Chau Chang, Churn-Shiouh Gau

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published September, 2019

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Jason Woo, Jingyu (Julia) Luan, Zili Li [...]

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published December, 2003

Gain-of-Function Somatic Cell Lines for Drug Discovery Applications Generated by Homologous Recombination

Karin Zeh, Pamela Sanders, Phillip Londo [...]

ASSAY and Drug Development Technologies

Free accessResearch articleFirst published October, 2004

A Generally Applicable,High-Throughput Screening–Compatible Assay to Identify,Evaluate,and Optimize Antimicrobial Agents for Drug Therapy

Gerald Kleymann, Hans-Otto Werling

Journal of Biomolecular Screening

Retricted accessResearch articleFirst published October, 2020

Application of KW-ANOVA statistics to generate evidence for cytotoxic drug wastage induced financial burden among cancer patients: A clinical pharmacist observation

K Jyoti, G Manjula, MS Ganachari

Journal of Oncology Pharmacy Practice

Retricted accessResearch articleFirst published October, 2011

Globalizing the FDA: Achieving safety,access,and transparency through a comprehensive Generic Drug User Fee Program *

Debbie Jaskot, Gordon Johnston, Marcie E McClintic Coates [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessReview articleFirst published September, 2023

Generic drug application and approval process in Vietnam and Philippines

Sayali C Kankariya, Atish S Mundada

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted accessResearch articleFirst published July, 2007

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessReview articleFirst published September, 2019

Generic drugs,a need to the public: USA and India – Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018

Russell Martin, Kavita Bahmani

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Available accessResearch articleFirst published October, 2010

Application of a Droplet Evaporation Model to Aerodynamic Size Measurement of Drug Aerosols Generated by a Vibrating Mesh Nebulizer

Nagaraja Rao, Nani Kadrichu, Brian Ament

Journal of Aerosol Medicine and Pulmonary Drug Delivery