Remove 2023 Remove Clinical Pharmacology Remove Drug Development
article thumbnail

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. Rodrigues AD. 113:9861002.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. On Demand Start Date Tue, 12/05/2023 - 12:00 Click here to login.

article thumbnail

Antibody Drug Conjugates: windows of opportunity

Drug Target Review

Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. With the ultimate long-term goal of optimum dosing being determined before Phase 3 registration trials and before a drug is marketed. 2022 Nov 14 [cited 2023 Apr 6];40(11):1255–63.

article thumbnail

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Cytel

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

article thumbnail

Angel Reyes Joins Altasciences as General Manager of CDMO Services

Alta Sciences

Angel Reyes Joins Altasciences as General Manager of CDMO Services pmjackson Thu, 10/05/2023 - 18:55 Laval, Québec, Friday, October 6, 2023 – Altasciences is pleased to welcome Angel Reyes as General Manager, Contract Development and Manufacturing Organization (CDMO) Services.

article thumbnail

Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri

Alta Sciences

Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri pmjackson Tue, 10/31/2023 - 16:08 Laval, Québec, October 31, 2023 – Altasciences is pleased to announce the completion of its laboratory facilities in Columbia, MO.