Drug Patent Watch

DECEMBER 30, 2024

Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan. Freyr Solutions.

Generic Drugs 52

Generic Drugs Bioequivalency Development Drugs 52

Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Market Size and Potential Generic manufacturers are more likely to target drugs with a large market size and high sales volume. This complexity can serve as a barrier to entry for potential generic manufacturers.

Licensing 96

Licensing Licensing Branding Drugs 96

FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105

Camargo

DECEMBER 22, 2021

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. This is a key factor in designing Phase 2 and 3 trials.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

Development 161

Development Production Immune Response Licensing 161

Camargo

FEBRUARY 10, 2021

Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. This blog post will discuss how PK modeling can contribute to sample size estimation, a key aspect of a clinical trial protocol.

Production 133

Production Bioavailability In-Vivo In-Vitro 133