The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 ...

and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological assays to determine concentration of drugs in biological fluids ...

The 95% CIs of the differences between healing rates indicate that lansoprazole 30mg and esomeprazole 40mg produce equivalent healing rates of erosive oesophagitis after 4 weeks and 8 weeks of ...

The Federal Trade Commission (FTC) has escalated its efforts to address improper patent listings that hinder generic competition and keep drug prices high. On May 21, the ...

Evidence supporting the therapeutic equivalence of generic ICS-LABAs for use in COPD thus remains valuable given actual prescribing patterns.” The researchers pointed out that the study ...

Approved Drug Products with Therapeutic Equivalence Evaluations, or “Orange Book” as it is more commonly known. As explained more fully below, the Orange Book lists all drugs that the FDA has ...

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter ...

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