Therapeutic Equivalence
Found 4 free book(s)
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …
www.ema.europa.eudemonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (copd) in adults and for use in the treatment of asthma in children and adolescents . discussion at the efficacy working party . september 2000.
Comparison of pharmacokinetics and efficacy of oral and ...
www.who.intequivalence Studies reporting parenteral benefit Studies reporting equivalence Studies reporting parenteral benefit Otitis media 4 4/4 0/4 NA NA Pneumonia 3 2/3 1/3* 0/1 1/1* ... high end of the therapeutic range given more frequently • The pharmacokinetic advantage of parenteral over
Therapeutic Equivalence = Bioequivalence + Pharmaceutical ...
bmctoday.netTherapeutic Equivalence = Bioequivalence + Pharmaceutical Equivalence Drugs are considered to be therapeutic equivalents and thus suitable for substitution (generic equivalents) if, among other factors, they are both pharmaceutical equivalents and bioequivalent. Therapeutic Equivalents: Drug products are considered to be therapeutic equivalents
E 3 Structure and Content of Clinical Study Reports
www.ema.europa.euindividual study of any therapeutic, prophylactic or diagnostic agent (referred to herein as drug or treatment) conducted in patients, in which the clinical and statistical description, presentations, and analyses are integrated into a single report, incorporating tables and figures