Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence. [PDF]
CPT Pharmacometrics Syst PharmacolABSTRACT Talazoparib is a poly(ADP‐ribose) polymerase inhibitor approved for the treatment of breast and prostate cancer. Commercialization of a soft gelatin capsule (SGC) formulation developed post‐approval required a bioequivalence (BE) and food effect (FE) study to bridge SGC with the initial commercial hard capsule (HC) formulation. Study execution
Wang D +10 more
europepmc +2 more sources
A survey of regulatory recommendations for waivers of <i>in vivo</i> bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2. [PDF]
J Pharm Pharm SciGarcía-Arieta A +37 more
europepmc +3 more sources
Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry [PDF]
, 2010 Patent holders frequently attempt to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry (early entry). Competition in off-patent pharmaceutical markets may be adversely affected if early entry substantially impairs ...
Appelt, Silvia
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A SURVEY OF THE LIKELIHOOD APPROACH TO BIOEQUIVALENCE TRIALS [PDF]
, 2007 Bioequivalence trials are abbreviated clinical trials whereby a generic drug or new formulation is evaluated to determine if it is equivalent to a corresponding previously approved brand-name drug or formulation.
Caffo, Brian S. +2 more
core +2 more sources
Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria [PDF]
, 2017 Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for ...
Darwich Adam S. +4 more
core +1 more source
Low-level seaweed supplementation improves iodine status in iodine-insufficient women [PDF]
, 2014 Iodine insufficiency is now a prominent issue in the UK and other European countries due to low intakes of dairy products and seafood (especially where iodine fortification is not in place).
Combet, Emilie +4 more
core +2 more sources
Optimal testing of equivalence hypotheses
, 2005 In this paper we consider the construction of optimal tests of equivalence hypotheses. Specifically, assume X_1,..., X_n are i.i.d. with distribution P_{\theta}, with \theta \in R^k. Let g(\theta) be some real-valued parameter of interest.
Romano, Joseph P.
core +2 more sources
Consistency of the Bootstrap Procedure in Individual Bioequivalence [PDF]
, 1999 Recently, new concepts have been proposed for assessing bioequivalence of two drug formulations, namely the so-called population and individual bioequivalence.
Kübler, J., Pigeot, Iris, Shao, J.
core +2 more sources
Early detection of biochemically occult autonomous thyroid nodules [PDF]
, 2016 Objective: Autonomously functioning thyroid areas may be associated with subclinical or overt hyperthyroidism, but may exist even in the presence of normal TSH.
Brusca, Nunzia +7 more
core +1 more source
British Journal of Clinical Pharmacology, EarlyView.Aims Resistance to the artemisinins and the artemisinin‐based combination therapy (ACT) partner drugs has developed in Southeast Asia, and artemisinin resistance has also emerged in eastern Africa. Triple ACTs (triple artemisinin‐based combination therapies, TACT), consisting of two partner drugs with different mechanisms of action and similar ...
Junjie Ding +24 more
wiley +1 more source