Reference Product definition

Reference Product means a biological Prescription Drug.

Reference Product means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which the interchangeable biological product was evaluated by the U.S. Food and Drug Administration pursuant to 42 U.S.C. § 262(k).

Reference Product means the single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application (section 351(i)(4) of the PHS Act).

Examples of Reference Product in a sentence

• All the analytical analyses are done without the knowledge of the Test and the Reference product.

• In order to conclude bioequivalence, the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameters AUC0-t, AUC0-∞ and Cmax should all to be within the 80 to 125% bioequivalence range.

• For the input of Pippin III see: Enright, Iona, Tara, Soissons, p.

• The selected Company will be considered the prime Company and the sole point of contact with regard to all contractual matters.

• Maximum plasma concentrationTime until Cmax is reached 1st Pivotal bioequivalence study:Bioequivalence study of olmesartan and hydrochlorothiazide after single dose administration (fasting conditions) of Olmesartan/HCT 40/25 mg film-coated tablets (Test product) and Olmetec Plus® 40 mg/ 25 mg (Reference product) in30 healthy subjects.

More Definitions of Reference Product

Reference Product means the single biological product licensed

Reference Product has the meaning set forth in the definition of Generic Product.

Reference Product means Lucentis® (Ranibizumab), as approved in the applicable jurisdiction.

Reference Product means Forteo® (teriparatide), as branded and approved in the Territory.

Reference Product means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.

Reference Product means (a) the injectable product containing botulinum neurotoxin serotype A as its sole active ingredient as marketed and manufactured by or on behalf of or under the authority of the Innovator as BOTOX® as of the Effective Date, together with any and all (b) modifications to the foregoing product described in (a) that do not change the function or therapeutic activity (including safety, purity and potency) or that do not require the conduct of a new full clinical program (Phase I through Phase III), (c) additional strengths and concentrations of any such product described in (a) or (b) that do not require the conduct of a new full clinical program (Phase I through Phase III), (d) devices for delivery of any such product described in (a), (b) or (c) by injection, and (e) such products described in (a), (b), (c) or (d) marketed under a different trademark or trade name, in each case ((b)-(e)): marketed and manufactured by or on behalf of or under the authority of the Innovator at any time during the Term. For clarity, the definition of Reference Product expressly excludes [*].

Reference Product means the product currently marketed and sold under the pharmaceutical brand identified in the Amending Product Exhibit.