DMF Equivalent definition

DMF Equivalent means (a) a Drug Master File (as defined in 21 CFR 314.420) with respect to the U.S.; (b) Module 3 of the Common Technical Document with respect to countries in the EU; or (c) any equivalent of any of the foregoing with respect to any country outside the U.S. or EU.

Related to DMF Equivalent

  • Lead equivalent means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

  • Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • USD Equivalent means (i) in respect of each FX Offsetting Transaction, each FX Direct Transaction and each Reverse Dealer Transaction that is a FX Transaction or Currency Option Transaction (assuming (1) the exercise of any Currency Option Transaction and (2) in respect of any Non-Deliverable FX Transaction, the actual exchange of the amounts of the relevant currencies), (y) if there is a USD amount payable either to or by JPMC under such FX Offsetting Transaction, FX Direct Transaction, or Reverse Dealer Transaction, as the case may be, such USD amount or (z) if there is no USD amount payable either to or by JPMC under such FX Offsetting Transaction, FX Direct Transaction, or Reverse Dealer Transaction, as the case may be, then the Dollar Value, determined by JPMC, of the amount of currency payable to JPMC under such FX Offsetting Transaction or Reverse Dealer Transaction, as the case may be, and (ii) in respect of each Bullion Offsetting Transaction, each Bullion Direct Transaction, or Reverse Dealer Transaction that is a Bullion Trade or Bullion Option, as the case may be, (assuming the exercise of any Bullion Option), the Dollar Value, determined by JPMC, of the relevant quantity of Bullion payable to JPMC under such Bullion Offsetting Transaction, Bullion Direct Transaction, or Reverse Dealer Transaction, as the case may be,.

  • Aluminum equivalent means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

  • Effective dose equivalent (HE), means the sum of the products of the dose equivalent to each organ or tissue (HT), and the weighting factor (wT,) applicable to each of the body organs or tissues that are irradiated.

  • Committed dose equivalent (HT,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

  • Morphine equivalent dose means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

  • Effective dose equivalent (HE means the sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

  • Alternative Currency Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in the applicable Alternative Currency as determined by the Administrative Agent or the applicable L/C Issuer, as the case may be, at such time on the basis of the Spot Rate (determined in respect of the most recent Revaluation Date) for the purchase of such Alternative Currency with Dollars.

  • Alternate Currency Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in the applicable Alternate Currency as determined by the Administrative Agent or the applicable Issuing Bank, as the case may be, at such time on the basis of the Spot Rate (determined in respect of the most recent Revaluation Date) for the purchase of such Alternate Currency with Dollars.

  • Sterling Equivalent means at the time of determination thereof (a) with respect to Sterling, the amount in Sterling and (b) with respect to any amount in Dollars, the equivalent of such amount in Sterling determined by Administrative Agent at such time on the basis of the Exchange Rate for the purchase of Sterling with Dollars on the most recent Computation Date provided for in Section 2.8(a).

  • Dose equivalent (HT means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • B/A Equivalent Loan has the meaning assigned to such term in Section 2.06(j).

  • Foreign Currency Equivalent means, with respect to any amount in Dollars, the amount of any Foreign Currency that could be purchased with such amount of Dollars using the reciprocal of the foreign exchange rate(s) specified in the definition of the term “Dollar Equivalent”, as determined by the Administrative Agent.

  • Euro Equivalent means, at any time, with respect to any amount denominated in Dollars, the equivalent amount thereof in Euros as determined by the Administrative Agent or the L/C Issuer, as the case may be, at such time on the basis of the Spot Rate (determined in respect of the most recent Revaluation Date) for the purchase of Euros with Dollars.

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Spousal equivalent means a cohabitant occupying a relationship generally equivalent to that of a spouse.

  • Base Currency Equivalent means, with respect to an amount on a Valuation Date, in the case of an amount denominated in the Base Currency, such Base Currency and, in the case of an amount denominated in a currency other than the Base Currency (the “Other Currency”), the amount of Base Currency required to purchase such amount of the Other Currency at the spot exchange rate determined by the Valuation Agent for value on such Valuation Date.

  • Total effective dose equivalent (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

  • Equivalent Load means the sum of a Market Participant’s net system requirements to serve its customer load in the PJM Region, if any, plus its net bilateral transactions.

  • Interest Equivalent means a yield on a 360-day basis of a discount basis security which is equal to the yield on an equivalent interest-bearing security.

  • Carbon dioxide equivalent or “CO2 equivalent” or “CO2e” means the number of metric tons of CO2 emissions with the same global warming potential as one metric ton of another greenhouse gas. Global warming potential values shall be determined consistent with the definition of Carbon Dioxide Equivalent in MRR section 95102(a).

  • Equivalent Amount of any currency with respect to any amount of Dollars at any date shall mean the equivalent in such currency of such amount of Dollars, calculated on the basis of the Exchange Rate for such other currency at 11:00 a.m., London time, on the date on or as of which such amount is to be determined.

  • Termination Currency Equivalent means, in respect of any amount denominated in the Termination Currency, such Termination Currency amount and, in respect of any amount denominated in a currency other than the Termination Currency (the "Other Currency"), the amount in the Termination Currency determined by the party making the relevant determination as being required to purchase such amount of such Other Currency as at the relevant Early Termination Date, or, if the relevant Market Quotation or Loss (as the case may be), is determined as of a later date, that later date, with the Termination Currency at the rate equal to the spot exchange rate of the foreign exchange agent (selected as provided below) for the purchase of such Other Currency with the Termination Currency at or about 11:00 a.m. (in the city in which such foreign exchange agent is located) on such date as would be customary for the determination of such a rate for the purchase of such Other Currency for value on the relevant Early Termination Date or that later date. The foreign exchange agent will, if only one party is obliged to make a determination under Section 6(e), be selected in good faith by that party and otherwise will be agreed by the parties.

  • U.S. Dollar Equivalent means, on any date of determination, (a) with respect to any amount in US Dollars, such amount, and (b) with respect to any amount in any Alternative Currency, the equivalent in US Dollars of such amount, determined by the Administrative Agent pursuant to Section 1.05 using the Exchange Rate with respect to such Alternative Currency at the time in effect under the provisions of such Section.