Bioequivalence and Bioavailability Forum • Calories ;-)

Calories ;-) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-01-29 20:22 (5977 d 05:43 ago) – Posting: # 4663
Views: 28,295

Hi ElMaestro!

❝ […] Business as usual.

Found another gem. I know that units are a very difficult topic. FDA and our Canadian friends failed as well in distinguishing calories and kilocalories.

4.1.4 Study conduct, Fasting or fed conditions

[...] the meal should be a high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The composition of the meal should be described with regard to protein, carbohydrate and fat content (specified in grams, calories and relative caloric content (%)).

OK, here comes my suggestion:

                   caloric breakdown (cal)

--------------------------------------------------

                        carbo-

              protein   hydrate    fat     total

--------------------------------------------------

123 mg toast    46.1     203.0     33.5    282.6

 50 mg butter    0.0       1.7    452.0    453.7

350 µL milk     47.3      58.3    124.2    229.8

--------------------------------------------------

total calories  93.5     263.0    609.6    966.1

target cal.    150       250     500-600  800-1000

% of total       9.7      27.2     63.1

Not perfect, but a first try. Protein is difficult to match, maybe I add a quarter soybean to the meal and serve only 100 mg of toast instead.

P.S.: I’m quite happy with my body mass of 72 kilograms. 72 grams with my size would give my enough bouyancy to reach the stratosphere. On the other hand keeping my specific weight and BMI I would only measure 5.7 centimetres (slightly smaller than a mouse). Luckily I don’t have a cat at home.

Edit: Was corrected in March 2010. See here. [Helmut]

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Complete thread:

EMA BE guideline - final version Ohlbe 2010-01-28 18:31 [Regulatives / Guidelines]
- Final version published Helmut 2010-01-29 14:29
  - Final version published ElMaestro 2010-01-29 17:02
    - Statistix Helmut 2010-01-29 17:30
      - Statistix ElMaestro 2010-01-29 18:11
    - Calories ;-)Helmut 2010-01-29 19:22
      - Calories ;-) ElMaestro 2010-01-29 20:43
        
        Calories ;-) Helmut 2010-01-29 21:08
      - Variable calories d_labes 2010-02-01 12:05
    - ANOVA only - no doubts Helmut 2010-02-10 23:41
      - ANOVA only - no doubts ElMaestro 2010-02-12 21:09
  - Final EMA oracle d_labes 2010-02-01 11:53
    - Final EMA oracle Helmut 2010-02-01 12:28
    - Final EMA oracle ElMaestro 2010-02-01 12:50
      - More then two EMA oracles d_labes 2010-02-01 13:30
        
        Less of an issue ElMaestro 2010-02-01 15:29
        
        Less or More of an issue d_labes 2010-02-01 16:53
        
        Less or More of an issue ElMaestro 2010-02-01 17:22
        
        Effective with 1 Aug 2010 Helmut 2010-02-02 00:55
        Bias? ElMaestro 2010-02-04 11:27
        
        Bias? Helmut 2010-02-05 02:03
        
        Bias? ElMaestro 2010-02-05 09:33
        
        Bias? Helmut 2010-02-05 10:21
        
        Bias? d_labes 2010-02-05 13:59
        Bias? ElMaestro 2010-02-05 16:00
        
        Bias? Helmut 2010-02-05 19:14
      - Final EMA oracle Helmut 2010-02-01 13:43
        
        Final EMA oracle ElMaestro 2010-02-01 14:54
        
        Final EMA oracle d_labes 2010-02-01 15:20
        
        Teaching Helmut 2010-02-01 16:07
  - Cmin really gone? tmax reappeared? d_labes 2010-02-01 14:02
    - Cmin really gone. tmax reappeared - but how? Helmut 2010-02-01 23:30
  - Interpol or not d_labes 2010-02-01 14:52
    - Interpol! Helmut 2010-02-02 00:02
      - Interpol! ray_be 2010-02-03 18:31
        
        WinNonlin/Phoenix extrapolation to t=tau Helmut 2010-02-03 20:26
  - Meta-analysis Helmut 2010-02-07 17:41
  - Final version published Panks.79 2010-03-08 07:22
    - Cmin for MR-formulations? Helmut 2010-03-08 18:16
      - Cmin for MR-formulations? Marcel 2010-04-23 10:09
        
        MR-Guideline? Helmut 2010-04-23 12:34
- Overview of comments published Helmut 2010-02-10 18:33
  - Comments commented d_labes 2010-02-11 08:19
  - Definition of Cmin by EMEA Ravi 2010-03-13 12:05
    - The EMA’s Cmin & WinNonlin Helmut 2010-03-13 12:52